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

NCT03403491 | Completed Results

• 1 other identifier: Hemodialysis patientMpower02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Dialysis

Outcome Measures

Primary Outcomes (1)

• Patient Engagement With patientMpower App to Record Body Weight

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

  28 days

Secondary Outcomes (16)

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

  28 days

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

  28 days

• Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)

  28 days

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

  28 days

• Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight

  28 days

Study Arms (2)

Sequence 1

OTHER

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; Other: sham application

Sequence 2

OTHER

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; Other: sham application

Interventions

patientMpower application OTHER

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

Sequence 1; Sequence 2

sham application OTHER

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

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• patientMpower Ltd.: lead
• Health Service Executive, Ireland: collaborator

Study Sites (1)

Renal Dialysis Centre, Beaumont Hospital

Dublin, Ireland

Location

Related Publications (1)

• Sandys V, Bhat L, O'Hare E, Hudson A, O'Seaghdha CM, Sexton DJ. Interpretability of Home Blood Pressure Measurements in Haemodialysis A Post Hoc Analysis of a Randomised Cross-Over Study. Nephrology (Carlton). 2025 Sep;30(9):e70112. doi: 10.1111/nep.70112.

  PMID: 40854574 DERIVED

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: patientMpower Ltd

colin@patientmpower.com

+353872599131

Study Officials

• Renal Dialysis Centre

  Beaumont Hospital, Dublin 9, Ireland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 18, 2018
• Study Start: November 7, 2018
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)