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

NCT03403491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-06-16

Study results available
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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).

Conditions

  • Renal Dialysis

Interventions

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

Sponsors & Collaborators

  • Health Service Executive, Ireland

    collaborator OTHER

  • patientMpower Ltd.

    lead INDUSTRY

Principal Investigators

  • Renal Dialysis Centre · Beaumont Hospital, Dublin 9, Ireland

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2019-03-08
Completion
2019-03-08

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03403491 on ClinicalTrials.gov