Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis

• Sponsor: patientMpower Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03403491
• Collaborator: Health Service Executive, Ireland (Other)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

Pilot-scale study to assess the effect of self-monitoring using the patientMpower electronic health journal (pMp app) [+digital weighing scales & BP monitor] on outcomes in ambulatory haemodialysis patients. Design: prospective, open-label, random order, sham-controlled, two-period crossover comparison of the pMp app [+digital weighing scales & BP monitor] compared with a sham application (without weighing scales or BP monitor). Duration: 10 weeks (usual care run-in for 2 weeks followed by 2 x 4 observation periods).

Primary objective is to determine the frequency of use of the pMp app [+digital weighing scales & BP monitor] in patients randomized to that observation method. Additional objectives are to determine the effect of pMp app [+digital weighing scales & BP monitor] on proportion of haemodialysis sessions in which ultrafiltration rate is ≤ 10 mL/kg/h and in which interdialytic weight gain (IDWG) is ≤ 4% and effect of pMp on pre-dialysis weight and BP, medication adherence, compliance with daily recording (of fluid intake, weight, BP) and requirement for additional unscheduled dialysis.

An additional objective is to assess the acceptability and utility of the pMp app in helping hemodialysis patients and their healthcare professional caregivers manage their condition (assessed from both patient and healthcare professional perspective).

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis	Other: patientMpower application; Other: sham application	N/A

Detailed Description

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 application (+digital weighing scales & BP monitor) followed by period 2 (4 weeks): sham application

OR

Sequence 2: run-in (2 weeks): followed by period 1 (4 weeks) sham application followed by period 2 (4 weeks): patientMpower application (+digital weighing scales & BP monitor)

The study will not make any other changes to the therapeutic interventions offered to the patients. Patients will follow their usual care and hemodialysis programme throughout the study.

Proposed sample size is approximately 50 patients.

Patients will be recruited through three haemodialysis facilities under the governance of Beaumont Hospital, a tertiary care centre for nephrology in Dublin, Ireland.

The study observational intervention is an electronic health journal, the patientMpower application (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 hemodialysis 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.

Patient-reported measures (at a minimum) will include body weight (at least one reading /day), BP and compliance with relevant medication. Additional patient-reported measures which can be reported on the patientMpower app include body temperature, activity levels and symptoms.

The control observation will be usual care with a sham electronic application (which will not allow recording of body weight, BP or other measurements).

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 hemodialysis patients.The primary objective will be to determine the frequency of use of the patientMpower app (+digital weighing scales & BP monitor).

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Prospective, open-label, sham-controlled, observational study. Usual care run-in period (2 weeks) followed by random order 2 x 4-week crossover periods. Comparison is active pMp app [+ digital weighing scales + BP monitor] for 4 weeks vs. sham application for 4 weeks.Prospective, open-label, sham-controlled, observational study. Usual care run-in period (2 weeks) followed by random order 2 x 4-week crossover periods. Comparison is active pMp app [+ digital weighing scales + BP monitor] for 4 weeks vs. sham application for 4 weeks.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Nov 7, 2018
• Actual Primary Completion Date: Mar 8, 2019
• Actual Study Completion Date: Mar 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Sequence 1 Usual care for 2 weeks followed by using patientMpower application [+digital weighing scales & BP monitor] for 4 weeks followed by sham application (without digital scales or BP monitor) for 4 weeks.	Other: patientMpower application; electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms; Other: sham application; dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms
Other: Sequence 2 Usual care for 2 weeks followed by sham application (without digital scales or BP monitor) for 4 weeks followed by using patientMpower application [+digital weighing scales & BP monitor] for 4 weeks.	Other: patientMpower application; electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms; Other: sham application; dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms

Outcome Measures

Primary Outcome Measures

1. Patient Engagement With patientMpower App to Record Body Weight [28 days]

   Actual number of days body weight reported by patient on patientMpower app

Secondary Outcome Measures

1. Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h) [28 days]

   Proportion of hemodialysis sessions in which ultrafiltration rate is less than/equals 10mL/kg/h

2. Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight) [28 days]

   Average interdialytic weight gain as percentage of patient's dry weight

3. Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute) [28 days]

   Average interdialytic weight gain in kg

4. Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%) [28 days]

   Proportion of hemodialysis sessions in which interdialytic weight gain is less than/equals 4%

5. Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight [28 days]

   predialysis weight

6. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure [28 days]

   pre-dialysis supine systolic blood pressure

7. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure [28 days]

   pre-dialysis supine diastolic blood pressure

8. Patient Engagement With patientMpower App to Record Medication Adherence [28 days]

   actual number of days medication adherence reported by patient on patientMpower app

9. Patient Engagement With patientMpower App to Record Blood Pressure. [28 days]

   actual number of days blood pressure reported by patient on patientMpower app

10. Patient Engagement With patientMpower App to Record Symptoms [28 days]

    Actual number of days symptoms reported by patient on patientMpower application

11. Patient Engagement With patientMpower App to Record Fluid Intake [28 days]

    Actual number of days fluid intake reported by patients on patientMpower application

12. Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis. [28 days]

    number of patients requiring additional unscheduled hemodialysis sessions

13. Patient Opinion on Utility and Acceptability of patientMpower Application [28 days]

    Questionnaire-based assessment: 7 questions. [pMp = patientMpower intervention] using pMp helped me to take correct dose of my medicines every day using pMp gave me more confidence/greater sense of control in managing my health my preference for using pMp my difficulty rating in using pMp effect of using pMp on my well-being and daily life do I want to continue using pMp after study end did I like using pMp Possible responses Q1, Q2: strongly agree/agree/disagree/strongly disagree; Q3: yes/no preference/no; Q4: very easy/easy/difficult/very difficult; Q5: positive/negative; Q6: yes/no; Q7: 10-point linear scale: 1 (did not like at all) to 10 (liked a lot)

14. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility [28 days]

    number of patients with at least 50% collapsibility

15. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter [28 days]

    longitudinal diameter

16. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter [28 days]

    transverse diameter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Requires maintenance hemodialysis in an ambulatory care setting.

• Aged at least 18 years.

• Has daily unrestricted access to a suitable smart phone 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 application, 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 application on a daily basis.

• Willing to give written informed consent.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renal Dialysis Centre, Beaumont Hospital	Dublin		Ireland

Sponsors and Collaborators

• patientMpower Ltd.
• Health Service Executive, Ireland

Investigators

• Principal Investigator: Renal Dialysis Centre, Beaumont Hospital, Dublin 9, Ireland

Study Documents (Full-Text)

• Study Protocol - Dec 20, 2018
• Statistical Analysis Plan: Description - Jun 26, 2019
• Statistical Analysis Plan: Appendix 1 - Jun 26, 2019

More Information

Publications

None provided.

• Responsible Party: patientMpower Ltd.
• ClinicalTrials.gov Identifier: NCT03403491
• Other Study ID Numbers: Hemodialysis patientMpower02
• First Posted: Jan 18, 2018
• Last Update Posted: Jun 16, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Sequence 1	Sequence 2
Arm/Group Description	Usual care for 2 weeks followed by using patientMpower application [+digital weighing scales & BP monitor] for 4 weeks followed by sham application (without digital scales or BP monitor) for 4 weeks. patientMpower application: electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms sham application: dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms	Usual care for 2 weeks followed by sham application (without digital scales or BP monitor) for 4 weeks followed by using patientMpower application [+digital weighing scales & BP monitor] for 4 weeks. patientMpower application: electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms sham application: dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms
Period Title: Overall Study
STARTED	20	23
COMPLETED	17	18
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	All Patients
Arm/Group Description	All patients who started patientMpower observation period
Overall Participants	43
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	37 86%
>=65 years	6 14%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.42 (13.98)
Sex: Female, Male (Count of Participants)
Female	15 34.9%
Male	28 65.1%
Race/Ethnicity, Customized (Count of Participants)
white	39 90.7%
black	3 7%
Asian	1 2.3%
Region of Enrollment (participants) [Number]
Ireland	43 100%
time since first-ever hemodialysis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.44 (3.71)
vascular access modality (Count of Participants)
permcath	25 58.1%
arteriovenous fistula	18 41.9%

Outcome Measures

1. Primary Outcome

Title	Patient Engagement With patientMpower App to Record Body Weight
Description	Actual number of days body weight reported by patient on patientMpower app
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who started patientMpower observation period and who recorded weight at least once

Arm/Group Title	All Patients
Arm/Group Description	All patients who started patientMpower observation period
Measure Participants	43
Mean (Standard Deviation) [days]	24 (6)

2. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h)
Description	Proportion of hemodialysis sessions in which ultrafiltration rate is less than/equals 10mL/kg/h
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Average of the proportion of hemodialysis sessions per patient in which ultrafiltration rate is less than/equals 10 mL/kg/h in observation period

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	41	41
Median (Inter-Quartile Range) [proportion of sessions]	0.83	0.83

3. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight)
Description	Average interdialytic weight gain as percentage of patient's dry weight
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Average of interdialytic weight gain per patient for all haemodialysis sessions in each observation period

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	41	41
Mean (Standard Deviation) [% of dry weight]	2.76 (0.96)	2.68 (0.92)

4. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)
Description	Average interdialytic weight gain in kg
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Average of interdialytic weight gain per patient for all haemodialysis sessions in each observation period

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	41	41
Mean (Standard Deviation) [kg]	2.29 (0.74)	2.22 (0.71)

5. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%)
Description	Proportion of hemodialysis sessions in which interdialytic weight gain is less than/equals 4%
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Average of the proportion of hemodialysis sessions per patient in which interdialytic weight gain is less than/equals 4% in observation period

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	41	41
Median (Inter-Quartile Range) [proportion of sessions]	0.83	0.83

6. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight
Description	predialysis weight
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

average of the pre-dialysis clinic observed weights per patient in the observation period

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	41	41
Mean (Standard Deviation) [kg]	89.15 (23.30)	89.27 (23.34)

7. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure
Description	pre-dialysis supine systolic blood pressure
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

average of the clinic-observed pre-dialysis supine systolic blood pressures per patient in the observation period

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	41	41
Mean (Standard Deviation) [mmHg]	146.6 (18.4)	146.3 (19.6)

8. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure
Description	pre-dialysis supine diastolic blood pressure
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

average of the clinic-observed pre-dialysis supine diastolic blood pressures per patient in the observation period

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	41	41
Mean (Standard Deviation) [mmHg]	75.2 (14.8)	74.5 (15.2)

9. Secondary Outcome

Title	Patient Engagement With patientMpower App to Record Medication Adherence
Description	actual number of days medication adherence reported by patient on patientMpower app
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who started patientMpower observation period and recorded medicines adherence at least once

Arm/Group Title	All Patients
Arm/Group Description	All patients who started patientMpower observation period
Measure Participants	2
Mean (Full Range) [days]	18

10. Secondary Outcome

Title	Patient Engagement With patientMpower App to Record Blood Pressure.
Description	actual number of days blood pressure reported by patient on patientMpower app
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who started patientMpower observation period and who recorded blood pressure at least once

Arm/Group Title	All Patients
Arm/Group Description	All patients who started patientMpower observation period
Measure Participants	38
Mean (Standard Deviation) [days]	18 (8)

11. Secondary Outcome

Title	Patient Engagement With patientMpower App to Record Symptoms
Description	Actual number of days symptoms reported by patient on patientMpower application
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who started patientMpower observation period and who recorded symptoms at least once on patientMpower app

Arm/Group Title	All Patients
Arm/Group Description	All patients who started patientMpower observation period
Measure Participants	33
Mean (Standard Deviation) [days]	13 (8)

12. Secondary Outcome

Title	Patient Engagement With patientMpower App to Record Fluid Intake
Description	Actual number of days fluid intake reported by patients on patientMpower application
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who started patientMpower observation period and who recorded fluid intake at least once on patientMpower app

Arm/Group Title	All Patients
Arm/Group Description	All patients who started patientMpower observation period
Measure Participants	33
Mean (Standard Deviation) [days]	13 (8)

13. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis.
Description	number of patients requiring additional unscheduled hemodialysis sessions
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who started the sham or patientMpower observation period

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	43	43
Count of Participants [Participants]	2 4.7%	2 NaN

14. Secondary Outcome

Title	Patient Opinion on Utility and Acceptability of patientMpower Application
Description	Questionnaire-based assessment: 7 questions. [pMp = patientMpower intervention] using pMp helped me to take correct dose of my medicines every day using pMp gave me more confidence/greater sense of control in managing my health my preference for using pMp my difficulty rating in using pMp effect of using pMp on my well-being and daily life do I want to continue using pMp after study end did I like using pMp Possible responses Q1, Q2: strongly agree/agree/disagree/strongly disagree; Q3: yes/no preference/no; Q4: very easy/easy/difficult/very difficult; Q5: positive/negative; Q6: yes/no; Q7: 10-point linear scale: 1 (did not like at all) to 10 (liked a lot)
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who started the patientMpower observation period and provided a response to the questionnaire

Arm/Group Title	All Patients
Arm/Group Description	All patients who started patientMpower observation period
Measure Participants	23
pMp helped me take my correct medicines/day	12 27.9%
pMp gave me greater confidence/control	19 44.2%
preferred using pMp = yes	14 32.6%
pMp easy or very easy to use	21 48.8%
positive effect pMp on well-being/daily life = yes	19 44.2%
want to continue using pMp after study end = yes	18 41.9%
liked using pMp: score at least 8/10	15 34.9%

15. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility
Description	number of patients with at least 50% collapsibility
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who had measurement of inferior vena cava diameter assessed pre-dialysis

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	7	7
Count of Participants [Participants]	7 16.3%	6 NaN

16. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter
Description	longitudinal diameter
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who had measurement of inferior vena cava diameter assessed pre-dialysis

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	7	7
Mean (Standard Deviation) [cm]	1.7 (0.5)	1.8 (0.5)

17. Secondary Outcome

Title	Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter
Description	transverse diameter
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

All patients who had measurement of inferior vena cava diameter assessed pre-dialysis

Arm/Group Title	Sham	patientMpower
Arm/Group Description	sham observation period	patientMpower observation period
Measure Participants	7	7
Mean (Standard Deviation) [cm]	1.5 (0.6)	1.5 (0.6)

Adverse Events

Time Frame	Observation duration for sham observation period = 28 days for all patients who started sham observation period. Observation duration for patientMpower observation period = 28 days for all patients who started patientMpower observation period. Design was randomised 2 x 28 day crossover
Arm/Group Title	Sham Observation Period		patientMpower Observation Period
Arm/Group Description	All patients who started sham observation period		All patient who started patientMpower observation period
All Cause Mortality
	Sham Observation Period		patientMpower Observation Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/43 (0%)
Serious Adverse Events
	Sham Observation Period		patientMpower Observation Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/43 (2.3%)		2/43 (4.7%)
Cardiac disorders
hypertension	0/43 (0%)	0	1/43 (2.3%)	1
Injury, poisoning and procedural complications
alcohol withdrawal seizure	0/43 (0%)	0	1/43 (2.3%)	1
arteriovenous fistula thrombosis	0/43 (0%)	0	1/43 (2.3%)	1
Musculoskeletal and connective tissue disorders
leg fracture	1/43 (2.3%)	1	0/43 (0%)	0
Other (Not Including Serious) Adverse Events
	Sham Observation Period		patientMpower Observation Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		1/43 (2.3%)
General disorders
fall	0/43 (0%)	0	1/43 (2.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.