E - MobiHealth
Contents
1. Batteries battery power was the same as with Pre Trial 1 The relatively short battery life on the system meant it was advisable to leave it on the charger in some cases Some trial owners noted that 64 66 the batteries needed to be almost full in order to establish a good connection Mobility it was generally agreed that a person wearing the system could be mobile the critical factor was the battery life The factor that is important here is that if the iPAQ is charging the maximum distance the user can have from it is dependent on Bluetooth To get full mobility in this pre trial the critical factor is the battery consumption in the iPAQ Participants may wish to be outdoors for many hours Wearability with the greater amount of testing afforded by this pre trial there was general consensus that the MobiHealth system was easy even for a patient to put on by themselves and wear for long periods and that in most cases it was unrestrictive to daily activities One trial owner considered the iPAQ and GPRS device are a little heavy for elderly or infirm people to carry Visibility of errors on iPAQ the request from Pre Trial 1 that there be some kind of sign if the iPAQ was disconnected or not functioning properly was answered Trial owners reported an improvement here although there was the question of the Sending indicator and the relation between apparent sending time and actual data transmitted One tri2. ECG measurements could be viewed on the IPAQ and seemed to be valid Sweden Trial 1 The Lighthouse alarm and locator This is now good Special UMTS trial The sensor viewer crashed easily when changing between the sensors to view Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis There is no problem to see the signals on the sensor viewer Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 reports that the sensor view fully complied with the specification Trial owner 2 reports when starting up the first session on Saturday when pressing the button for the sensor viewer the message Check Mobi came up She pressed OK and then a picture came up that she had never seen before she took a photo of it and e mailed it later on to Telia She reported the error verbally on Monday or Tuesday to Telia After resetting the iPAQ and GPRS there was no problem with the sensor viewer in any of the three sessions The signals had good quality and were viewable Trial 4 Home care and remote consultation for recently released patients in a rural area Four times there were problems seeing in the sensor view Not all 3 lead ECG readings or saturation were visible in the view Once the curve stayed on the viewer for a minute after the sensor view had been closed 22 66 Spain Trial 1 Support of home based healthcare services The se
3. data to the trauma hospital There was no pre trial on this occasion however some testing of the UMTS network and connectivity was performed and many of the technical usability tests from the other Enschede trial had application in this trial so the results are merged in the evaluation Trial 2 Integrated home care for women with high risk pregnancies The purpose of this study is to evaluate whether monitoring at a distance of vital signs e g CTG maternal blood pressure is feasible safe and can postpone hospitalization for women with a high risk pregnancy This pre trial monitored ten healthy pregnant women at a hospital and two at home 5 66 Part One Field Pre Trial Details per Site Please provide comments on the circumstances and procedures of the pre trial s you ran under the following headings Testing period Germany Trial 1 Secondary prevention in coronary heart disease This pre trial ran 12 December 15 December Sweden Trial 1 The Lighthouse alarm and locator 24th 26th 28 November and ond December a total of circa 25 hours Special UMTS trial 9 December 2003 between 19 51 20 02 Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis The trial ran on 12 December 2003 from 10 00 to 11 30 Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency The first pre trial of this phase took place on 27 to 28 Novem
4. the indicator of data being sent does not appear on the screen of the PDA and therefore data is not stored at the BEsys There are some cases in which the data seems to be sent to the server because the message sending data appears in the PDA but when the stored data is accessed only 1 or 2 K have been stored or no data has been stored It is not stable at all UMTS Usually data is sent without problems In some very punctual cases it is needed to restart the iPAQ and then you can send with no problems Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies Duration of transmission was between two and four hours on GPRS regardless of whether transmission was using sleeve or separate Nokia as a modem and regardless of testing area Each time the iPAQ reported a normal sending mode while the Mobi switched off No reason for this is known Transmission with UMTS was up to 8 hours depending on network coverage 19 66 Mobi iPAQ Back End system communication Germany Trial 1 Secondary prevention in coronary heart disease The communication between the iPAQ and Mobi is widely stable connection breaks down after 30 60 minutes of measurement Sweden Trial 1 The Lighthouse alarm and locator Communication has improved however there are still some disconnections between the systems fewer t
5. input Special UMTS trial 4 lead ECG activity sensor marker alarm button Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis 3 lead ECG activity sensor Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency In the first trial the parameters were pulse oximetry 3 lead ECG and an activity sensor In the second they were the activity Sensor all sessions pulse oximeter all sessions and 3 lead ECG test person 2 Trial 4 Home care and remote consultation for recently released patients in a rural area 3 lead ECG and pulse oximeter Spain Trial 1 Support of home based healthcare services SatO2 ECG Movement 14 66 Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies ECG leads on Pregnancy BAN Pulse oximetry on Trauma BAN 15 66 Part Two Outcome Assessment Please indicate what occurred while carrying out the following activities on the current prototype Version 3 1 of the BAN and communications system in the pre trial s you ran under the following headings Activating iPAQ Germany Trial 1 Secondary prevention in coronary heart disease The activation of the iPAQs was in the current prototype version no greater problem The iPAQ and Mobi still had to be rebooted after every measuremen
6. personnel in the Lighthouse and two independent testers in the city and surrounding environment This trial also provided more intensive testing of the UMTS capabilities Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis The aim of the trial is to follow the patients activity level during the course of a week by means of continuous monitoring of heart rate and self reporting of the activity level monitoring walking distance to determine the factors that impede the patient from performing those activities that she wishes to perform The primary research question is to examine the correspondence of heart data and monitored activity to the self reports of activity level It is also intended to evaluate how the women experience using the mobile technological devices In this pre trial the trial owner tested the system with a test subject at the Department of Health Science Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency The end trial is to examine whether mobile health facilities with monitoring of some relevant vital signs can contribute to an earlier detection and treatment of COPD and also reduce the need for check ups and hospitalisation In this pre trial two professionals and one test person wore and tested the unit over several days performing different activities Subsequently an elderly test subject conducted a test for six hours with the system under supervi
7. 2004 Following identical procedure for Pre Trial 1 the user evaluation of Pre Trial 2 is based on a questionnaire filled in by each trial owner having completed their pre trial The sections below quote directly from the answers given A brief description of each trial follows Germany Trial 1 Secondary prevention in coronary heart disease In the future trial the patient is able to transmit ECG and blood pressure via GPRS from home or elsewhere to the health call centre where the vital signs are monitored by a cardiologist The intention is that irregular patterns in these vital signs will be quickly detected and appropriate intervention can be effectuated The trials are designed to determine whether 2 5 3G wireless communications can support such services In this pre trial the unit was tested by several medical and technical personnel cardiologists and technicians and two cardiac patients as well as persons at the call centre Sweden Trial 1 The Lighthouse alarm and locator The purpose of the Lighthouse trial is to test the effectiveness of a new GPRS UMTS based personal alarm and locating device for clients of the care centre especially the elderly and the personnel according to several determining factors safety convenience empowerment of user mobility of user and improvement in efficiency of care given In 3 66 this pre trial the connectivity and positioning were tested by the trial owner and two care
8. D41AMLE Mobi 0924030012 Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency In the first trial the BAN was LTU 020 2 with the RespInsuff package of sensors In the second it was LTU018 ID 4G2RAW34N07D Mobi SN 0924030021 Trial 4 Home care and remote consultation for recently released patients in a rural area iPAQ S N 4g2adw34n089 Mobi S N 0924030026 12 66 Spain Trial 1 Support of home based healthcare services IPAQ 4G28DW34R05T Mobi 0924030018 IPAQ 4G27DW34R04P Mobi 0924030036 IPAQ 4G28DW34RO05W Mobi 0924030044 IPAQ 4G27DW34R04D Mobi 0924030037 IPAQ 4G28DW34R05D Mobi 0924030015 GPRS WLAN NOKIA D211 PCMCIA provided by the hospital CSC SIMs for GPRS connection provided by Telef nica M viles UMTS IPAQ 4G27DW34R04R Mobi 0924030031 Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies 0924030061 MST 005 Ipac 4G2ADW3N06P 0924030062 MST 007 Ipac 4G2ADW34N03C MST 006 Ipac 02X MST 008 Ipac Trauma Mobi was returned to UT Ipac 4G24DW3V2ZO Nokia 027459 6 13 66 Sensors tested parameters measured Germany Trial 1 Secondary prevention in coronary heart disease ECG 3 lead Alarm button Sweden Trial 1 The Lighthouse alarm and locator Location marker ECG drop sensor and manual
9. DYA a x JIN Informati pS ociety European Commission M 0 B H EA LTH IST Programme Project Number IST 2001 36006 Acronym MobiHealth A project funded by the European Community under the Information Society Technologies Programme 1998 2002 Pre Trial User Evaluation Report Pre Trial 2 November December 2003 Editor Anita Melander Wikman LTU SE Maria Jansson LTU SE Tony Scully LTU SE Authors Albert Alonso CSC ES Anna Lena Andersson LTU SE Staffan Andersson LTU SE Susanne Andersson LTU SE Agneta Granstr m LTU SE Monica Hansson LTU SE Peter Lems UTwente NL Stefan Roedig GScout 24 DE Barbara Vallespin CSC ES Irene Vikman LTU SE Preparation Date December 157 2003 Version Version 1 5 final Contract Start Date May 01 2002 Duration 22 months February 2004 Project co ordinator Rainer Herzog Ericsson GmbH ADD E PreTrialTwoReport_WP5_LTU_Version1 5_20040130 Contents Executive Summary Part One Field Pre Trial Details per Trial Site Testing period Location of test all locations where BAN was tested data read Person s testing BAN BAN Mobi serial number iPAQ model and extras Sensors tested parameters measured Part Two Outcome Assessment Activating iPAQ Sending Mobi iPAQ Back End system communication Sensor view on iPAQ Manual input Portilab Part Three Usability and Empowerment Functionality Ease o
10. Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 reports that it is acceptable except for the complicated manual input see above Trial owner 2 reports that Version 3 1 is quite easy to use with exception of the Manual Input which shows errors Comments from test person 1 thinks that the pulse oximeter sensor is in his way the finger feels stiff when performing activities Carrying the Mobi is ok It is easy to forget to bring the iPAQ when moving around It is sweaty on the fingertip at the end of a six hour session Comments from test person 2 would be nice with a little box for all the cables or perhaps a different construction Trial 4 Home care and remote consultation for recently released patients in a rural area This BAN is very easy to use The hourglass and the notice on the screen improved the BAN a lot Also all applications on the screen were better than in Version 3 0 30 66 Spain Trial 1 Support of home based healthcare services It is definitely not easy to use for either a professional or a patient as he she does not know when data is being stored UMTS It is not difficult to use if you have a minimum of support and have been taught how to deal with the devices Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies OK But battery c
11. PAQ Participants may wish to be outdoors for many hours Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 reported that he could be fully mobile when carrying all equipment for 8 hours and 6 hours on 27 11 and 28 11 respectively In the second phase of sessions comments from test person 1 feels a bit prevented in doing everything mainly because of the pulse oximeter sensor Wonders if there is a possibility to have an alarm indication when the connection between Mobi and iPAQ is bad nearly lost to easier remember to bring the iPAQ Comments from test person 2 avoids doing as much as he is used to during the five hour session because he is afraid of pulling the cables out of the Mobi Is not as active as he normally is Trial 4 Home care and remote consultation for recently released patients in a rural area All tested patients said that this instrument was much better than the regular ECG It is smaller and with only four sensors to apply The trial owners think that the mobility is very good because of its size and easiness 34 66 Spain Trial 1 Support of home based healthcare services The battery of the device must be full or almost The iPAQ has to be connected most of the time The mobility is then reduced Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women w
12. The screen is more improved with details and signs to show what is happening under the test The icon is easier to understand Spain Trial 1 Support of home based healthcare services Difficult to identify it is not shown in any way when data is not being correctly stored UMTS Better than in previous versions It gives you clues of where the error comes from Trial 2 Outdoor patients rehabilitation 47 66 See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies This has improved 48 66 Security Germany Trial 1 Secondary prevention in coronary heart disease Version 3 1 is much more stable than the previous one Nevertheless the whole system is not safe enough for clinical decision making The verification of the security of the system should be the aim of a larger pilot study Sweden Trial 1 The Lighthouse alarm and locator Security is not commented on Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis No comment Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency In trial owner 1 s view this is not possible to define Trial owner 2 also could not really say but test person 1 commented in general that anybody can get their hands on the data this is still the same as for Version 3 0 Dropout of data was high Trial 4 Ho
13. al input disturbs the sending from the Mobi Once the sending stopped while the manual input was in use The three sending sessions where the sign flushing data did not come up on the screen were the same sessions that the trial persons were using manual input It is difficult to use the D applications sometimes it was stuck on the screen for a long time The parameters blood pressure pulse CRP and blood glucose were no problem to use and send Spain Trial 1 Support of home based healthcare services OK No problems with the manual input Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies No problems were encountered but this was not specifically tested 25 66 Portilab Germany Trial 1 Secondary prevention in coronary heart disease There were problems with storing and reviewing data from PortiLab2 The problem could not be specified In general PortiLab2 is still not very user friendly One improvement seems to be that real time measurement is now available Sweden Trial 1 The Lighthouse alarm and locator This is still not user friendly Special UMTS trial Since the configuration file for Portilab was not correct at time of trial no detailed analysis of the data has been performed Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis I
14. al owner noted This was a great improvement in Pre Trial 2 In Pre Trial 1 you did not know if it was an error or if the BAN was working Security the system was still generally considered to need greater reliability if it were to be considered a safe system for clinical application and decision making Logging functionality there seemed to be some confusion about the meaning of the expression logging Some trial owners seem to have believed it related to log in i e start up They reported that it was easier to log in Portilab PortiLab could be accessed easily enough however it was considered to be difficult to locate and review the correct file as the file name was made up of many figures and letters It was difficult to understand how one should read the values graphs that you see in Portilab For example how does one analyse it What do the values stand for It was felt by some trial owners that more training would be required to use PortiLab effectively Greater transparency was needed In general it was felt that PortiLab was not yet user friendly enough Manual input there were minor instances of improvement there were still many steps to be taken and fields to be filled in before sending The manual input part is a bit tricky to understand which button to press for example when filling in the text field and when 65 66 changing language But the good thing in Manual Input is tha
15. ant improvement Compare this with a 10 success rate in Pre Trial 1 in August Trial owner 2 notes that it is much easier more automatic but still not perfect 37 66 Trial 4 Home care and remote consultation for recently released patients in a rural area Much better in Pre Trial 2 In one of twenty there was a startup failure A great improvement Spain Trial 1 Support of home based healthcare services Start up has been greatly improved in terms of establishment of the GPRS connection between the iPAQ and the BEsys It does not have to be manually tested if the communication has been established which means a big step forward UMTS It has been greatly improved in terms of establishment of the UMTS connection between the iPAQ and the BEsys It doesn t have to be manually tested if the communication has been established which means a big step forward Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies This is much improved 38 66 GPRS connection stability Germany Trial 1 Secondary prevention in coronary heart disease During upgrade of the BANs a problem occurred with the SIM cards which were caused by a missing HTTP chunking functionality At time of writing it was not clear if problems with sending of the data to BESys are caused by this missing functionality but it was consi
16. ber 2003 The second took place on Saturday 29 November to Sunday 30 November 2003 This consisted of three sessions Saturday SESSION 1 one hour 08 35 09 35 and SESSION 2 six hours 12 15 18 15 Sunday SESSION 3 five hours 15 15 20 15 Trial 4 Home care and remote consultation for recently released patients in a rural area 2 December 5 December 2003 6 66 Spain Trial 1 Support of home based healthcare services The testing has been performed since December 12 until J anuary 5 The testing was done periodically everyday several times at different hours The testing concerning UMTS is being performed at the moment UMTS The testing has been performed from January 10 and still going on The testing was done periodically everyday several times at different hours Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies The trial was conducted from 15 November to 9 December 2003 7 66 Location of test all locations where BAN was tested data read Germany Trial 1 Secondary prevention in coronary heart disease The trial took place at GesundheitScout24 Duisburg and the practice of Dr Metten in Monchengladbach Sweden Trial 1 The Lighthouse alarm and locator The cities of Stockholm and Lulea Special UMTS trial driving around the suburbs an
17. connection even during handover Other limited tests in Sweden also provided positive results with UMTS and in Enschede a similar experience was reported The most promising results were reported from Barcelona where a marked improvement was noted in the performance using UMTS over that recorded for GPRS The final phase of the trials will generate a final User Evaluation Report which will sum up the usability and applicability of the final version of the MobiHealth system prototype 66 66
18. coronary heart disease It still takes up to three minutes to activate the BAN The IPAQ and the Mobi have to be restarted after every measurement Starting functionality is nevertheless improved with respect to the previous version Sweden Trial 1 The Lighthouse alarm and locator No comment Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis The test person stated that it was convenient to carry the Mobi and iPAQ The equipment did not hinder the person in his job as a teacher Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency The BAN system is more stable than version 3 0 Start up is easier and more automatic On the sensor viewer the signals are of good quality Trial owner 2 cannot decide today if the data collected is possible to analyse and are of use for her in her daily work since she had not yet been able to get in to Portilab Unfortunately data collected was not possible for her to analyse from Portilab today since she did not have enough information about what the values stand for missing in the user manual and the dropout of data was high 28 66 Trial 4 Home care and remote consultation for recently released patients in a rural area This version is better to work with They could understand when the BAN was working and when it did not It was easy to understand what the next step in the process would be and they could se when the
19. d ECG sensors are too long according to test persons Trial 4 Home care and remote consultation for recently released patients in a rural area Wearability was also as good as in Pre Trial 1 Spain Trial 1 Support of home based healthcare services No problems foreseen from this point patients seem to feel comfortable with the devices in terms of wearability Trial 2 Outdoor patients rehabilitation See above 45 66 The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies No change 46 66 Visibility of errors on iPAQ Germany Trial 1 Secondary prevention in coronary heart disease The only feature here is that one can see on the iPAQ when the Bluetooth connection between the iPAQ and Mobi fails Sweden Trial 1 The Lighthouse alarm and locator This has improved Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 thinks the visibility of errors is good Trial owner 2 thinks it is better but it still does not indicate if data still is sending or if connection is lost Trial 4 Home care and remote consultation for recently released patients in a rural area This was a great improvement in Pre trial 2 In Pre trial 1 you did not know if it was an error or if the BAN was working
20. d centre of Lulea Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis The location of the test of the BAN was at the Department of Health Science Boden Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency The first pre trial took place in Stockholm Sweden The second took place in the home of the trial owner located in the city centre of Lulea The first session was in the home of the trial owner and out walking in the city centre of Lulea shopping and visiting a cafe driving a car and visiting a friend all in the city centre and finally shopping at a large shopping centre The second sessions were at the home of test person 2 situated at Lerba cken 5 km from the city centre of Lulea Trial 4 Home care and remote consultation for recently released patients in a rural area The trials were conducted at Sandens Health Care Centre Boden 8 66 Spain Trial 1 Support of home based healthcare services The BANSs were tested in the Clinic hospital in Barcelona The data was sent to the server placed in Telef nica Madrid and then the access to the information was done from portable PCs also at the hospital Barcelona This also applied to the UMTS test Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies The tes
21. data sending time Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis No comment Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 declares that a real trial will start on 6th or 7th of December but will not include predefined patients according to the primary inclusion criteria For trial owner 2 she believes it would be nice if the Manual Input worked better otherwise they will not be able to use that in the real trial Then only sending data via pulse oximeter and activity sensor will be used But she would like to be able to correlate data from the sensors with the Manual Input After viewing data in Portilab trial owner 2 was hesitant aboutusing this on real patients but perhaps it would be all right on healthier Resp patients On the other hand they could always evaluate the patients experience of carrying the BAN and if the dropout of data is high that is also an evaluation 61 66 Trial 4 Home care and remote consultation for recently released patients in a rural area The group has to know that the system is safe to use now for a final field trial with real patients If the BAN is safe then they can start the field trial as soon as possible They hope that the manual input is better in the next version that there are no problems with sending and using manual input at the same time and that they can use ID on each pe
22. dered to be very likely Sweden Trial 1 The Lighthouse alarm and locator The system still disconnects but less than before Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 says it is better but not sufficient see above Trial owner 2 says much better Didn t really have a problem with this now Trial 4 Home care and remote consultation for recently released patients in a rural area Seemed better in Pre trial 2 The system worked much faster now than in Pre trial 1 Spain Trial 1 Support of home based healthcare services The maintenance of the connection is not very stable After a few minutes of sending data the Mobi turns off and the data transmission is cut which means that the iPAQ needs to be restarted UMTS The maintenance of the connection is very stable It only breaks if the battery of the Mobi or the cell phone is low Trial 2 Outdoor patients rehabilitation 39 66 See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies This is better but still most registrations do not last longer than two hours 40 66 Batteries Germany Trial 1 Secondary prevention in coronary heart disease No changes from Pre Trial 1 Mobi batteries last for around 8 hours Again t
23. e Trial 1 instructed by the trial owner 10 66 Trial 4 Home care and remote consultation for recently released patients in a rural area Two trial owners did the testing There were ten people participating in the trial as patients A 12 lead ECG was carried out using the regular ECG at Sandens Health Care Centre on each participant before testing the BAN When the BAN was tested one or more test was done on each participant Spain Trial 1 Support of home based healthcare services There were two technicians testing the BANs and the global system plus two professionals evaluating the results and the measurements done by the sensors Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies The trial owner Dr Rik Quartero Cees Sluimer 11 66 BAN Mobi serial number iPAQ model and extras Germany Trial 1 Secondary prevention in coronary heart disease Two BANSs were tested 1 Mobi serial number 0924030053 IPAQ 4G2ADW34N07C 2 Mobie serial number 0924030050 IPAQ 4G2ADW34N082 Sweden Trial 1 The Lighthouse alarm and locator Luth 010 4g2adw34n072 Luth013 4g2adw34n06e Special UMTS trial Mobi 0924030048 MBU 4G2ADW34N06M UMTS telephone Nokia 6650 Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis iPAQ 4G2ADW34NO6E GPRS 9V36K
24. endum to the Enschede comments The test procedure in Enschede was All BANs directly Bluetoothed to PortiLab GPRS BAN tested with pregnant volunteer run time one hour maximum GPRS BAN with sleeve and GPRS BAN with Nokia tested synchronously on Rik Quartero Both drop out at one to four hour interval GPRS and UMTS tested synchronously on Rik Quartero UMTS failed because of lack of network cover GPRS four hour run time UMTS tested between UT and MST Total run time six hours UMTS and GPRS tested on in hospital patients GPRS drop out after one hour Mobi UMTS run time eight hours 127 MB data 63 66 Conclusions This pre trial proved to be in a good position to compare the experiences of Pre Trial 1 of Version 3 0 of the MobiHealth system this trial ran in summer and autumn of 2003 with those experiences of using the upgraded Version 3 1 and enhanced functionality which was tested in December of 2003 and January of 2004 Once again there was quite a lot of overlap in the experiences of the trial owners in different regions of Europe and the partners could see a great deal of commonality to the issues which had been addressed based on the requirements from Pre Trial 1 Report A few are noted below Start up trial owners reported improvement in starting up the system It was reported that the system was much easier to activate much quicker more automatic and one owner reported an 80 first time s
25. ents in a rural area Much easier to use in Pre Trial 2 More easy to understand A big improvement that ID was possible to use But in this Pre trial 2 they noticed that there was some sort of problem when they were sending and using manual input It was something they had not expected Spain Trial 1 Support of home based healthcare services OK 57 66 Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies This is OK 58 66 User manual Germany Trial 1 Secondary prevention in coronary heart disease The latest version of the user manual contains an extended section about PortiLab2 In general the manual is very helpful A translation of the user manual in German was ongoing at time of writing and was scheduled for finishing before Christmas to be used by patients Nevertheless it was to be feared that the manual overstrains the patients most of them are older than 50 years Sweden Trial 1 The Lighthouse alarm and locator The user manual is good Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis No comment Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 had not yet read the latest version of the user manual Trial owner 2 found the latest version better and much clearer excep
26. ere sent Special UMTS trial No problems after setting up the BlueTooth communication to the UMTS phone Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis Data was sending for about 1 2 hours data that was presented in PortiLab was 16 minutes long The text on the iPAQ screen was during the 1 hours MBU sending Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency In the first pre trial 10 minutes of data were sent on 27 November at 10 15 a m and 10 minutes were also sent on 27 November at 11 00 The system worked fine during those occasions No sending was possible on 28 November In the second trial sessions according to an independent observer data was sent for five hours continuously the whole session on Sunday 30 November Also on Saturday data was sent during the whole day but not continuously this needs correlation with Portilab Indication on the iPAQ was that the MBU was sending even when the Mobi had turned off spontaneously Trial 4 Home care and remote consultation for recently released patients in a rural area Three times when the device was sending the sign flushing data was missing One sending session stopped by itself during the test All of the other sending sessions were good 18 66 Spain Trial 1 Support of home based healthcare services There were still problems when sending data Many times
27. es There are problems with maintaining the connection between the Mobi and the iPAQ The Mobi often switches off after a few minutes Trial 2 Outdoor patients rehabilitation See above 53 66 The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies This still needs improvement 54 66 Portilab Germany Trial 1 Secondary prevention in coronary heart disease No data could be stored and reviewed in PortiLab2 during the last three days This could however have been caused by using default HTTP calls problems with German operator Real time display is available in Version 3 1 which is a big step forward In general this version of Portilab2 was not very user friendly Sweden Trial 1 The Lighthouse alarm and locator PortiLab is still not user friendly Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis No comment Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 had not downloaded and tested the latest version Due to a disc crash in the Dutch Back End System trial owner 2 had also not been able to check the Portilab changes Trial 4 Home care and remote consultation for recently released patients in a rural area In Pre Trial 1 they could not see the curves at all In this Pre trial 2 they were able to see the curves and work with PortiLab 2 A real
28. f use Safety Mobility Part Four Comparison to Pre Trial 1 and Extent of Fulfilment of Expectations Requests Part Five Preconditions for Further Trials Conclusions ADD E PreTrialTwoReport_WP5_LTU_Version1 5_20040130 2 66 Executive Summary This document reports on the results of the second pre trial of the MobiHealth project from the perspective of the trial owners As with the first trial a trial owner is defined as the doctor nurse physiotherapist administrator and technical provider involved in putting together and running the trial A trial is a field test of the MobiHealth Body Area Network prototypes and the necessary communications infrastructure The trials follow the guidelines outlined in Deliverable 1 4 of the project That deliverable determines the methodology used for evaluating the field trials Throughout December 2003 and January 2004 Pre Trial 2 tested Version 3 1 and other minor upgrades of the MobiHealth system prototype in trials running in Barcelona ES Moenchengladbach D Enschede NL Lulea and Boden SE It was the purpose of this pre trial to build on the work carried out in Pre Trial 1 summer and autumn of 2003 among trial owners and their clients patients care recipients in using the BAN and communications to evaluate the performance and user friendliness of the equipment and to provide data to the system providers for the final trials of the MobiHealth system in January and February
29. han before The Mobi still turns off sometimes but again fewer times than during Pre Trial 1 For reasons unknown to this trial owner data sending was limited to short periods of time several times Special UMTS trial The communication seemed stable during the whole measurement One test was performed while driving round in a car in Lulea from the Lighthouse through the city centre to Sandviksgatan the Bergn set bridge The test was not interrupted even though we were informed that the pre commercial UMTS network could have problems with handover between the base stations Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis The MOBI did not turn off at any time during the 12 hour trial The file in the BE is 1 hours but when viewing in the PortiLab one can only see 16 minutes Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency See under Sending above On 28 November several trials resulted in no communication message every time One spontaneous disconnection between Mobi and iPAQ occurred during the pre trial In the second pre trial sessions during the sessions on Saturday the Mobi turned off spontaneously 5 6 times but the message on the iPAQ was MBU sending Half of the turn offs might be due to test person 1 forgetting to bring the iPAQ with him when leaving one room and entering another During the session on Sunday there was onl
30. harging remains a pragmatic problem One is always looking for a wall plug 31 66 Safety Germany Trial 1 Secondary prevention in coronary heart disease Medical treatment of the patients during pre trial and real trial is not based on the transmitted vital signs because the BAN system is in a testing phase In this stage the monitoring of the ECG and blood pressure is an additional service for the patient and not a surrogate for treatment by the physician Nevertheless transmitted ECG levels seem to be valid on the IPAQ viewer and there are no artefacts if the sensors fit properly Sweden Trial 1 The Lighthouse alarm and locator It is still considered not to be a safe system for care purposes Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis The system is not stable Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 believes this has to be defined Trial owner 2 comments that the Mobi still turns off spontaneously which means that the test person has to check if the Mobi is still on There is no indication on the iPAQ that the Mobi turned off drop out of data The iPAQ still says MBU sending Comments from test person 1 is it possible for anybody to see the data on its way in cyberspace If my saturation is low will somebody come and help me Trial owner 2 thought she had sent data for longer periods than she ac
31. he battery of the iPAQ has to be almost full otherwise no measurements can be done Sweden Trial 1 The Lighthouse alarm and locator Battery lifetime is not very long Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency It was not possible for trial owner to comment Trial owner 2 notes that there is still too short a duration for the batteries in the iPAQ if the test person wants to be outside Trial 4 Home care and remote consultation for recently released patients in a rural area There were no problems with the battery in Pre trial 2 The group speculates that they may have been better prepared with batteries this time Spain Trial 1 Support of home based healthcare services Still the batteries need to be almost full to have a more or less stable connection if not the chances of error are increased Trial 2 Outdoor patients rehabilitation See above 41 66 The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies No change 42 66 Mobility Germany Trial 1 Secondary prevention in coronary heart disease Mobility is guaranteed like it was in Pre Trial 1 Sweden Trial 1 The Lighthouse alarm and locator The iPAQ and GPRS device are still a bit heavy but otherwise this is OK Trial 2 Phy
32. improvement in this version Spain Trial 1 Support of home based healthcare services From the point of view of the user no big improvements have been performed There are still the same problems in usability and reliability 55 66 Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies Without expert help around the corner this would have been a major problem the trial owner was in Enschede where experts on PortiLab were close by 56 66 Manual input Germany Trial 1 Secondary prevention in coronary heart disease Not tested Sweden Trial 1 The Lighthouse alarm and locator The whole text was still not visible on the display Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis No comment Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 said it functions but is not convenient for the RespInsuff trial see above Trial owner 2 says that it is better in terms of being more automatic with the send button but still not optimal She could not really use it because of errors It was not good to have fields that you have to fill in every time you are going to fill in an activity There are still too many steps to remember Trial 4 Home care and remote consultation for recently released pati
33. ith high risk pregnancies This is OK except for the charging issue Also there are too many leads and too long 35 66 36 66 Part Four Comparison to Pre Trial 1 and Extent of Fulfilment of Expectations Requests With regard to Pre Trial 2 please provide any details of the extent to which your expectations for improvements to Version 3 1 of the BAN were fulfilled Please compare Version 3 1 and Version 3 0 with regard to the performance usability safety functionality and problems encountered in terms of Start up function Germany Trial 1 Secondary prevention in coronary heart disease One of the largest improvements of the Version 3 1 is the advanced start up functionality It is not that cumbersome anymore to start the iPAQ by inserting the GPRS jacket at the right moment etc Sweden Trial 1 The Lighthouse alarm and locator This has now improved over Version 3 0 Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis Starting up the system is much quicker than Pre Trial 1 It is easy to use the manual input The system is a little bit more stable than Pre Trail 1 but not enough to use in the healthcare system The trial owner needs more knowledge to analyze the signals in PortiLab before she can say anything about that Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 reports an 80 success rate now a signific
34. l only and was run exclusively in the hospital and between the hospital and the telecommunications services Two technicians tested the system and two professionals evaluated the outcomes and measurements 4 66 Trial 2 Outdoor patients rehabilitation In the scenario description for the trials as originally designed the patients involved in this trial are chronic respiratory patients who could benefit from rehabilitation programmes to improve their functional status The study aims to check feasibility of remotely supervised outdoors training programs based on control of walking speed enabled by use of the BAN The physiotherapist will receive on line information on patient s exercise performance and will provide feedback and advice In this pre trial exclusively technical and medical personnel tested the system and the test was run in the hospital and between the hospital and the telecommunications service partner The procedure was similar to the other Barcelona trial The Netherlands Trial 1 Tele Trauma Team This trial is for a sensor visual and transmission system for trauma medical care delivered by an ambulance at the scene or on the way to the hospital The main objectives are to examine the feasibility and safety of monitoring various vital signs recording the site of the accident and communicating with and guiding the paramedics all by sensors put by a paramedic upon the patient or worn by himself and relaying these
35. ld read the values graphs that you see in Portilab For example how does one analyse it What do the values stand for For example in manual input is it which second the activity etc happened Again she did not find out this by reading the user manual Trial owner 2 did not have a chance to use Portilab when collecting data since there was no configuration file Trial 4 Home care and remote consultation for recently released patients in a rural area This group has worked with PortiLab and has seen the curves etc However they feel the need for more training to understand and use PortiLab and be more comfortable with the system Spain Trial 1 Support of home based healthcare services There are still the same problems with respect to the usability of the PortiLab from the professional point of view There have been few changes with respect to the previous version Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies With a little help from my friends it works All but intuitive 27 66 Part Three Usability and empowerment Please provide an assessment of the performance of the current prototype Version 3 1 of the BAN system and communications that you tested in this these pre trial s according to the following factors Functionality Germany Trial 1 Secondary prevention in
36. me care and remote consultation for recently released patients in a rural area For the first time the group has seen curves under the testing period on PortiLab2 now in Pre trial 2 Other than that they cannot comment on security Spain Trial 1 Support of home based healthcare services Same situation as with the previous version It is not secure enough to do clinical trials 49 66 Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies This is OK 50 66 Logging functionality Germany Trial 1 Secondary prevention in coronary heart disease No comments were made Sweden Trial 1 The Lighthouse alarm and locator The logging functionality has improved over Version 3 0 Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis No comment Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency For trial owner 1 the logging functionality was easier Trial owner 2 did not provide a comment not being sure of the meaning of the question Trial 4 Home care and remote consultation for recently released patients in a rural area Logging functionality was the same in Pre Trial 2 as in Pre Trial 1 Spain Trial 1 Support of home based healthcare services The fact of not having to manually test the establishmen
37. mplexity Unfortunately it was not possible to specify only the activity because at each time a new activity is put in on the iPAQ you have to go through all fields for spirometry parameters step length FEV1 FVC PEF before sending In the second pre trials during the first session the manual input worked fine In the beginning of session 2 the language was changed from English to Swedish After this the error empty message started to pop up When changing back the language to English there was a problem in starting up the MH application again Trial owner 2 changed batteries in the Mobi reset and could after that use the manual input on and off sometimes there was an error message During session 3 Sunday it was not possible to use the manual input because the error empty message popped up again It was not easy to find out where to change language first after reading the English manual on the webpage she found out She reports that it would be good if there werent any fields that you have to fill in before choosing an activity The manual input part is a bit tricky to understand which button to press for example when filling in the text field and when changing language But the good thing in Manual Input is that there now is a Send button when choosing activity 24 66 Trial 4 Home care and remote consultation for recently released patients in a rural area Manual input is a real problem It seems that using manu
38. n off GPRS Trial 4 Home care and remote consultation for recently released patients in a rural area When activating the iPAQ a reset was performed before each test Only once was there a start up failure the remaining twenty times start up was fine Spain Trial 1 Support of home based healthcare services More stable than previous version the establishment of the GPRS connection doesn t usually fail if the battery is charged enough UMTS Much more stable than GPRS In fact UMTS never fails when stablishing the connection Very reliable Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies No problems were encountered except on MST 008 where accidentally Version 3 1 1 had been installed The sensor viewer crashed Activating UMTS was faster than GPRS The system was sufficiently intuitive not to need the manual 17 66 Sending Germany Trial 1 Secondary prevention in coronary heart disease It takes about half a minute to get the Bluetooth connection between the Mobi and IPAQ The connection and the sending of the data is then stable Measurement breaks down after 30 60 minutes Still the Mobi turns off from time to time without any reason Sweden Trial 1 The Lighthouse alarm and locator The sending period was short during many of the tests only 2 5 minutes of data w
39. network was working The BAN feels very stable Spain Trial 1 Support of home based healthcare services Not very user friendly GPRS establishment has been greatly improved but still the percentage of data storage at the BEsys is pretty low UMTS Much more friendly than GPRS connection is greatly improved and the data is stored correctly at the BEsys Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies Functionality is good much improved compared to the earlier version But direct Bluetooth connection between the Mobi and latest PortiLab version appeared impossible with all tested Mobis 29 66 Ease of use Germany Trial 1 Secondary prevention in coronary heart disease After a little training it is no problem for a patient or another test person to put on the sensors on his her own Sensor stickers never got loose during testing Removal of ECG sensors can be painful Wearing of the BAN is convenient and does not affect activities of daily living Sweden Trial 1 The Lighthouse alarm and locator There are still too many steps to carry out Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis If things go well a connection between all the equipment is made the first time on start up and then the equipment is relatively easy to use Trial 3
40. nsor viewer on the iPAQ shows the signals correctly but with no scale or axis There are no changes with respect to the previous version The results presented in the iPAQ do not permit a correct interpretation The display of numerical results is satisfactory but the graphics are useless since no scale is available The professional cannot base his her whole evaluation on this information As a conclusion this trial owner must say that the interaction with the iPAQ should be much more simple stable and user friendly Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies This was adequate except for instability on the unit with Version 3 1 1 23 66 Manual input Germany Trial 1 Secondary prevention in coronary heart disease This was not yet tested Sweden Trial 1 The Lighthouse alarm and locator It was not possible to see the whole text in the iPAQ window Special UMTS trial no extensively tested Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis First the ID must be filled in then it is easier than Pre Trial 1 To fill in ID should be in the login function not in the manual input Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Only two manual inputs were performed in the first pre trial This is because of the co
41. rson Also they need some education in PortiLab2 or some help while doing the trial and also working with PortiLab2 Spain Trial 1 Support of home based healthcare services GPRS It would be necessary to have a stable connection between the iPAQ and the Mobi which means that the Mobi should not switch off after a few minutes as was happening during this pre trial GPRS The transmission of the data to the BEsys should be more stable it often fails and not data is stored what means that a session has to be repeated several times to have results Problems and improvements come from the visualisation part involving both the sensor viewer and the Portilab In reference to the PortiLab the interface should be improved from the clinical point of view The graphics should appear with axis in order to be evaluated The problem of selecting a patient by his name still persists It is difficult from the point of view of the professional to select a session based on a 12 digit code Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies The major issue to improve upon apart from PortiLab is the stability of the system For the primary MobiHealth target the current stability will do 62 66 marginally To get a real view of the clinical potential running times of eight hours at least are preferable Add
42. sical activity and impediments to activity in women with Rheumatoid Arthritis Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 says mobility is similar to Pre Trial 1 and sufficient Trial owner 2 agrees that it is the same Trial 4 Home care and remote consultation for recently released patients in a rural area Mobility was goos as good as it had been in Pre Trial 1 Spain Trial 1 Support of home based healthcare services Mobility is reduced due to the fact that the iPAQ needs to be charged periodically Trial 2 Outdoor patients rehabilitation See above 43 66 The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies No change 44 66 Wearability Germany Trial 1 Secondary prevention in coronary heart disease Sensors and BAN are easy to wear Length of cables is appropriate whilst doing daily activities Sweden Trial 1 The Lighthouse alarm and locator Wearability is fine Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner believes wearability is similar to Pre Trial 1 and sufficient Trial owner 2 believes that the pulse oximeter is still the sensor that does not feel 100 ok and the cables in both the pulse oximeter sensor an
43. sion of the trial owner Trial 4 Home care and remote consultation for recently released patients in a rural area The end goal of this trial is to find a way to communicate vital signs from a person at home to an Registered Nurse and or a physician for consultation and diagnosis in order to reduce visits to the hospital and give trustful and safe care at home A subsequent aim is to use this methodology and evaluate the consequences in terms of experiences of healthcare and living at home with severe illness quality of life ethical considerations etc and also evaluate the consequences for the Nurse Aids Licensed Practitional Nurses and Registered Nurses in their work In this pre trial two professionals tested the system in several different environments at home in a healthcare department and in a car driving over a wide rural area Subsequently the system was tested including 12 lead ECG by ten volunteer subjects at Sanden Health Care Centre in Boden with a further back up test for each subject This trial also explored the possibilities with regard to UMTS Spain Trial 1 Support of home based healthcare services The end resulting trial involves use of GPRS for supporting home based care for elderly chronically ill patients usually suffering from more than two concurrent conditions The MobiHealth Nurse BAN will be used to perform patient measurements during nurse home visiting This pre trial involved technical and medical personne
44. t This was acceptable for the trial but not for a commercialisation Sweden Trial 1 The Lighthouse alarm and locator Activating the iPAQ was OK one time 2 Mobis were together in the iPAQ that the trial owner had already switched on to test at the same time as she was starting another BAN while this was happening she was not touching the other iPAQ When she looked at it there were 2 Mobis noted and the display said checking connections She exited and noted that the presence of the other Mobi disappeared and Mobi is sending was displayed on the IPAQ Special UMTS trial OK after resetting the iPAQ Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis The professional had to fill in login and password on the iPAQ every single time it was started up Compared with Pre Trial 1 it was much easier to activate the iPAQ It takes about 2 3 min from login to MBU sending Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency In the first pre trial the Mobi iPAQ communication came on at start up Success rate was 80 20 of the time the check mobi message appeared 16 66 In the second when starting up all of the three sessions the trial owner had to reset the iPAQ 2 times in every session before reaching MBU sending status It was still necessary to fill in a password after every restart reset It was sometimes a bit difficult to reset tur
45. t from the part about Portilab She felt there has to be much more explanation for the users about how to use the graphs data values that you can see in Portilab We have graphs so what do they really say How does one analyse Trial 4 Home care and remote consultation for recently released patients in a rural area The user manual has always been very good and important to use for doing the pre trials Spain Trial 1 Support of home based healthcare services No comment 59 66 Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies For the BAN no manual was needed For PortiLab it does not help a lot 60 66 Part Five Preconditions for Further Trials Please indicate the conditions for development of the BAN system and communications or any relevant factors that you consider will be necessary in order to carry out an effective final field trial with valid conclusions Germany Trial 1 Secondary prevention in coronary heart disease Improvements in PortiLab2 which allow the trouble free storing and reviewing of the data It is till now not clear if these problems are caused by the problems with Vodafone Germany and the downgrade of the sample rate to 128 samples sec Sweden Trial 1 The Lighthouse alarm and locator We still need fewer disconnections in the system and longer
46. t is easy to go to the PortiLab application There is a problem finding the file when the file name is figures and letters One has to auto scale every parameter this is not good For this trial owner the signals are of good quality but a problem is that one does not know if they are valid Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency Trial owner 1 had not yet downloaded and tested the latest version For trial owner 2 support was needed when installing Portilab and when viewing the data support was given by phone According to Portilab there were a total of 8 files from her Pre Trial 2 Saturday and Sunday together The longest file appeared to be 5 hours long but when looking at it in Portilab only 14 41 min are viewable in the Portilab a dropout of 4 hours and 45 min This was similar with most of the files The longest file is around 45 min as far as can be seen so the total dropout of data is quite high Trial owner 2 can see that she only managed to send manual input on two occasions first session and in the beginning of the second but there are some drop alarms One very important question is whether the saturation is missing in Portilab or in the configuration file for respinsuff or if the trial owner just did not understand how it was presented She could not find this out by reading the user manual 26 66 Trial owner 2 also thought it was difficult to understand how one shou
47. t of GPRS and UMTS connection is a great improvement in comparison to the previous version Trial 2 Outdoor patients rehabilitation See above 51 66 The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies This is OK 52 66 General stability issues Germany Trial 1 Secondary prevention in coronary heart disease Measurements break down after 30 60 minutes but this is really a large improvement if compared with Version 3 0 Sweden Trial 1 The Lighthouse alarm and locator In general this is now better but still not perfect Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis No comment Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency For trial owner 1 the stability overall was better Trial owner 2 agreed that the system is more stable than Version 3 0 Also test person 1 who had tested the earlier version had this impression Trial 4 Home care and remote consultation for recently released patients in a rural area The BAN feels more stable in Pre Trial 2 The group got an answer every time they made some notes or sent something on the iPAQ They felt that they could follow the process from measurements to sending and to the BE system much more in Pre trial 2 than they could in Pre trial 1 Spain Trial 1 Support of home based healthcare servic
48. t there now is a Send button when choosing activity User manual this was a great improvement Translations had been made locally and the overall manual was considered to be very helpful indeed An exception for one trial owner was the section on PortiLab where it was requested that there has to be much more explanation for the users about how to use the graphs data values that you see in PortiLab In summary this pre trial revealed a great improvements over the previous version of the MobiHealth system in the areas of start up and user manual b moderate improvements to GPRS connection stability and display of errors on the iPAQ and c some minor improvements to the sensor viewer The pre conditions for carrying out the next phase of trials as stated by the trial owners in the Pre Trial 1 Report were generally answered in the technical delivery of the upgrade while some elements left room for improvement The critical areas which the trial owners perceived to need further improvement were greater connection stability longer run time in sending data and the usability of PortiLab and readability of the data stored there A note on connectivity the bulk of the comments from the users regarding incidents of connection breakdown related to the use of GPRS The use of UMTS in this pre trial was limited but a test of the UMTS system was carried out at the Lighthouse and its environs with positive results on stability and
49. ts were conducted at MST in Enschede also on the UT Campus driving around Enschede and in the town of Boekelo 9 66 Person s testing BAN Germany Trial 1 Secondary prevention in coronary heart disease Baerbel Krell Cardiologist Rien Metten Cardiologist Norbert Fischer Patient Anna Lenzen Patient Christian Hund Technician Stefan Roedig Coordinator Sweden Trial 1 The Lighthouse alarm and locator Anna Lena Andersson trial owner Director of Lighthouse Care Centre Maria Porsberger care personnel Eeva Kaisa Nilsson care personnel Anders Granstr m independent test person CEO of Centre for Distance Spanning healthcare and Stefan Kullberg medical technology consultant Special UMTS trial Erik Bertilsson no ECG sensors applied Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis One professional person tested the BAN with a test person at the Department of Health Science Trial 3 Monitoring of vital parameters in patients with respiratory insufficiency In the first test the test subject was Staffan Andersson the doctor in charge of this trial In the second Susanne Andersson the trial owner wore the BAN for one hour Then test person 1 the trial owner s partner wore it for six hours as in Pre Trial 1 instructed by the trial owner Then test person 2 the trial owner s father wore it for five hours this had not happened in Pr
50. tually did as she could see in Portilab afterwards Trial 4 Home care and remote consultation for recently released patients in a rural area This group wished to reserve answering the safety question until they could hear the opinion of the consulting doctor on the validity of the readings 32 66 Spain Trial 1 Support of home based healthcare services As the system often fails when sending the data to the BEsys it is considered not safe enough for clinical use UMTS As the system doesn t allow an interpretation of the results it is considered not safe enough for clinical use Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies There are no complaints 33 66 Mobility Germany Trial 1 Secondary prevention in coronary heart disease Mobility was guaranteed during the pre trials patients and testing persons walked around taking the IPAQs with them Distance to the iPAQ can be up to 10 meters If the distance is more there are first artefacts and then measurement breaks down Sweden Trial 1 The Lighthouse alarm and locator The iPAQ and GPRS device are still a little heavy Trial 2 Physical activity and impediments to activity in women with Rheumatoid Arthritis To get full mobility in this pre trial the critical factor is the battery consumption in the i
51. uccess rate compared with 10 in Pre Trial 1 Minor failures to start up were solved by simply repeating the process and resetting the iPAQ GPRS connection stability trial owners noted a greater stability and fewer incidents of break off in connection when compared with Pre Trial 1 With regard to the data transfer there was quite a spectrum of experiences here Connections were indicated on the iPAQ to last anywhere between 30 minutes and five hours however at the back end much smaller time values for data transfer were indicated For example in one case data was sending for 1 1 2 hours data that was presented in PortiLab was 16 minutes UMTS connection stability the use of UMTS in this pre trial was limited but a test of the UMTS system was carried out at the Lighthouse and its environs with positive results on stability and connection even during handover Other limited tests in Sweden also provided positive results with UMTS and in Enschede a similar experience was reported The most promising results were reported from Barcelona where a marked improvement was noted in the performance using UMTS over that recorded for GPRS Sensor viewer again there were reports of improvement with the sensor viewer Some trial owners expressed the wish for a scale in order to better determine the readings visually The display of numerical results is satisfactory but the graphics are useless since no scale is available
52. y one turn off after five hours when the session was about to end The test persons were asked to keep an eye on the Mobi to see that it did not turn off There was connection to the Back End System in all sessions There were some resets of the iPAQ during start up procedure in all sessions 20 66 Trial 4 Home care and remote consultation for recently released patients in a rural area Checking with the Back End System there are valid signals on several files from the Remote Consultation BAN The consulting doctor is to provide an opinion on the standards and safety in sending from the BAN to the Back End System Spain Trial 1 Support of home based healthcare services The communication between the iPAQ and the server when establishing the GPRS connection is OK The communication between the Mobi and the iPAQ is complicated because the Mobi turns off after a few minutes of having been switched on The communication between the iPAQ and the BEsys when sending data often fails and no data is stored in the BEsys UMTS Very easy to stablish the connection between the three devices and it always works properly Trial 2 Outdoor patients rehabilitation See above The Netherlands Trial 1 Tele Trauma Team and Trial 2 Integrated home care for women with high risk pregnancies No problems were encountered 21 66 Sensor view on iPAQ Germany Trial 1 Secondary prevention in coronary heart disease
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