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

patientMpower Ltd. · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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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).
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