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| Name | Class |
|---|---|
| Health Service Executive, Ireland | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patientMpower application | Other | electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Engagement With patientMpower App to Record Body Weight | Actual number of days body weight reported by patient on patientMpower app | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight) |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renal Dialysis Centre | Beaumont Hospital, Dublin 9, Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal Dialysis Centre, Beaumont Hospital | Dublin | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40854574 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. patientMpower application: electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms sham application: dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms |
| FG001 | 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. patientMpower application: electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms sham application: dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All randomised patients who started the study observations
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients who started patientMpower observation period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Engagement With patientMpower App to Record Body Weight | Actual number of days body weight reported by patient on patientMpower app | All patients who started patientMpower observation period and who recorded weight at least once | Posted | Mean | Standard Deviation | days | 28 days |
|
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Observation duration for sham observation period = 28 days for all patients who started sham observation period. Observation duration for patientMpower observation period = 28 days for all patients who started patientMpower observation period. Design was randomised 2 x 28 day crossover
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Observation Period | All patients who started sham observation period | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| leg fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fall | General disorders | Non-systematic Assessment | fell off weighing scales twice |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | patientMpower Ltd | +353872599131 | colin@patientmpower.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2018 | Mar 5, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Description | Jun 26, 2019 | Mar 5, 2020 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Appendix 1 | Jun 26, 2019 | Mar 5, 2020 | SAP_002.pdf |
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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.
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| sham application | Other | dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms |
|
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) | Average interdialytic weight gain in kg | 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% | 28 days |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight | predialysis weight | 28 days |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure | pre-dialysis supine systolic blood pressure | 28 days |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure | pre-dialysis supine diastolic blood pressure | 28 days |
| Patient Engagement With patientMpower App to Record Medication Adherence | actual number of days medication adherence reported by patient on patientMpower app | 28 days |
| Patient Engagement With patientMpower App to Record Blood Pressure. | actual number of days blood pressure reported by patient on patientMpower app | 28 days |
| Patient Engagement With patientMpower App to Record Symptoms | Actual number of days symptoms reported by patient on patientMpower application | 28 days |
| Patient Engagement With patientMpower App to Record Fluid Intake | 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. | number of patients requiring additional unscheduled hemodialysis sessions | 28 days |
| Patient Opinion on Utility and Acceptability of patientMpower Application | Questionnaire-based assessment: 7 questions. [pMp = patientMpower intervention]
| 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 | 28 days |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter | longitudinal diameter | 28 days |
| Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter | transverse diameter | 28 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| time since first-ever hemodialysis | Mean | Standard Deviation | years |
|
| vascular access modality | Count of Participants | Participants |
|
|
| Secondary | 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 | Average of the proportion of hemodialysis sessions per patient in which ultrafiltration rate is less than/equals 10 mL/kg/h in observation period | Posted | Median | Inter-Quartile Range | proportion of sessions | 28 days |
|
|
|
| Secondary | 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 | Average of interdialytic weight gain per patient for all haemodialysis sessions in each observation period | Posted | Mean | Standard Deviation | % of dry weight | 28 days |
|
|
|
| Secondary | Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute) | Average interdialytic weight gain in kg | Average of interdialytic weight gain per patient for all haemodialysis sessions in each observation period | Posted | Mean | Standard Deviation | kg | 28 days |
|
|
|
| Secondary | 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% | Average of the proportion of hemodialysis sessions per patient in which interdialytic weight gain is less than/equals 4% in observation period | Posted | Median | Inter-Quartile Range | proportion of sessions | 28 days |
|
|
|
| Secondary | Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight | predialysis weight | average of the pre-dialysis clinic observed weights per patient in the observation period | Posted | Mean | Standard Deviation | kg | 28 days |
|
|
|
| Secondary | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure | pre-dialysis supine systolic blood pressure | average of the clinic-observed pre-dialysis supine systolic blood pressures per patient in the observation period | Posted | Mean | Standard Deviation | mmHg | 28 days |
|
|
|
| Secondary | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure | pre-dialysis supine diastolic blood pressure | average of the clinic-observed pre-dialysis supine diastolic blood pressures per patient in the observation period | Posted | Mean | Standard Deviation | mmHg | 28 days |
|
|
|
| Secondary | Patient Engagement With patientMpower App to Record Medication Adherence | actual number of days medication adherence reported by patient on patientMpower app | All patients who started patientMpower observation period and recorded medicines adherence at least once | Posted | Mean | Full Range | days | 28 days |
|
|
|
| Secondary | Patient Engagement With patientMpower App to Record Blood Pressure. | actual number of days blood pressure reported by patient on patientMpower app | All patients who started patientMpower observation period and who recorded blood pressure at least once | Posted | Mean | Standard Deviation | days | 28 days |
|
|
|
| Secondary | Patient Engagement With patientMpower App to Record Symptoms | Actual number of days symptoms reported by patient on patientMpower application | All patients who started patientMpower observation period and who recorded symptoms at least once on patientMpower app | Posted | Mean | Standard Deviation | days | 28 days |
|
|
|
| Secondary | Patient Engagement With patientMpower App to Record Fluid Intake | Actual number of days fluid intake reported by patients on patientMpower application | All patients who started patientMpower observation period and who recorded fluid intake at least once on patientMpower app | Posted | Mean | Standard Deviation | days | 28 days |
|
|
|
| Secondary | Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis. | number of patients requiring additional unscheduled hemodialysis sessions | All patients who started the sham or patientMpower observation period | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Patient Opinion on Utility and Acceptability of patientMpower Application | Questionnaire-based assessment: 7 questions. [pMp = patientMpower intervention]
| All patients who started the patientMpower observation period and provided a response to the questionnaire | Posted | Number | participants | 28 days |
|
|
|
| Secondary | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility | number of patients with at least 50% collapsibility | All patients who had measurement of inferior vena cava diameter assessed pre-dialysis | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter | longitudinal diameter | All patients who had measurement of inferior vena cava diameter assessed pre-dialysis | Posted | Mean | Standard Deviation | cm | 28 days |
|
|
|
| Secondary | Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter | transverse diameter | All patients who had measurement of inferior vena cava diameter assessed pre-dialysis | Posted | Mean | Standard Deviation | cm | 28 days |
|
|
|
| 43 |
| 1 |
| 43 |
| 0 |
| 43 |
| EG001 | patientMpower Observation Period | All patient who started patientMpower observation period | 0 | 43 | 2 | 43 | 1 | 43 |
| hypertension | Cardiac disorders | Non-systematic Assessment | alcohol withdrawal seizure reported in same patient |
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| alcohol withdrawal seizure | Injury, poisoning and procedural complications | Non-systematic Assessment | hypertension reported in same patient |
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| arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
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| pMp easy or very easy to use |
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| positive effect pMp on well-being/daily life = yes |
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| want to continue using pMp after study end = yes |
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| liked using pMp: score at least 8/10 |
|