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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03403491
Recruitment Status : Completed
First Posted : January 18, 2018
Results First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Health Service Executive, Ireland
Information provided by (Responsible Party):
patientMpower Ltd.

Study Description
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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).


Condition or disease Intervention/treatment Phase
Renal Dialysis Other: patientMpower application Other: sham application Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : March 8, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sequence 1
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
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
Sequence 2
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Patient Engagement With patientMpower App to Record Body Weight [ Time Frame: 28 days ]
    Actual number of days body weight reported by patient on patientMpower app


Secondary Outcome Measures :
  1. Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h) [ Time Frame: 28 days ]
    Proportion of hemodialysis sessions in which ultrafiltration rate is less than/equals 10mL/kg/h

  2. Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight) [ Time Frame: 28 days ]
    Average interdialytic weight gain as percentage of patient's dry weight

  3. Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute) [ Time Frame: 28 days ]
    Average interdialytic weight gain in kg

  4. Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%) [ Time Frame: 28 days ]
    Proportion of hemodialysis sessions in which interdialytic weight gain is less than/equals 4%

  5. Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight [ Time Frame: 28 days ]
    predialysis weight

  6. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure [ Time Frame: 28 days ]
    pre-dialysis supine systolic blood pressure

  7. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure [ Time Frame: 28 days ]
    pre-dialysis supine diastolic blood pressure

  8. Patient Engagement With patientMpower App to Record Medication Adherence [ Time Frame: 28 days ]
    actual number of days medication adherence reported by patient on patientMpower app

  9. Patient Engagement With patientMpower App to Record Blood Pressure. [ Time Frame: 28 days ]
    actual number of days blood pressure reported by patient on patientMpower app

  10. Patient Engagement With patientMpower App to Record Symptoms [ Time Frame: 28 days ]
    Actual number of days symptoms reported by patient on patientMpower application

  11. Patient Engagement With patientMpower App to Record Fluid Intake [ Time Frame: 28 days ]
    Actual number of days fluid intake reported by patients on patientMpower application

  12. Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis. [ Time Frame: 28 days ]
    number of patients requiring additional unscheduled hemodialysis sessions

  13. Patient Opinion on Utility and Acceptability of patientMpower Application [ Time Frame: 28 days ]

    Questionnaire-based assessment: 7 questions. [pMp = patientMpower intervention]

    1. using pMp helped me to take correct dose of my medicines every day
    2. using pMp gave me more confidence/greater sense of control in managing my health
    3. my preference for using pMp
    4. my difficulty rating in using pMp
    5. effect of using pMp on my well-being and daily life
    6. do I want to continue using pMp after study end
    7. did I like using pMp Possible responses Q1, Q2: strongly agree/agree/disagree/strongly disagree; Q3: yes/no preference/no; Q4: very easy/easy/difficult/very difficult; Q5: positive/negative; Q6: yes/no; Q7: 10-point linear scale: 1 (did not like at all) to 10 (liked a lot)

  14. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility [ Time Frame: 28 days ]
    number of patients with at least 50% collapsibility

  15. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter [ Time Frame: 28 days ]
    longitudinal diameter

  16. Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter [ Time Frame: 28 days ]
    transverse diameter


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403491


Locations
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Ireland
Renal Dialysis Centre, Beaumont Hospital
Dublin, Ireland
Sponsors and Collaborators
patientMpower Ltd.
Health Service Executive, Ireland
Investigators
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Principal Investigator: Renal Dialysis Centre Beaumont Hospital, Dublin 9, Ireland
  Study Documents (Full-Text)

Documents provided by patientMpower Ltd.:
Study Protocol  [PDF] December 20, 2018
Statistical Analysis Plan: Description  [PDF] June 26, 2019
Statistical Analysis Plan: Appendix 1  [PDF] June 26, 2019

More Information
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Responsible Party: patientMpower Ltd.
ClinicalTrials.gov Identifier: NCT03403491    
Other Study ID Numbers: Hemodialysis patientMpower02
First Posted: January 18, 2018    Key Record Dates
Results First Posted: June 16, 2020
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No