NCT03403491

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: patientMpower Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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).

Conditions

• Renal Dialysis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-07
• Primary completion: 2019-03-08
• Completion: 2019-03-08
• First posted: 2018-01-18
• Last updated: 2020-06-16
• Results posted: 2020-06-16

Locations

1 site across 1 country: Ireland