Pilot-scale, Randomized Study Comparing Self-monitoring of Weight and Blood Pressure Via an Electronic Health Journal (patientMpower Platform) With Usual Care in Haemodialysis Patients
Phase: NA
Conditions: Renal Dialysis
Sponsor: patientMpower Ltd.

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A pilot-scale, randomized study comparing 
self-monitoring of weight and blood pressure via an 
electronic health journal (patientMpower platform) with 
usual care in haemodialysis patients 
 
 
Renal Dialysis patientMpower 02 
 
Draft protocol date: 20 December 2018 
 
Number of pages: 42 
 
Version 2.0 
 
Authors: 
 
Principal investigator:  
Dr. Conall O’Seaghdha, Beaumont Hospital, Dublin 9, Ireland. 
 
Co-investigators:  
Colin Edwards, Eamonn Costello, patientMpower Ltd., Digital Depot, Thomas 
St., Dublin D08 TCV4, Ireland. 
 
Dr. Donal Sexton, Beaumont Hospital, Dublin 9, Ireland. 
 
www.clinicaltrials.gov NCT 03403491  
 
 
 
Conﬁdential 

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Renal dialysis patientMpower 02
Version 2.0, 20 Dec 2018 
Table of Contents 
PROTOCOL SUMMARY
4 
FLOW CHARTS
7 
Flow chart 1:
Patient recruitment process
7 
Flow chart 2
Assessments during observation period
9 
List of Figures
13 
List of Abbreviations
15 
1. 
Introduction
16 
1.1 
Medical background
16 
1.2 
Product proﬁle
16 
2.
Rationale, objectives and beneﬁt-risk assessment
17 
2.1 
Rationale for performing the trial
17 
2.2 
Trial objectives
18 
2.3 
Beneﬁt-risk assessment
19 
3. 
Description of design and trial population
19 
3.1 
Overall design and plan
19 
Figure 3.1: 1
Diagram of trial design
20 
3.1.1 
Administrative structure of trial
20 
3.2 
Discussion of trial design, including choice of control group
20 
3.3 
Selection of trial population
21 
3.3.1 
Main diagnosis for study entry
21 
3.3.2 
Inclusion criteria
21 
3.3.3 
Exclusion criteria
22 
3.3.4 
Removal of patients from therapy or assessments
22 
4. 
Study observational intervention
22 
4.1 
Observational intervention to be assessed
23 
4.1.1 
Identity of observational intervention and comparator(s)
23 
4.1.2 
Method of assigning patients to observational groups
23 
4.1.3 
Blinding and procedures for unblinding
24 
4.2 
Concomitant therapy, restrictions and rescue treatment
24 
4.2.1 
Rescue medication, emergency procedures and additional treatment
24 
4.2.2 
Restrictions
24 
4.3 
Treatment compliance
25 
5 
Variables and their assessment
25 
5.1 
Eﬃcacy
25 
5.1.1 
Eﬃcacy endpoints
25 
5.1.2 
Assessment of eﬃcacy
27 
5.2 
Safety
28 
5.3. 
Other variables
28 
5.4 
Appropriateness of measurements
28 
6
Investigational plan
28 
6.1 
Visit schedule
29 
6.2 
Details of trial procedures at selected visits
29 
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6.2.1 
Patient recruitment process
29 
Figure 6.2.1: 1 Patient recruitment process:
30 
6.2.2
 Assessments during observation period
31 
7. 
Statistical methods and determination of sample size
35 
7.1 
Statistical design and model
35 
7.2 
Null and alternative hypotheses
35 
7.3 
Planned analyses
35 
7.3.1 
Primary analyses
37 
7.3.2 
Secondary analyses
37 
7.3.3 
Safety analyses
37 
7.3.4 
Interim analyses
37 
7.3.5 
Health economic analyses
38 
7.4 
Handling of missing data
38 
7.5. 
Randomisation
38 
7.6 
Determination of sample size
38 
8. 
Informed consent, data protection and trial records
38 
8.1 
Study approval, patient information and informed consent
38 
8.2 
Data quality assurance
39 
8.3 
Records
39 
8.3.1 
Source documents
39 
8.3.2 
Direct access to source data and documents
39 
8.3.3 
Storage of records
39 
8.4 
Statement of conﬁdentiality
39 
8.5 
Completion of trial
40 
8.6 
Protocol violations
40 
8.7 
Compensation available to the patient in the event of study-related 
injury 40 
9
References
41 
10.
Appendices
41 
Appendix 10.1
Cointerventions protocol
41 
Appendix 10.2
Contamination protocol
41 
Appendix 10.3
Steering committee
41 
Appendix 10.4
Adjudication committee
41 
Appendix 10.5
Recruitment of patients
42 
Appendix 10.6
Training of personnel
42 
Appendix 10.7
Trial registration on public registry
42 
Appendix 10.8
Funding
42 
Appendix 10.9
Incentives for participation:
42 
 
 
 
 
Conﬁdential 
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PROTOCOL SUMMARY 
 
PRODUCT 
patientMpower app (+ digital 
weighing scales & blood pressure 
monitor) 
CLINICALTRIALS.GOV IDENTIFIER 
NCT  03403491 
PROTOCOL TITLE 
A pilot-scale, crossover randomized 
study comparing self-monitoring of 
weight and blood pressure via an 
electronic health journal 
(patientMpower platform) with usual 
care in haemodialysis patients 
CO-ORDINATING INVESTIGATOR 
Dr. C. O’Seaghdha, Beaumont 
Hospital, Beaumont Road, Dublin 9, 
Ireland 
NUMBER OF TRIAL SITES 
Three (dialysis sites under the 
governance of Beaumont Hospital): 
●
Beaumont Hospital dialysis 
center 
●
Beacon Drogheda Dialysis 
Unit 
●
Northern Cross Dialysis Unit 
STUDY OBJECTIVES 
To assess the eﬀect of 
self-monitoring using the 
patientMpower app [+digital 
weighing scales & blood pressure 
(BP) monitor] on outcomes in 
ambulatory haemodialysis patients. 
METHODOLOGY 
Prospective, run-in period followed 
by open-label, randomized, 
two-period cross-over comparison 
of patientMpower app (+digital 
weighing scales & BP monitor) 
versus sham electronic app (no 
scales or BP monitor). 
Usual care for all patients 
throughout study. 
NUMBER OF SUBJECTS 
Total randomised: 50 
●
patientMpower app followed 
by sham application: 25 
●
sham application followed by 
patientMpower app: 25 
DIAGNOSIS  
End Stage Kidney Disease requiring 
regular ongoing haemodialysis  
 
Conﬁdential 
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Renal dialysis patientMpower 02
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MAIN CRITERIA FOR INCLUSION 
Age ≥18 years, owns a smartphone 
or tablet device, has an email 
address, internet access at home, 
demonstrated understanding of use 
of patientMpower app, weighing 
scales and BP monitor, written 
informed consent 
TEST PRODUCT 
patientMpower app (electronic 
health journal) + digital weighing 
scales + BP monitor used daily 
COMPARATOR PRODUCT 
Sham electronic health journal 
without linkage to digital weighing 
scales or BP monitor, and without 
receiving prompts or alerts. 
END OF STUDY DEFINITION 
10 weeks 
PRIMARY ENDPOINT 
Frequency of use of the 
patientMpower app.  
SECONDARY ENDPOINTS 
Eﬀect of patientMpower app 
(+digital weighing scales & BP 
monitor) on 
●
total ﬂuid removed by dialysis 
during the patientMpower 
observation period 
●
proportion of haemodialysis 
sessions in which 
ultraﬁltration rate is ≤ 10 
mL/kg/h. 
●
proportion of haemodialysis 
sessions in which interdialytic 
weight gain (IDWG) is ≤ 4%. 
●
pre-dialysis weight. 
●
pre-dialysis BP 
●
medication adherence. 
●
compliance with daily 
recording of ﬂuid intake, 
weight, and BP. 
●
requirement for additional 
unscheduled dialysis or 
isolated ultraﬁltration 
sessions. 
●
inferior vena cava diameter 
(optional measure) 
Patient-reported symptoms will also 
be recorded on the app. 
  
Conﬁdential 
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INTERIM ANALYSIS 
None planned 
STATISTICAL METHODS 
●
Descriptive statistics tables 
will be prepared 
●
Repeated measures mixed 
eﬀects models will also be 
used to compare groups in 
terms of both categorical and 
continuous outcomes.  
 
 
Conﬁdential 
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FLOW CHARTS 
 
Flow chart 1:
Patient recruitment process 
 
Step 
Day 
Action 
1 
- 30 to -7 
Study centre publicises the study to potential 
participants, i.e. the entire cohort of patients on 
maintenance haemodialysis at Beaumont Hospital. 
This interaction will be performed by research staﬀ 
and not by the physicians looking after the medical 
care of the potential participants.  
Potential participants will advise research staﬀ of 
their interest in taking part.  
2 
0 
(Baseline) 
At planned usual care haemodialysis visit to study 
centre, the study will be discussed (face-to-face) with 
potential participants who have expressed an interest 
in taking part. 
Patients will give written informed consent before any 
study-speciﬁc actions A . 
Usual care run-in period starts. 
Randomisation to either of two possible observation 
sequences B  is allocated on or after start of run-in 
period. 
3 
0 
(Baseline) 
Research team advises patientMpower that the 
patient has started the study and of the allocated 
group.  
4 
11 to 14 
patientMpower provides information/help (includes 
instructions on installation of patientMpower app or 
sham application to patient at the planned date of 
2-week usual care haemodialysis visit to study 
centre A  .  
If ﬁrst period is patientMpower app, digital weighing 
scales and BP monitor will also be provided to the 
patient at this time.  
5 
14 (start of 
period 1) 
Patient starts using patientMpower app or sham 
application (dependent on randomized allocation) 
 
A  A paper version of the full-length patient information document will be given 
to the patient. 
 
B  The two possible observation sequences are  either patientMpower app + 
digital weighing scales + BP monitor in period 1 followed by sham application 
in period 2  or sham application in period 1 followed by patientMpower app + 
Conﬁdential 
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digital weighing scales + BP monitor in period 2. Randomised allocation will 
be done by contacting an independent randomization service. 
 
C  patientMpower Ltd will help the patient with installation of patientMpower 
application and set-up of digital weighing scales and BP monitor (so that 
patientMpower application and equipment are installed and operating at the 
start of the patientMpower observation period). 
 
 
 
Conﬁdential 
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Flow chart 2
Assessments during observation period 
 
If allocated to observation sequence 1: 
 
 
Run-in 
(usual 
care for 
2 weeks) 
Randomised observation (2 x 4 weeks) 
Sequence 1 
 
Period 1: patientMpower. Period 2: sham 
 
 
Baseline 
clinic 
visit 
Week 2 
clinic 
visit 
Daily 
(patient 
reported) 
At each 
dialysis 
session 
Week 6 
clinic 
visit 
Week 10 
Informed consent 
X 
 
 
 
 
 
Demographic data 
(include dialysis & 
medicines history) 
X 
 
 
 
 
 
Vital signs, body 
weight, IDWG at 
clinic 
X 
X 
 
X 
X 
 
Ultraﬁltration rate 
X 
X 
 
X 
X 
 
Randomisation 
X A 
 
 
 
 
 
A Start patientMpower 
(+ digital weighing 
scales & BP monitor) 
 
X 
 
 
 
 
Patient training on 
app 
 
X 
 
 
 
 
Patient-reported 
body weight, BP, 
ﬂuid intake (daily) B 
 
 
X B 
 
 
 
Patient-reported 
symptoms C 
X 
X 
X C 
 
X 
X 
Patient-reported 
compliance or 
changes (relevant 
medicines) D 
 
 
X D 
 
 
 
Stop patientMpower 
app 
 
 
 
 
X 
 
Utility & acceptability 
of patientMpower 
app E 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Start sham 
application 
 
 
 
 
X 
 
Measure inferior vena 
cava diameter F 
 
X 
 
 
X 
X 
Clinic-reported 
outcomes (e.g. 
 
 
 
 
X 
X 
Conﬁdential 
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unscheduled 
additional dialysis) 
End of study 
 
 
 
 
 
X 
 
A  Randomisation will be after informed consent and before start of Period 1. 
During Period 1, patients will use the patientMpower app (+digital weighing 
scales + BP monitor) for approximately four weeks, At the end of period 1, 
the app will be changed to the sham application (without weighing scales or 
BP monitor) and the patientMpower app will be deactivated. Patients will use 
the sham application for approximately four weeks. During the sham period, 
the connection between the BP monitor and weight scales will be disabled 
and the alerts will not be sent by the application.  
 
B  Fluid intake, weight, BP to be recorded by patient daily. 
 
C  Patient-reported symptoms include dyspnea, cramps, orthopnea, fatigue, 
depression, oedema, fatigue, itch. These symptoms are known to be related 
to ﬂuid overload and to end stage kidney disease. 
 
D  Medicines compliance reported on patientMpower app daily. 
  
E  Patient and healthcare professionals’ opinions of the patientMpower app 
sought by questionnaire. 
 
F  Measurement of inferior vena cava (IVC) diameter is optional. A separate 
informed consent will be sought for permission to measure IVC. Patients can 
choose to participate in the study without measurement of IVC.  
 
 
Conﬁdential 
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Renal dialysis patientMpower 02
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If allocated to observation sequence 2: 
 
 
Run-in 
(usual 
care for 
2 weeks) 
Randomised observation (2 x 4 weeks) 
 
Sequence 2 
 
Period 1: sham. Period 2: patientMpower 
 
 
Baseline 
clinic 
visit 
Week 2 
clinic 
visit 
Week 6 
clinic 
visit 
Daily 
(patient 
reported) 
At each 
dialysis 
session 
Week 10 
Informed consent 
X 
 
 
 
 
 
Demographic data 
(include dialysis & 
medicines history) 
X 
 
 
 
 
 
Vital signs, body 
weight, IDWG at 
clinic 
X 
X 
X 
X 
 
X 
Ultraﬁltration rate 
X 
X 
X 
X 
 
X 
Randomisation 
X A 
 
 
 
 
 
Start sham 
application 
 
X 
 
 
 
 
A Start 
patientMpower (+ 
digital weighing 
scales & BP 
monitor) 
 
 
 
X A 
 
 
Patient training on 
app 
 
 
 
X 
 
 
Patient-reported 
body weight, BP, 
ﬂuid intake (daily) B 
 
 
 
X B 
 
 
Patient-reported 
symptoms C 
X 
 
X 
X C 
X 
X 
Patient-reported 
compliance or 
changes (relevant 
medicines) D 
 
 
 
X D 
 
 
Stop 
patientMpower 
app 
 
 
 
 
 
X 
Utility & 
acceptability of 
patientMpower 
app E 
 
 
 
 
 
X 
Measure inferior 
vena cava 
diameter F 
 
X 
 
 
X 
X 
Conﬁdential 
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Clinic-reported 
outcomes (e.g. 
unscheduled 
additional dialysis) 
 
 
X 
 
 
X 
End of study 
 
 
 
 
 
X 
 
A  Randomisation will be after informed consent and before the start of Period 
1. During Period 1, patients will use the sham application (without weighing 
scales or BP monitor) for approximately four weeks, At the end of period 1, 
the app will be changed to the active patientMpower app (+digital weighing 
scales + BP monitor). Patients will use the active patientMpower app (+digital 
weighing scales + BP monitor) for approximately four weeks. During the 
sham period, the connection between the BP monitor and weight scales will 
be disabled and the alerts will not be sent by the application.  
 
B  Fluid intake, weight, BP to be recorded by patient daily. 
 
C  Patient-reported symptoms include dyspnea, cramps, orthopnea, fatigue, 
depression, oedema, fatigue, itch. These symptoms are known to be related 
to ﬂuid overload and to end stage kidney disease. 
 
D  Medicines compliance reported on patientMpower app daily. 
  
E  Patient and healthcare professionals’ opinions of the patientMpower app 
sought by questionnaire. 
 
F  Measurement of inferior vena cava (IVC) diameter is optional. A separate 
informed consent will be sought for permission to measure IVC. Patients can 
choose to participate in the study without measurement of IVC.  
 
 
 
Conﬁdential 
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List of Figures 
 
Figure 3.1: 1: Diagram of trial design 
 
 
 
 
 
 
 
 
Conﬁdential 
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Figure 6.2.1: 1: Patient recruitment process: 
 
 
 
 
 
 
Conﬁdential 
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List of Abbreviations 
 
 
BP
blood pressure 
CV
cardiovascular 
IDWG
interdialytic weight gain (i.e. ﬂuid weight gain between dialysis 
sessions) 
IP
Internet Protocol 
IVC
Inferior vena cava 
PROM
Patient reported outcome measure 
SSH
Secure Shell 
SSL
Secure Sockets Layer 
TLS
Transport Layer Security 
 
 
 
 
Conﬁdential 
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1. 
Introduction 
1.1 
Medical background 
 
End stage kidney disease is deﬁned by kidney failure severe enough to 
require some form of renal replacement therapy. This replacement has three 
forms, kidney transplant, haemodialysis and peritoneal dialysis. 
Haemodialysis is the most common form of replacement therapy and usually 
entails three sessions of dialysis per week on alternate days starting either on 
Monday or Tuesday. The period between dialysis sessions is known as the 
inter-dialytic period and as dialysis is delivered on alternate days there is one 
inter-dialytic period per week that is longer than the other. In order to 
maintain extracellular ﬂuid balance and to prevent high blood pressure, 
haemodialysis sessions focus on removing the ﬂuid that was gained between 
dialysis sessions. 
 
Haemodialysis patients experience high rates of mortality, driven largely by 
an exceptionally high rate of cardiovascular (CV)-related mortality, which 
exceeds that of the general population by 10-to 20-fold. 1, 2  High levels of both 
inter-dialytic weight gain and rate of ﬂuid removal during dialysis have been 
linked with increased mortality, particularly during the longer interdialytic 
period 1 . It is postulated that the haemodynamic eﬀects of high ﬂuid removal 
rates during dialysis may result in cardiovascular morbidity and mortality. An 
analysis by Flythe et al reported that the risk of all-cause and cardiovascular 
mortality was increased in patients with dialysis ultraﬁltration rates over 10 
mL/h/kg. 3  In patients with co-existing congestive heart failure, the risk of 
all-cause and cardiovascular mortality was increased at ultraﬁltration rates 
between 10 and 13 mL/h/kg. 4 
 
Dialysis patients need to carefully monitor ﬂuid intake between dialysis 
sessions to avoid the requirement for unplanned dialysis sessions and/or 
high rates of ultraﬁltration. 
 
Digital medicine platforms which directly record patient experiences (e.g. 
symptoms, impact on daily life, medication compliance) and measurements 
(e.g. BP, body weight, temperature, blood sugar levels) have been developed 
for chronic medical conditions and may be valuable in helping the patients to 
manage their condition. This approach may be of value in helping 
haemodialysis patients monitor and manage their ﬂuid intake, medicines 
compliance and other relevant parameters between haemodialysis sessions. 
To date this approach has been unexplored in dialysis patients. 
 
1.2 
Product proﬁle 
 
The patientMpower application is an electronic health journal, which has 
been developed for and is used in providing support to patients with breast 
Conﬁdential 
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cancer, prostate cancer, idiopathic pulmonary ﬁbrosis and post-kidney 
transplant. The patientMpower application is downloaded as an “app” to a 
mobile phone or tablet device and patients record various parameters (e.g. 
BP, weight, temperature, symptoms, medication compliance, impact of their 
medical condition on daily life) on a daily basis. The patient has a permanent 
health diary of their self-reported measurements available to them on their 
mobile device. The app includes a health journal, which allows patients to 
record symptoms at the time they occur. This is helpful for the patient in 
monitoring their health and in preparing them for appointments with their 
healthcare professionals, particularly if there is a long interval between clinic 
visits. If appropriate, certain clinic-derived measurements (e.g. therapeutic 
drug levels) can be shared with the patient via the app.  
 
A version of the patientMpower app has been developed for kidney 
transplant recipients and this is now oﬀered as standard care at the national 
renal transplantation centre in Ireland. Patients have positively received it and 
studies of its use are ongoing. However, it is important to recognise that 
patient demographic factors vary by medical condition and this can have an 
impact on the utility and acceptability of digital health platforms in the patient 
user group. 
 
This version of the patientMpower app has speciﬁcally been developed to 
capture parameters, which are relevant for patients who are undergoing 
regular haemodialysis. Examples of measures, which can be recorded by the 
patient, include body weight, BP, temperature, activity (steps/day) and 
medication compliance. In addition, users can report symptoms resulting 
from their underlying condition or medical treatments.  
 
This study will capture longitudinal data on home measurement (by the 
patient) of parameters and symptoms relevant to the management of their 
underlying condition. The eﬀect of self-monitoring of ﬂuid intake, BP and 
body weight by the patient (using the patientMpower app and a supplied 
digital weighing scales and BP monitor) on the extent of ﬂuid removal 
required per dialysis will be assessed and compared with that of the sham 
application intervention period (no weight or BP monitoring equipment) and 
also to usual care during the run-in period of observation.  
2.
Rationale, objectives and beneﬁt-risk 
assessment 
2.1 
Rationale for performing the trial 
 
This trial will evaluate if using an electronic health journal (the patientMpower 
app) to monitor ﬂuid intake, weight gain, medicines compliance and other 
relevant parameters (e.g. BP) will help haemodialysis patients in their 
self-management and avoid the requirement for additional unplanned dialysis 
sessions, high ﬂuid removal (ultraﬁltration) rates or other adverse outcomes. 
Conﬁdential 
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The patientMpower app provides a tool to collect and share this type of 
information between patients and their healthcare professionals. 
 
This is a pilot scale study to assess if this approach has merit and could be 
tested and developed further. 
 
As no speciﬁc digital patient support platform for haemodialysis patients is 
available and validated, there is suﬃcient justiﬁcation in testing the 
eﬀectiveness and acceptability of the patientMpower app in a controlled 
observational setting. 
 
2.2 
Trial objectives 
 
The objective of this pilot-scale study is to assess the eﬀect of 
self-monitoring using the patientMpower electronic health journal [+digital 
weighing scales & blood pressure (BP) monitor] on outcomes in ambulatory 
haemodialysis patients. 
 
The primary objective will be to determine the frequency of use of the 
patientMpower app (+digital weighing scales & BP monitor) in the patients 
randomized to that observation method. This will be compared to the period 
of operation of the sham application period and to the baseline standard care 
run-in period. 
 
Additional objectives are to determine the eﬀect of patientMpower app 
(+digital weighing scales & BP monitor) on 
●
total ﬂuid removed by dialysis during the patientMpower observation 
period 
●
proportion of haemodialysis sessions in which ultraﬁltration rate is ≤ 10 
mL/kg/h.) 
●
proportion of haemodialysis sessions in which IDWG is ≤ 4%. 
●
pre-dialysis weight. 
●
pre-dialysis BP 
●
medication adherence. 
●
compliance with daily recording of ﬂuid intake, weight, BP. 
●
requirement for additional unscheduled dialysis. 
 
Patient-reported symptoms will be recorded. 
 
Patients will be randomized to either of two groups followed by the other 
observation after the cross-over: 
 
usual care run-in period (2 weeks) followed by patientMpower app (digital 
weighing scales & BP monitor) (4 weeks) followed by sham application (no 
monitoring equipment) (4 weeks) 
 
OR 
 
Conﬁdential 
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usual care run-in period (2 weeks) followed by sham application (no 
monitoring equipment) (4 weeks) followed by patientMpower app (digital 
weighing scales & BP monitor) (4 weeks) 
 
An additional objective of this observational study is to assess the 
acceptability and utility of the patientMpower app in helping haemodialysis 
patients and their healthcare professional caregivers manage their condition. 
These will be assessed from both the patient and healthcare professional 
perspective. 
 
An additional exploratory objective will be to determine the eﬀect of 
patientMpower app (+digital weighing scales & BP monitor) on inferior vena 
cava (IVC) diameter. This will be an optional measurement. Patients can 
choose to participate in the study without measurement of IVC diameter. 
 
2.3 
Beneﬁt-risk assessment 
 
The patientMpower app has been evaluated in other clinical settings (e.g. 
prostate cancer, post kidney transplant and idiopathic pulmonary ﬁbrosis). 
The kidney transplant version of the patientMpower app is now oﬀered as 
standard care at the national renal transplantation centre at Beaumont 
Hospital in Dublin, Ireland. Patients and healthcare professionals have 
positively received it and studies of its use are ongoing. 
 
It is not expected that the study or patientMpower app will create any 
additional risks for haemodialysis patients. In the event of any technical 
problems with the devices (i.e. app, digital weighing scales or BP monitor), 
patientMpower Ltd will be available to provide technical support. In addition, 
the on-call nephrology registrar at Beaumont hospital will be available to 
handle any medical enquiries with regard to BP recordings out of working 
hours and at weekends. 
 
It is not expected that measurement of IVC diameter will create any additional 
risks for haemodialysis patients. 
3. 
Description of design and trial population 
3.1 
Overall design and plan 
 
Open-label run-in usual care observation period (run-in period; 2 weeks) 
followed by randomization to two period crossover observation periods. (2 X 
4 weeks). 
 
The study will not make any other changes to the therapeutic interventions 
oﬀered to the patients. 
 
A diagram of the trial design is shown on Figure 3.1: 1 below. 
Conﬁdential 
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Figure 3.1: 1 Diagram of trial design 
 
 
3.1.1  Administrative structure of trial 
 
This is a single centre study at three haemodialysis facilities under the 
governance of Beaumont Hospital, a tertiary care centre for nephrology in 
Dublin, Ireland. 
 
The patientMpower app was developed and is owned by patientMpower, 
Dublin 8, Ireland.  
 
The protocol was designed by Dr. Conall O’Seaghdha (Principal Investigator), 
Beaumont Hospital, Dublin 9, Ireland, Dr Donal Sexton (co-investigator) and 
patientMpower Ltd., Dublin 8, Ireland. 
 
The study is sponsored by an unrestricted research grant from the Quality 
Innovation Corridor Digital Programme of eHealth Ireland. 
3.2 
Discussion of trial design, including choice of control group 
 
This is a pilot-scale, prospective, open-label, randomized, two-period, 
cross-over intervention study. 
 
Each patient will be randomized to one of the two possible observation 
sequences: 
 
Sequence 1: run-in (2 weeks): usual care followed by period 1 (4 weeks): 
patientMpower app (+digital weighing scales & BP monitor) followed by 
period 2 (4 weeks): sham application 
Conﬁdential 
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OR 
 
Sequence 2: run-in (2 weeks): followed by period 1 (4 weeks) sham 
application followed by period 2 (4 weeks): patientMpower app (+digital 
weighing scales & BP monitor) 
 
Patients will follow their usual care and haemodialysis programme throughout 
the study.  
 
The clinic observations at haemodialysis sessions during the run-in period 
will provide the baseline data for each patient. 
 
The crossover design will enable comparison of use of the patientMpower 
app + usual care with a sham application + usual care alone over a four-week 
period. Each patient will serve as their own control. 
 
The trial design will also allow assessment of the eﬀect of the patientMpower 
app on study parameters compared with usual care alone. 
 
Patients enrolled in the study will capture information on relevant parameters 
on a regular basis (daily for some parameters) using the patientMpower app. 
Patients will measure body weight at home using the supplied weighing 
scales and BP using the supplied BP monitor. The patient-measured weight, 
BP and other patient-reported data will be captured automatically by the 
patientMpower app. 
 
Clinical assessments (e.g. IDWG, BP, ultraﬁltration rate) in the same cohort of 
patients will be assessed at each dialysis visit including at  the beginning, 
after two weeks (start of Period 1), after six weeks (start of Period 2)  and at 
the end of the study.  
 
This design allows comparison of patient-reported data and their longitudinal 
trends with clinic-reported data in a cohort of patients undergoing 
haemodialysis.  
 
This design will also allow evaluation of the utility and acceptability of the 
patientMpower in a haemodialysis patient population. This will be assessed 
from both the patient and healthcare professional perspectives. 
 
3.3 
Selection of trial population 
 
3.3.1  Main diagnosis for study entry 
 
Require maintenance haemodialysis in an ambulatory care setting. 
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3.3.2  Inclusion criteria 
 
Aged at least 18 years 
 
Has daily unrestricted access to a suitable smartphone or tablet device at 
home.  
 
Has an e-mail address. 
 
Has home broadband and/or mobile data as part of their mobile phone 
service. 
 
Demonstrates understanding of correct use of the patientMpower app, digital 
weighing scales, BP monitor and other study equipment.  
Capable and willing to perform measurements (e.g. weight, BP) at home and 
record information on the patientMpower app on a daily basis.  
 
Willing to give written informed consent. 
3.3.3  Exclusion criteria 
 
Signiﬁcant confusion or any concomitant medical condition, which would 
limit the ability of the patient to record symptoms or other parameters on an 
electronic health journal. 
 
3.3.4  Removal of patients from therapy or assessments 
 
3.3.4.1 
Removal of individual patients 
 
Patients are free to withdraw from the study at any time without any impact 
on their ongoing medical care. 
 
The investigator may withdraw a patient from the study at any time if they 
believe that further participation in the study is not in the best interests of the 
patients. 
3.3.4.2 
Discontinuation of the trial 
 
The study may be terminated early if recruitment is signiﬁcantly behind 
schedule or if for any other reason, it is unlikely that the study can be 
completed. 
4. 
Study observational intervention 
 
All patients will continue to receive all usual care throughout the study as 
prescribed by their healthcare professionals. 
Conﬁdential 
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4.1 
Observational intervention to be assessed 
 
4.1.1  Identity of observational intervention and comparator(s) 
 
The study observational intervention is an electronic health journal, the 
patientMpower app (with a supplied digital weighing scales and BP monitor). 
This has been developed speciﬁcally for patients undergoing hemodialysis. 
The app is an electronic application downloaded to the patient’s mobile 
phone or tablet device. The app is designed to allow the patient to report 
various parameters relevant to haemodialysis and record these on a regular 
basis, ideally daily. The information recorded by the patients will be stored in 
a secure cloud system and will be available to the patient through their phone 
or mobile device at all times. No personal health data are stored on the 
phone or mobile device itself. 
 
Patients will be asked to report measurements on the patientMpower app 
each day. Patient-reported measures (at a minimum) will include body weight 
(one reading once/day), BP and compliance with relevant medication. 
 
Additional patient-reported measures which can be reported on the 
patientMpower app include temperature, activity levels and symptoms. These 
are optional measurements and will only be recorded where practical for the 
patients. 
 
The control observation will be usual care with a sham electronic application 
(which will not allow recording of body weight, BP or other measurements. 
4.1.2  Method of assigning patients to observational groups 
 
Patients who give informed consent and enter the study will be randomized 
to either: 
 
●
run-in period (usual care; 2 weeks) followed by patientMpower (+ 
digital weighing scales & BP monitor) + usual care; (4 weeks), followed 
by sham application + usual care; (4 weeks). 
 
or 
 
●
run-in period (usual care; 2 weeks) followed by sham application + 
usual care; (4 weeks), followed by patientMpower (+ digital weighing 
scales & BP monitor) + usual care; (4 weeks). 
 
 
A random sequence, random block number randomization schedule will be 
used to assign patients to either observation Sequence 1 or observation 
Sequence 2. (Observation sequences are described above in section 3.2.) 
The randomization schedule with will be provided by a centralised electronic 
Conﬁdential 
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randomization service (Sealed Envelope, Clerkenwell Workshops, London 
EC1R 0AT, UK).  
 
As the study will be conducted in three hemodialysis centers under the 
governance of Beaumont Hospital a separate randomization schedule will be 
generated for each centre. 
 
4.1.3  Blinding and procedures for unblinding 
4.1.3.1 
Blinding 
 
The study is open-label. 
 
4.2 
Concomitant therapy, restrictions and rescue treatment 
4.2.1  Rescue medication, emergency procedures and additional 
treatment 
 
If any patient or their healthcare professional has a concern with regard to BP 
or weight measurements the renal registrar on call at Beaumont Hospital will 
respond to calls out of hours and at weekends.  
 
4.2.1.1 
Management of acute exacerbations 
 
Any exacerbations of the patient’s underlying medical condition(s) should be 
treated according to standard procedures. 
 
4.2.1.2 
Management of other adverse events 
 
Any other adverse events should be treated according to standard 
procedures. 
4.2.2  Restrictions 
4.2.2.1 
Restrictions on concomitant treatment 
 
There are no restrictions on concomitant treatment. All concomitant 
treatments as prescribed by the patients’ healthcare professionals are 
allowed. Patients will continue to take all medicines and other treatments as 
prescribed by their healthcare professionals. As per the co-interventions 
protocol (Appendix 10.1), all nephrologists working at Beaumont Hospital will 
be asked not to alter their usual ﬂuid balance management during the study. 
4.2.2.2
Restrictions on diet and life-style 
 
Conﬁdential 
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The study does not mandate any additional restrictions on diet or life-style. 
Patients will continue to follow all instructions on diet, exercise and lifestyle 
as directed by their healthcare professionals. 
4.3 
Treatment compliance 
 
Patients will use the patientMpower app to record daily compliance with 
medications prescribed for management of their haemodialysis and 
associated medical conditions. 
 
5 
Variables and their assessment 
 
5.1 
Eﬃcacy 
 
The objective of this pilot-scale cross-over open label randomized study is to 
assess the eﬀect of self-monitoring using the patientMpower electronic 
health journal [+digital weighing scales & BP monitor] on outcomes in 
ambulatory haemodialysis patients (see section 5.1.1.2 below). 
 
The primary objective will be to determine the eﬀect of the patientMpower 
app (+digital weighing scales & BP monitor) on total ﬂuid removed by dialysis 
during the patientMpower observation period (compared with the sham 
period). 
 
The frequency of use of the patientMpower app (+digital weighing scales & 
BP monitor) and patient-reported symptoms will be recorded. 
 
The acceptability and utility of the patientMpower app in helping 
haemodialysis patients and their healthcare professional caregivers manage 
their condition will be assessed (from both the patient and healthcare 
professional perspective). 
 
5.1.1  Eﬃcacy endpoints 
 
5.1.1.1 
Primary endpoint 
 
The primary endpoint will be the level of engagement of patients with the 
patientMpower app.  
 
 
The primary endpoint variables are: 
 
●
number of patients asked to take part in the study 
●
number patients who give informed consent to take part in the study 
Conﬁdential 
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●
number consented patients who download the app to their 
smartphone or tablet device 
●
number patients who use the app at least once after downloading 
●
number of patients who use the app more than once 
●
frequency of use by each patient 
●
date intervals between informed consent, download, ﬁrst use 
●
date intervals between ﬁrst and subsequent uses 
●
frequency of recording study parameters (weight, BP) at home 
5.1.1.2 
Secondary endpoints 
 
The secondary endpoints include determination of the eﬀect of 
patientMpower app (+digital weighing scales & BP monitor) on 
●
proportion of haemodialysis sessions in which ultraﬁltration rate is ≤ 10 
mL/kg/h. 
●
proportion of haemodialysis sessions in which IDWG is ≤ 4%. 
●
total ﬂuid removed by dialysis during the patientMpower observation 
period 
●
pre-dialysis weight. 
●
pre-dialysis BP 
●
medication adherence. 
●
compliance with daily recording of ﬂuid intake, weight, BP. 
●
requirement for additional unscheduled dialysis. 
 
The secondary endpoint variables include 
●
body weight (measured at home and pre-dialysis at each dialysis 
session) 
●
BP (measured at home and pre-dialysis at each dialysis session) 
●
number of additional unscheduled dialysis sessions 
●
number and frequency of records of compliance parameters 
●
compliance with prescribed medicines 
 
The most recent oﬀ-dialysis weight will be used as the reference weight 
target rather than the dry weight. The “most recent oﬀ-dialysis weight” will be 
deﬁned as the mean post-dialysis weight over the previous three (3) 
haemodialysis sessions before the start of the patientMpower observation 
period. 
 
Symptoms (e.g. dyspnoea, fatigue, oedema, headache, thirst, 
light-headedness) will be recorded by the patients. 
 
 
The patient’s opinion of the utility and acceptability of the patientMpower app 
as assessed by their response to questions (binary and Likert scale):  
 
●
using the patientMpower app helped me to take the correct dose of 
my medicines every day (strongly agree/agree/disagree/strongly 
disagree) 
Conﬁdential 
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●
using the patientMpower app gave me more conﬁdence/a greater 
sense of control in managing my health (strongly 
agree/agree/disagree/strongly disagree) 
●
my preference for using the patientMpower app versus not using it 
(yes, no preference, no) 
●
my diﬃculty rating in using the patientMpower app (very easy, easy, 
diﬃcult, very diﬃcult) 
●
what was the eﬀect of using the patientMpower app on my well-being 
and daily life (positive, negative, optional open text ﬁeld for patient to 
give opinion) 
●
do I want to continue using the patientMpower app after the end of the 
study (yes, no) 
 
This will also be assessed by the healthcare professional’s response to the 
following questions: 
 
●
preference for using the patientMpower app versus not using it (yes, 
no preference, no) 
●
diﬃculty rating in using the patientMpower app (very easy, easy, 
diﬃcult, very diﬃcult) 
●
did using the patientMpower app help me to help the patient manage 
their health better? (yes, no) 
●
did using the patientMpower app help the patient to take their 
medicines at the correct dose every day (yes, no) 
●
do I believe the patient should continue using the patientMpower app 
after the end of the study (yes, no) 
●
what other measurements, reminders or information would be useful to 
have on the patientMpower app? (Open text for healthcare 
professional to give opinion) 
 
An additional exploratory secondary endpoint will be to determine the eﬀect 
of patientMpower app (+digital weighing scales & BP monitor) on inferior 
vena cava (IVC) diameter (measured immediately pre-dialysis) . This will be an 
optional measurement. Patients can choose to participate in the study 
without measurement of IVC diameter. The variables for this endpoint are 
longitudinal and transverse IVC diameter.  
 
 
5.1.2  Assessment of eﬃcacy 
 
The primary eﬃcacy endpoint data will be assessed by (a) comparison of the 
endpoint variables observed in the patientMpower (+digital weighing scales & 
BP monitor) + usual care period with the sham application + usual care 
period and (b) comparison of the endpoint data in both randomized 
observation periods with the run-in period data.  
 
The secondary eﬃcacy endpoint data will be assessed by (a) comparison of 
the endpoint variables observed in the patientMpower (+digital weighing 
Conﬁdential 
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scales & BP monitor) + usual care period with the sham application + usual 
care period and (b) comparison of the endpoint data in both randomized 
observation periods with the run-in period data.  
 
The acceptability and utility of the patientMpower app will be assessed by 
analysis of the responses to the patient and healthcare professional 
questionnaires (described above in 5.1.1.2). 
 
Data on the level of engagement and the patient and healthcare professional 
opinions on utility and acceptability will be described and tabulated.  
5.2 
Safety 
 
It is not anticipated that any safety issues will arise from use of the 
patientMpower app. Issues regarding abnormal blood pressure readings will 
be addressed by the nephrology department at Beaumont Hospital. 
 
Any adverse events observed with medical treatments should be reported to 
the manufacturers or suppliers of those treatments. 
 
5.3. 
Other variables 
 
Demographic data (date of birth, gender, medication prescribed). 
 
Type of smartphone or tablet device (i.e. iPad or Android tablet, iPhone or 
Android phone). 
 
5.4 
Appropriateness of measurements 
 
The secondary eﬃcacy endpoint parameters are measurements which are 
important measures of ﬂuid intake and renal function in haemodialysis 
patients. 
 
The questionnaires used to assess usefulness and patient acceptability have 
been used to assess these parameters for other patient support platforms.  
6
Investigational plan 
 
Patients who participate in the study will follow their usual care and 
haemodialysis programme. They will then be randomized a sequence of 
either the patientMpower app (+ digital scales & BP monitor) + usual care 
followed by the sham application or vice versa. They will be encouraged to 
use the patientMpower app, digital weighing scales and BP monitor every 
day during that observation period to record parameters relevant to their 
health status (described in section 5.1.1.2 above). 
 
Conﬁdential 
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6.1 
Visit schedule 
 
The total observation period will be approximately ten (10) weeks. During this 
time patients can be expected to attend for a haemodialysis session three 
times a week on average. 
 
6.2 
Details of trial procedures at selected visits 
 
6.2.1  Patient recruitment process 
 
The patient recruitment process is summarized in the ﬂow-chart on page 6 
and in Figure 6.2.1: 1 below. 
 
Approximately 300 patients attend for dialysis under the governance of 
Beaumont Hospital. All eligible individuals will be invited to participate. It is 
estimated that a total of 50 people will be enrolled in this study. 
 
 
Conﬁdential 
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Figure 6.2.1: 1 Patient recruitment process: 
 
 
 
 
 
 
The study centre will publicise the study to their potential patient population.  
 
When potential patients who are interested in the study attend for a usual 
care haemodialysis visit, the research staﬀ will discuss the study 
(face-to-face) with the patient. This discussion will include assessing if the 
patient has a suitable phone/tablet device, internet access and e-mail 
address.  
 
If the person wishes to participate, they will give informed consent 
electronically. The patient will receive a paper and electronic copy of the 
patient information document. 
 
This is the start of the usual care run-in period.  
 
The randomized allocation of the observation group will be done at or after 
this visit but use of the patientMpower app or sham application will not start 
until approximately 2 weeks later.  
 
The research team at the study centre will advise patientMpower of email 
address of people who have given their electronic consent to participate and 
of the date of the start of run-in. 
 
Conﬁdential 
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The independent randomization service will advise patientMpower of the 
observation sequence allocated by randomization (see Section 3.2 for 
description). 
 
patientMpower Ltd. will provide information pack (electronic; includes 
instructions on installation of patientMpower app or sham application, digital 
weighing scales and BP monitor (if randomized to that sequence) to the 
patient at the planned date of 2-week usual care haemodialysis visit to study 
centre. 
 
If required, patientMpower Ltd will contact or meet the patient to oﬀer help 
with installation of patientMpower app or sham application and pairing of 
devices (so that all are installed and operating prior at the planned 2-week 
usual care haemodialysis clinic visit). 
 
6.2.2
Assessments during observation period 
 
The trial procedures at each visit are summarized in the ﬂow chart on page 8. 
 
6.2.2.1 
Baseline visit 
 
At a planned usual care haemodialysis visit to study centre, the study centre 
research team will discuss the study with the patient and conﬁrm their 
patients understanding of the study processes and their willingness to 
participate. A paper version of the full-length patient information document 
will be given to the patient. The patient will have the opportunity to ask 
questions on the study processes. 
 
Demographic data, vital signs, medical history and concomitant therapy for 
renal and other relevant conditions will be recorded. 
 
The following parameters will be assessed and recorded in the clinic records: 
●
actual weight before haemodialysis 
●
target weight 
●
actual systolic and diastolic BP before haemodialysis 
●
ultraﬁltration rate at baseline haemodialysis session 
 
The patient will be randomly allocated to one of two possible observation 
sequences: 
 
EITHER 
 
Sequence 1: run-in (2 weeks): usual care followed by period 1 (4 weeks): 
patientMpower app (+digital weighing scales & BP monitor) followed by 
period 2 (4 weeks): sham application 
 
OR 
Conﬁdential 
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Sequence 2: run-in (2 weeks): followed by period 1 (4 weeks) sham 
application followed by period 2 (4 weeks): patientMpower app (+digital 
weighing scales & BP monitor) 
 
Randomisation will be allocated by contacting a centralized randomization 
service (Sealed Envelope Ltd., London, UK). 
 
The centralised randomization service will automatically advise 
patientMpower of the observation sequence allocated to the patient. 
 
The patient will attend for haemodialysis as required for a run-in period of 
approximately 2 weeks. There will be no change to their usual care during 
this run-in period.  
 
At each haemodialysis visit during run-in the following parameters will be 
assessed and recorded: 
●
actual weight before haemodialysis 
●
target weight 
●
actual systolic and diastolic BP before haemodialysis 
●
ultraﬁltration rate at baseline haemodialysis session 
●
any requirement for additional unplanned haemodialysis sessions 
 
6.2.2.2 
Week 2 clinic visit (start of randomized observation period 
1) 
 
The trial procedures after the Week 2 visit will vary dependent on the 
observation sequence allocated to the patient. 
 
patientMpower Ltd will contact or meet the patient and help install the 
patientMpower app or sham application to the patient’s mobile phone or 
tablet prior to this visit. 
 
The patient should bring their mobile phone or tablet device with them to the 
clinic.  
 
If allocated to observation sequence 1 
The patientMpower app will be downloaded to the patient’s mobile phone or 
tablet device prior to or at this visit.  (A tablet device will be supplied to the 
patients if they do not have access to a suitable smart device at home.) The 
patient will also be supplied with a digital weighing scales and BP monitor.  
 
The patients will be instructed in the correct use of the digital weighing scales 
and BP monitor and uploading of data to the patientMpower app. The 
patients’ understanding of the patientMpower app, digital weighing scales, 
BP monitor and the study procedures should be checked before they leave 
the clinic. 
 
Conﬁdential 
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During observation period 1 patients will attend for haemodialysis sessions 
as usual and will be encouraged to record self-observed parameters on the 
patientMpower app on a regular basis for about 4 weeks. The following 
should be recorded by the patient on the patientMpower app each day: 
●
body weight 
●
BP 
●
compliance with medication 
●
ﬂuid intake 
●
symptoms 
 
Patients will receive reminders (via the patientMpower app) at appropriate 
intervals to record study parameters. Other parameters (e.g. steps/day) can 
be recorded by the patient (if suitable measurement devices are available to 
the patient. 
 
If allocated to observation sequence 2 
 
The sham platform will be downloaded to the patient’s mobile phone or tablet 
device at or prior to this visit.  (A tablet device will be supplied to the patients 
if they do not have access to a suitable smart device at home.) 
 
During observation period 1, patients allocated to the sham platform, patients 
will attend for haemodialysis sessions and follow all usual care advice for the 
next 4 weeks.  
 
At each haemodialyis session the following parameters will be assessed and 
recorded in the clinic records: 
●
actual weight before haemodialysis 
●
target weight 
●
actual systolic and diastolic BP before haemodialysis 
●
ultraﬁltration rate at each haemodialysis session 
 
If the patient has given consent to measurement of IVC diameter, this will be 
assessed by ultrasound at this visit. The procedure is described below: 
 
●
Lie the patient down at roughly 45 degrees. If images are poor, will 
attempt other positions such as lying ﬂat and maneuvers to relax 
abdominal muscles.  
●
Switch on and prepare the settings for the handheld ultrasound 
machine or echo machine.  
●
Use the cardiac preset function. 
●
Apply ultrasound gel to the ultrasound probe and to the patient’s 
chest. 
●
Obtain a subcostal view and locate the right atrium. 
●
Rotate the probe to visualize the IVC. 
●
Measure both the longitudinal and transverse diameter of the IVC 2 cm 
below the right atrium and record the anonymised measurements 
securely on an encrypted drive. 
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The diameter lengths are calculated by calibrating against the scale on 
the right side of the screen.  
●
Once measurements are taken, let the patient know the procedure is 
ﬁnished and help them to clean the gel. 
●
Clean the ultrasound probe, apply disinfectant provided and then 
return the ultrasound machine to its charging bay.  
 
6.2.2.3
Week 6 visit (crossover visit; end period 1; start period 2) 
 
At approximately 4 weeks after starting period 1, patients will return to the 
clinic for a routine haemodialysis session. At this visit, the following 
parameters will be assessed and recorded in the clinic records: 
●
actual weight before haemodialysis 
●
target weight 
●
actual systolic and diastolic BP before haemodialysis 
●
ultraﬁltration rate at each haemodialysis session 
 
If allocated to observation sequence 1 
 
The patient will be asked to stop using the patientMpower app for the next 
four weeks. (The data feed from the digital weighing scales and BP monitor 
to the patientMpower app will be deactivated by patientMpower Ltd.). The 
sham application will be activated by patientMpower Ltd. 
 
The patient and healthcare professional opinion on the usefulness and 
acceptability of the patientMpower app will be assessed and recorded. (The 
questions are described in section 5.1.1.2 above.) 
 
During observation period 2, patients allocated to the sham platform will 
attend for haemodialysis sessions and follow all usual care advice for the 
next 4 weeks.  
 
At each haemodialyis session the following parameters will be assessed and 
recorded in the clinic records: 
●
actual weight before haemodialysis 
●
target weight 
●
actual systolic and diastolic BP before haemodialysis 
●
ultraﬁltration rate at each haemodialysis session 
 
If allocated to observation sequence 2 
 
The patientMpower app will have been downloaded to the patient’s mobile 
phone or tablet device at or prior to this visit. The patient will also be supplied 
with a digital weighing scales and BP monitor.  
 
The patient will be instructed in the correct use of the digital weighing scales 
and BP monitor and uploading of data to the patientMpower app. The 
patient’s understanding of the patientMpower app, digital weighing scales, 
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BP monitor and the study procedures should be checked before they leave 
the clinic. 
 
During observation period 2, patients will attend for haemodialysis sessions 
as usual and will be encouraged to record self-observed parameters on the 
patientMpower app on a regular basis for about 4 weeks. The following 
should be recorded by the patient on the patientMpower app each day: 
●
body weight 
●
BP 
●
compliance with medication 
●
ﬂuid intake 
●
symptoms 
 
Patients will receive reminders (via the patientMpower app) at appropriate 
intervals to record study parameters. Other parameters (e.g. steps/day) can 
be recorded by the patient (if suitable measurement devices are available to 
the patient. 
 
If the patient has given consent to measurement of IVC diameter, this will be 
assessed by ultrasound at this visit. The procedure is as described above. 
 
6.2.2.4 
Week 10 visit (end period 2; end of study)  
 
At approximately 4 weeks after starting observation period 2, patients will 
return to the clinic for a routine haemodialysis session.  
 
At this visit, the following parameters will be assessed and recorded in the 
clinic records: 
●
actual weight before haemodialysis 
●
target weight 
●
actual systolic and diastolic BP before haemodialysis 
●
ultraﬁltration rate at each haemodialysis session 
 
The patient and healthcare professional opinion on the usefulness and 
acceptability of the patientMpower app will be assessed and recorded. (The 
questions are described in section 5.1.1.2 above.) 
 
Any relevant clinic outcomes (e.g. additional unscheduled dialysis sessions) 
will be documented. 
 
If the patient has given consent to measurement of IVC diameter, this will be 
assessed by ultrasound at this visit. The procedure is as described above. 
 
This visit is the end of the study.  
 
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7. 
Statistical methods and determination of sample 
size 
 
This a pilot-scale study to assess the feasibility of haemodialysis patients 
using the patientMpower app to monitor their weight, blood pressure and 
other relevant parameters to monitor their health. 
 
7.1 
Statistical design and model 
 
Prospective, open-label run-in period followed by open randomization to 
two-period cross over group comparison of patientMpower app (+digital 
weighing scales & BP monitor) versus sham electronic app (no scales or BP 
monitor). No washout between observation periods. 
 
Usual care for all patients throughout study. 
7.2 
Null and alternative hypotheses 
 
Not relevant. 
 
7.3 
Planned analyses 
 
Results will be collected and summarized for descriptive statistical display. 
 
The eﬃcacy data of the two observation groups in the randomized 
observation periods will be compared with each other and separately with the 
eﬃcacy data of the run-in period using mixed eﬀects models and generalized 
estimating equations.  
 
 
 
Conﬁdential 
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7.3.1  Primary analyses 
 
The frequency of use and engagement by patients with the patientMpower 
app will be tabulated and described. 
 
7.3.2  Secondary analyses 
 
Trends in ultraﬁltration rate, pre-dialysis weight and BP at each haemodialysis 
session will be compared between the two randomized observation periods. 
 
The number of haemodialysis sessions in which the IDWG is ≤4% will be 
tabulated and compared between the randomized intervention periods and 
baseline periods. 
 
The total volume of ﬂuid removal in all hemodialysis sessions will be 
compared between the two randomized observation periods. 
 
Medication adherence will be compared between observation periods. 
 
Data from both randomized observation periods will be compared with the 
data observed during the run-in period for the same patients. 
 
The observed IVC diameters will be compared between the two randomized 
observation periods. 
 
Compliance with daily recording of ﬂuid intake, weight, and blood pressure 
will be tabulated and displayed 
 
Patient-reported symptoms will be tabulated and displayed. 
 
The acceptability and utility of the patientMpower app will be assessed by 
analysis of the responses to the patient and healthcare professional 
questionnaires (described above in 5.1.1.2). 
 
A possible limitation of the analysis is that there may be a treatment order 
eﬀect (i.e. carry over eﬀect of behaviours), particularly when moving from the 
patientMpower (+digital weighing scales & BP monitor) observation period to 
the sham application period. 
 
7.3.3  Safety analyses 
 
Not relevant 
 
7.3.4  Interim analyses 
 
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None planned. 
7.3.5  Health economic analyses 
 
The number of additional unscheduled haemodialysis sessions will be 
recorded and decided upon by the outcome adjudication committee (see 
Appendix 10.4). 
 
7.4 
Handling of missing data 
 
No imputations of missing data will be made. 
 
7.5. 
Randomisation 
 
At the baseline visit, patients will be randomly allocated to either of two 
observation periods followed by the other in a cross-over design: 
usual care run-in period (2 weeks) followed by patientMpower app (+digital 
weighing scales & BP monitor) + usual care (4 weeks) followed by sham 
application + usual care (4 weeks) 
 
or  
 
usual care run-in period (2 weeks) followed by sham application + usual care 
(4 weeks), followed by patientMpower app (+digital weighing scales & BP 
monitor) + usual care (4 weeks) 
 
The randomization will be open. 
 
7.6 
Determination of sample size 
 
This is a pilot scale study. The sample size is chosen arbitrarily by an 
estimation of the likely number out of a total of 300 dialysis patients who 
might enroll in the study. 
 
8. 
Informed consent, data protection and trial 
records 
 
8.1 
Study approval, patient information and informed consent 
 
The study will be approved by the relevant ethics committee(s) for the 
participating centre. 
 
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The study will be discussed with each patient and they will be provided with 
a written document describing the study conditions and procedures. 
 
All patients will give written informed consent before enrollment 
 
8.2 
Data quality assurance 
 
All endpoint data will be stored on a central database for analysis. The data 
as reported by the patients will not be queried before descriptive statistical 
analysis tables are prepared 
 
8.3 
Records 
 
8.3.1  Source documents 
 
The original electronic data will be the source document. 
 
8.3.2  Direct access to source data and documents 
 
Source data veriﬁcation will not be performed. 
 
8.3.3  Storage of records  
 
Medical data relating to patient care will be stored in the medical records 
according to the usual procedures of the treatment site(s).  
 
The endpoint data collected by the patients and recorded on the 
patientMpower app will be stored in a secure cloud database (located in the 
European Economic Area) managed by patientMpower Ltd. These data will 
be available to patients indeﬁnitely to aid them in self-management of their 
medical condition. Patients can request deletion of their data from the 
patientMpower cloud database at any time. 
 
8.4 
Statement of conﬁdentiality 
 
Patients will only be identiﬁed by a unique identiﬁcation number on the trial 
database and data will be anonymised. All data will be treated as 
conﬁdential.  
Each patient’s data is linked to their unique identiﬁcation number.  
 
The patientMpower application and storage are designed with stringent 
security protocols. The solution is hosted in Google Compute Engine.  The 
security protocols used include: 
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application uses a PostgreSQL database ( https://www.postgresql.org/ ) 
which is backed up nightly 
●
application is patched regularly to ensure it is maintained against 
security vulnerabilities 
●
only certain Internet Protocol (IP) addresses can login to the cloud 
infrastructure using Secure Shell (SSH) with IP whitelists and 
public/private key access only 
●
built-in ﬁrewalls 
●
encrypted data storage  
●
patientMpower staﬀ access to the PostgreSQL database, and content 
system is restricted and monitored 
●
a unique username and password for each user.  
●
audit and accounting of all access to the system is recorded. In the 
event of any staﬀ looking at data without proper authorisation, there is 
an audit trail of what data was viewed 
●
data transfer between the patient mobile device and cloud server is 
sent securely via Transport Layer Security (TLS) and the platform’s 
cloud infrastructure uses an Extended Validation Secure Sockets Layer 
(SSL) Certiﬁcate issued by Digicert (https://www.digicert.com) 
●
data on the server is encrypted, only authenticated users can access 
the server 
 
Access to data stored on the patientMpower app will be restricted to named 
individuals at patientMpower Ltd who will each have a unique userID and 
password. 
  
8.5 
Completion of trial 
 
The trial will be complete when 50 patients have completed the 10-week 
observation period. 
 
If it appears to be unlikely that the target number of patients can be achieved 
(e.g. because of slow recruitment) a lower target will be set (after discussion 
and agreement with investigator sites). 
 
8.6 
Protocol violations 
 
All data will be analysed on an intention-to-treat basis without regard to 
protocol violations. 
 
8.7 
Compensation available to the patient in the event of 
study-related injury 
 
It is not anticipated that any study-related injury will occur 
 
Conﬁdential 
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9
References 
 
 
1.
Foley RN, Gilbertson DT, Murray T , et al. Long interdialytic interval and 
mortality among patients receiving hemodialysis.  N Engl J Med 2011; 
365:  1099-1107. 
 
2.
Collins AJ, Foley RN, Herzog C , et al. Excerpts from the US Renal Data 
System 2009 Annual Data Report.  Am J Kidney Dis 2010;  55:  S1-420, 
A426-427. 
 
3.
Flythe JE, Kimmel SE, Brunelli SM. Rapid ﬂuid removal during dialysis 
is associated with cardiovascular morbidity and mortality.  Kidney Int 
2011;  79:  250-257. 
 
4.
Assimon MM, Flythe JE. Rapid ultraﬁltration rates and outcomes 
among hemodialysis patients: re-examining the evidence base.  Curr 
Opin Nephrol Hypertens 2015;  24:  525-530. 
 
10.
Appendices 
 
Appendix 10.1
Cointerventions protocol 
 
All nephrologists working at Beaumont Hospital will be asked not to alter their 
usual ﬂuid balance management during the study 
Appendix 10.2
Contamination protocol 
 
Patients will be asked not to discuss the details of the study with each other 
or with the dialysis nurses or any other staﬀ. This is to avoid those in the 
sham arm from mimicking behaviors in the intervention arm by knowing what 
it entails.  
 
Appendix 10.3
Steering committee 
 
The steering committee will consist of Dr Conall O’Seaghdha and Dr. Donal 
Sexton (Beaumont Hospital, Dublin 9, Ireland), Colin Edwards and Eamonn 
Costello (patientMpower Ltd., The Digital Depot, Thomas Street, Dublin 8, 
Ireland).  
Appendix 10.4
Adjudication committee  
 
Conﬁdential 
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The adjudication committee will consist of the Steering Committee and an 
independent nephrologist physician (not involved in the study). The purpose 
of the adjudication committee is to review and decide on key clinical 
outcomes. For example, the adjudication committee will decide whether a 
dialysis session during the study period was extra and unscheduled or not.  
Appendix 10.5
Recruitment of patients 
 
Research assistants will undertake recruitment of participants. These 
individuals will be independent and will not be physicians or nurses who are 
responsible for the daily medical care of the potential patients. This is to 
ensure that dialysis patients do not feel obliged to participate.  
Appendix 10.6
Training of personnel 
 
patientMpower Ltd have skilled personnel capable of demonstrating the use 
of the devices to study patients.  
Appendix 10.7
Trial registration on public registry 
 
After research ethics approval, the study will be registered on the 
international clinical trials registry at www.clinicaltrials.gov. 
Appendix 10.8
Funding 
 
This study is funded by the Health Service Executive Quality Innovation 
Corridor programme.  
Appendix 10.9
Incentives for participation:  
 
Patients who take part in the study will be permitted to keep the BP monitor 
and electronic scales after the study is complete. This equipment will be 
worth approximately 200 euro. They will be able to continue to use these 
(with or without use of the patientMpower app) for as long as they wish. 
 
Conﬁdential 
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