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Clinical Studies

patientMpower Publishes New Data on Hemodialysis Randomized Control Trial

By November 19, 2019May 1st, 2021No Comments

patientMpower has joined forces with Beaumont Hospital Kidney Centre to conduct a pilot scale study (NCT03403491) in ambulatory haemodialysis patients treated in a clinical setting. This study aimed to evaluate the patientMpower intervention (pMp) and its features such as mobile digital health intervention, digital weighing scales and blood pressure (BP) monitoring. Patient-reported weight and BP were captured by wireless connection to pMp (cellular or Bluetooth). 43 patients were recruited and among this group there were 28 males and 15 females.

The method used in this pilot scale study was open-label, randomised and included a random 2 x 28-day crossover comparison of patientMpower intervention versus a sham intervention. During the patientMpower usage period, patients were asked to record weight, BP, symptoms, fluid intake & medicines adherence every day on the app. With this subjective data, patientMpower then calculated and displayed weight gain relative to individualised target (dry) weight to each patient. An algorithm within pMp delivered tailored feedback messages (dependent on actual weight gain since the last dialysis session) to optimise fluid intake between dialysis sessions.

The primary endpoint of this study was patient engagement with the patientMpower application. Engagement in this study was high and all patients recorded weight with 35 (81%) recording weight on ≥21 days of the patientMopower period. The secondary endpoints of this study include patient opinion and effect of patientMpower on patient volume control. In order to obtain patient opinion, patients were asked to complete and online survey to provide feedback and their personal opinion of patientMpower.

We would like to thank the patients who took part in this study and have generously contributed their time and data.The study met its primary endpoint, demonstrating high levels of patient engagement and safety with the pMp intervention. The high engagement by these patients suggests that this methodological approach could be useful in future studies of optimisation of dry weight estimation and/or fluid intake. While no effect of the pMp intervention on haemodialysis parameters was observed in this exploratory analysis, the study was underpowered to test this. Larger studies in a higher risk populations (e.g. new initiation on dialysis, home dialysis or patients with known poor volume control) are warranted.