Clinical trial NCT03403491: Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Lead sponsor: patientMpower Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Health Service Executive, Ireland
First posted: 2018-01-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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).

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).

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient Engagement With patientMpower App to Record Body Weight
timeFrame: 28 days
Secondary outcomes:
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h)
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight)
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%)
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure
timeFrame: 28 days
measure: Patient Engagement With patientMpower App to Record Medication Adherence
timeFrame: 28 days
measure: Patient Engagement With patientMpower App to Record Blood Pressure.
timeFrame: 28 days
measure: Patient Engagement With patientMpower App to Record Symptoms
timeFrame: 28 days
measure: Patient Engagement With patientMpower App to Record Fluid Intake
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis.
timeFrame: 28 days
measure: Patient Opinion on Utility and Acceptability of patientMpower Application
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter
timeFrame: 28 days
measure: Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter
timeFrame: 28 days
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Renal Dialysis Centre, Beaumont Hospital
Study officials:
affiliation: Beaumont Hospital, Dublin 9, Ireland
name: Renal Dialysis Centre
role: PRINCIPAL_INVESTIGATOR
References: