N/A
Completed N=43
Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis
Renal Dialysis
Source: ClinicalTrials.gov NCT03403491 ↗
Enrolled (actual)
43
Serious AEs
3.5%
Results posted
Jun 2020
Primary outcomePrimary: Patient Engagement With patientMpower App to Record Body Weight — 24 days
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Engagement With patientMpower App to Record Body Weight |
24 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Ultrafiltration Rate (Proportion </= 10mL/kg/h) |
0.83; 0.83 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Relative to Dry Weight) |
2.76; 2.68 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Absolute) |
2.29; 2.22 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Interdialytic Weight Gain (Proportion </= 4%) |
0.83; 0.83 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Predialysis Weight |
89.15; 89.27 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Systolic Blood Pressure |
146.6; 146.3 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Diastolic Blood Pressure |
75.2; 74.5 | — |
| SECONDARY Patient Engagement With patientMpower App to Record Medication Adherence |
18 | — |
| SECONDARY Patient Engagement With patientMpower App to Record Blood Pressure. |
18 | — |
| SECONDARY Patient Engagement With patientMpower App to Record Symptoms |
13 | — |
| SECONDARY Patient Engagement With patientMpower App to Record Fluid Intake |
13 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Requirement for Additional Unscheduled Hemodialysis. |
2; 2 | — |
| SECONDARY Patient Opinion on Utility and Acceptability of patientMpower Application |
12; 19; 14; 21; 19; 18 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Collapsibility |
7; 6 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Longitudinal Diameter |
1.7; 1.8 | — |
| SECONDARY Effect of patientMpower App [+Digital Scales & BP Monitor] on Pre-dialysis Inferior Vena Cava Transverse Diameter |
1.5; 1.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT03403491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.