Renal DialysisNCT03403491
Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis
A study testing patientMpower application in people with Renal Dialysis, run by patientMpower Ltd. at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- patientMpower application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteIreland
- Study dates
- 7 Nov 2018to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Renal Dialysis
- Being tested
- patientMpower application, sham application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patientMpower applicationOther
electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms
sham applicationOther
dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: patientMpower application; Other: sham application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Engagement With patientMpower App to Record Body Weight
Actual number of days body weight reported by patient on patientMpower app
Measured: 28 days
Secondary outcomes (16)
Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h)
Proportion of hemodialysis sessions in which ultrafiltration rate is less than/equals 10mL/kg/h
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight)
Average interdialytic weight gain as percentage of patient's dry weight
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)
Average interdialytic weight gain in kg
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%)
Proportion of hemodialysis sessions in which interdialytic weight gain is less than/equals 4%
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight
predialysis weight
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure
pre-dialysis supine systolic blood pressure
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure
pre-dialysis supine diastolic blood pressure
Measured: 28 days
Patient Engagement With patientMpower App to Record Medication Adherence
actual number of days medication adherence reported by patient on patientMpower app
Measured: 28 days
Patient Engagement With patientMpower App to Record Blood Pressure.
actual number of days blood pressure reported by patient on patientMpower app
Measured: 28 days
Patient Engagement With patientMpower App to Record Symptoms
Actual number of days symptoms reported by patient on patientMpower application
Measured: 28 days
Patient Engagement With patientMpower App to Record Fluid Intake
Actual number of days fluid intake reported by patients on patientMpower application
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis.
number of patients requiring additional unscheduled hemodialysis sessions
Measured: 28 days
Patient Opinion on Utility and Acceptability of patientMpower Application
Questionnaire-based assessment: 7 questions. [pMp = patientMpower intervention]
- using pMp helped me to take correct dose of my medicines every day
- using pMp gave me more confidence/greater sense of control in managing my health
- my preference for using pMp
- my difficulty rating in using pMp
- effect of using pMp on my well-being and daily life
- do I want to continue using pMp after study end
- 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)
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility
number of patients with at least 50% collapsibility
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter
longitudinal diameter
Measured: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter
transverse diameter
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start7 Nov 2018
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- patientMpower Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health Service Executive, Ireland
- Responsible party
- Sponsor
- Investigators
- Renal Dialysis Centre, Principal investigator, Beaumont Hospital, Dublin 9, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403491
- Sponsor's protocol ID
- Hemodialysis patientMpower02
- Status last verified
- Jun 2020
- First submitted
- 5 Jan 2018
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40854574
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03403491
- Acronym / sponsor ID
- Hemodialysis patientMpower02
- Conditions
- Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- patientMpower Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Health Service Executive, Ireland
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Other: patientMpower application, Other: sham applicationUsual 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. |
| Sequence 2 | Other | Other: patientMpower application, Other: sham applicationUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patientMpower applicationelectronic health journal for patient to record weight, blood pressure, medication adherence and symptoms | Other | Sequence 1, Sequence 2 |
| sham applicationdummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms | Other | Sequence 1, Sequence 2 |
Primary outcome
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
16 secondary outcomes
Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h)
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight)
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute)
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%)
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure
Time frame: 28 days
Patient Engagement With patientMpower App to Record Medication Adherence
Time frame: 28 days
Patient Engagement With patientMpower App to Record Blood Pressure.
Time frame: 28 days
Patient Engagement With patientMpower App to Record Symptoms
Time frame: 28 days
Patient Engagement With patientMpower App to Record Fluid Intake
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis.
Time frame: 28 days
Patient Opinion on Utility and Acceptability of patientMpower Application
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter
Time frame: 28 days
Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40854574Sandys 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renal Dialysis Centre principal investigator
Beaumont Hospital, Dublin 9, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patientMpower application in people with Renal Dialysis, run by patientMpower Ltd. at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Engagement With patientMpower App to Record Body Weight (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.