Clinical Trials Logo

Clinical 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. 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03403491
Study type Interventional
Source patientMpower Ltd.
Contact
Status Completed
Phase N/A
Start date November 7, 2018
Completion date March 8, 2019

See also
  Status Clinical Trial Phase
Completed NCT05189795 - The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Completed NCT01125202 - Intervention to Reduce Dietary Sodium in Hemodialysis N/A
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00806130 - Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
Completed NCT00753116 - Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension Phase 1
Completed NCT05718765 - The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients N/A
Completed NCT03250715 - Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure N/A
Completed NCT05469620 - Adaptive Nutrition Therapy in Hemodialysis N/A
Completed NCT03536858 - Social Networks and Renal Education: Promoting Transplantation N/A
Completed NCT00824837 - Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane Phase 1/Phase 2
Terminated NCT02495662 - The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation Phase 2
Completed NCT01179620 - Certoparin in Renal Patients Undergoing Hemodialysis Phase 3
Completed NCT01017276 - A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis Phase 3
Active, not recruiting NCT04466865 - A Communication Tool to Assist Older Adults Facing Dialysis Choices N/A
Recruiting NCT03782519 - Quality of Life of Frail Aged Patients in Incremental Hemodialysis N/A
Recruiting NCT02843334 - Study of the Prevalence of Fabry Disease in French Dialysis Patients N/A
Recruiting NCT02545530 - Transdermal Clonidine in Chronic Hemodialysis Patients N/A
Completed NCT00892749 - Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis Phase 3
Completed NCT00649298 - A Clinical Trial of IntensiVE Dialysis Phase 4
Completed NCT05833451 - Reiki in Symptom Management of Hemodialysis Patients N/A