Trial Outcomes & Findings for Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis (NCT NCT03403491)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

28 days

Results posted on

2020-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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	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. 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
Overall Study STARTED	20	23
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=43 Participants All patients who started patientMpower observation period
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	51.42 years STANDARD_DEVIATION 13.98 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race/Ethnicity, Customized white	39 Participants n=5 Participants
Race/Ethnicity, Customized black	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Region of Enrollment Ireland	43 participants n=5 Participants
time since first-ever hemodialysis	3.44 years STANDARD_DEVIATION 3.71 • n=5 Participants
vascular access modality permcath	25 Participants n=5 Participants
vascular access modality arteriovenous fistula	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

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

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

Outcome measures

Outcome measures
Measure	All Patients n=43 Participants All patients who started patientMpower observation period	patientMpower patientMpower observation period
Patient Engagement With patientMpower App to Record Body Weight	24 days Standard Deviation 6	—

SECONDARY outcome

Timeframe: 28 days

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

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

Outcome measures

Outcome measures
Measure	All Patients n=41 Participants All patients who started patientMpower observation period	patientMpower n=41 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h)	0.83 proportion of sessions Interval 0.25 to 1.0	0.83 proportion of sessions Interval 0.44 to 1.0

SECONDARY outcome

Timeframe: 28 days

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

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

Outcome measures

Outcome measures
Measure	All Patients n=41 Participants All patients who started patientMpower observation period	patientMpower n=41 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight)	2.76 % of dry weight Standard Deviation 0.96	2.68 % of dry weight Standard Deviation 0.92

SECONDARY outcome

Timeframe: 28 days

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

Average interdialytic weight gain in kg

Outcome measures

Outcome measures
Measure	All Patients n=41 Participants All patients who started patientMpower observation period	patientMpower n=41 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)	2.29 kg Standard Deviation 0.74	2.22 kg Standard Deviation 0.71

SECONDARY outcome

Timeframe: 28 days

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

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

Outcome measures

Outcome measures
Measure	All Patients n=41 Participants All patients who started patientMpower observation period	patientMpower n=41 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%)	0.83 proportion of sessions Interval 0.67 to 1.0	0.83 proportion of sessions Interval 0.67 to 1.0

SECONDARY outcome

Timeframe: 28 days

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

predialysis weight

Outcome measures

Outcome measures
Measure	All Patients n=41 Participants All patients who started patientMpower observation period	patientMpower n=41 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight	89.15 kg Standard Deviation 23.30	89.27 kg Standard Deviation 23.34

SECONDARY outcome

Timeframe: 28 days

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

pre-dialysis supine systolic blood pressure

Outcome measures

Outcome measures
Measure	All Patients n=41 Participants All patients who started patientMpower observation period	patientMpower n=41 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure	146.6 mmHg Standard Deviation 18.4	146.3 mmHg Standard Deviation 19.6

SECONDARY outcome

Timeframe: 28 days

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

pre-dialysis supine diastolic blood pressure

Outcome measures

Outcome measures
Measure	All Patients n=41 Participants All patients who started patientMpower observation period	patientMpower n=41 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure	75.2 mmHg Standard Deviation 14.8	74.5 mmHg Standard Deviation 15.2

SECONDARY outcome

Timeframe: 28 days

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

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

Outcome measures

Outcome measures
Measure	All Patients n=2 Participants All patients who started patientMpower observation period	patientMpower patientMpower observation period
Patient Engagement With patientMpower App to Record Medication Adherence	18 days Interval 16.0 to 21.0	—

SECONDARY outcome

Timeframe: 28 days

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

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

Outcome measures

Outcome measures
Measure	All Patients n=38 Participants All patients who started patientMpower observation period	patientMpower patientMpower observation period
Patient Engagement With patientMpower App to Record Blood Pressure.	18 days Standard Deviation 8	—

SECONDARY outcome

Timeframe: 28 days

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

Actual number of days symptoms reported by patient on patientMpower application

Outcome measures

Outcome measures
Measure	All Patients n=33 Participants All patients who started patientMpower observation period	patientMpower patientMpower observation period
Patient Engagement With patientMpower App to Record Symptoms	13 days Standard Deviation 8	—

SECONDARY outcome

Timeframe: 28 days

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

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

Outcome measures

Outcome measures
Measure	All Patients n=33 Participants All patients who started patientMpower observation period	patientMpower patientMpower observation period
Patient Engagement With patientMpower App to Record Fluid Intake	13 days Standard Deviation 8	—

SECONDARY outcome

Timeframe: 28 days

Population: All patients who started the sham or patientMpower observation period

number of patients requiring additional unscheduled hemodialysis sessions

Outcome measures

Outcome measures
Measure	All Patients n=43 Participants All patients who started patientMpower observation period	patientMpower n=43 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis.	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 28 days

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

Questionnaire-based assessment: 7 questions. \[pMp = patientMpower intervention\] 1. using pMp helped me to take correct dose of my medicines every day 2. using pMp gave me more confidence/greater sense of control in managing my health 3. my preference for using pMp 4. my difficulty rating in using pMp 5. effect of using pMp on my well-being and daily life 6. do I want to continue using pMp after study end 7. 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)

Outcome measures

Outcome measures
Measure	All Patients n=23 Participants All patients who started patientMpower observation period	patientMpower patientMpower observation period
Patient Opinion on Utility and Acceptability of patientMpower Application pMp helped me take my correct medicines/day	12 participants	—
Patient Opinion on Utility and Acceptability of patientMpower Application pMp gave me greater confidence/control	19 participants	—
Patient Opinion on Utility and Acceptability of patientMpower Application preferred using pMp = yes	14 participants	—
Patient Opinion on Utility and Acceptability of patientMpower Application pMp easy or very easy to use	21 participants	—
Patient Opinion on Utility and Acceptability of patientMpower Application positive effect pMp on well-being/daily life = yes	19 participants	—
Patient Opinion on Utility and Acceptability of patientMpower Application want to continue using pMp after study end = yes	18 participants	—
Patient Opinion on Utility and Acceptability of patientMpower Application liked using pMp: score at least 8/10	15 participants	—

SECONDARY outcome

Timeframe: 28 days

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

number of patients with at least 50% collapsibility

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants All patients who started patientMpower observation period	patientMpower n=7 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 28 days

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

longitudinal diameter

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants All patients who started patientMpower observation period	patientMpower n=7 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter	1.7 cm Standard Deviation 0.5	1.8 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 28 days

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

transverse diameter

Outcome measures

Outcome measures
Measure	All Patients n=7 Participants All patients who started patientMpower observation period	patientMpower n=7 Participants patientMpower observation period
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter	1.5 cm Standard Deviation 0.6	1.5 cm Standard Deviation 0.6

Adverse Events

Sham Observation Period

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

patientMpower Observation Period

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sham Observation Period n=43 participants at risk All patients who started sham observation period	patientMpower Observation Period n=43 participants at risk All patient who started patientMpower observation period
Musculoskeletal and connective tissue disorders leg fracture	2.3% 1/43 • Number of events 1 • 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	0.00% 0/43 • 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
Cardiac disorders hypertension	0.00% 0/43 • 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	2.3% 1/43 • Number of events 1 • 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
Injury, poisoning and procedural complications alcohol withdrawal seizure	0.00% 0/43 • 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	2.3% 1/43 • Number of events 1 • 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
Injury, poisoning and procedural complications arteriovenous fistula thrombosis	0.00% 0/43 • 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	2.3% 1/43 • Number of events 1 • 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

Other adverse events

Other adverse events
Measure	Sham Observation Period n=43 participants at risk All patients who started sham observation period	patientMpower Observation Period n=43 participants at risk All patient who started patientMpower observation period
General disorders fall	0.00% 0/43 • 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	2.3% 1/43 • Number of events 2 • 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

Additional Information

Chief Scientific Officer

patientMpower Ltd

Phone: +353872599131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place