CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
patientMpower application +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03403491
NCT03403491N/ACompleted

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

patientMpower Ltd.·interventional·Posted Jan 18, 2018·Updated Jun 16, 2020

In Brief

A clinical study evaluating patientMpower application and sham application for Renal Dialysis. Completed, enrolled 43 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Dialysis
CountriesIreland

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 18, 2018
Enrollment StartNov 7, 2018
Primary CompletionMar 8, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.5 years ago

Interventions

patientMpower applicationother

electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms

sham applicationother

dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms