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

June 2, 2020 updated by: patientMpower Ltd.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
28 days
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
28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)
Time Frame: 28 days
Average interdialytic weight gain in kg
28 days
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%
28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight
Time Frame: 28 days
predialysis weight
28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure
Time Frame: 28 days
pre-dialysis supine systolic blood pressure
28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure
Time Frame: 28 days
pre-dialysis supine diastolic blood pressure
28 days
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
28 days
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
28 days
Patient Engagement With patientMpower App to Record Symptoms
Time Frame: 28 days
Actual number of days symptoms reported by patient on patientMpower application
28 days
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
28 days
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
28 days
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)
28 days
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
28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter
Time Frame: 28 days
longitudinal diameter
28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter
Time Frame: 28 days
transverse diameter
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
patientMpower Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Service Executive, Ireland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Renal Dialysis Centre, Beaumont Hospital, Dublin 9, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hemodialysis patientMpower02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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