JMIR Publications

ABSTRACT

Background:

Heart failure (HF) patients are at highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately, but the impact of TM targeted for patients recently discharged from hospital for whom TM might have the biggest benefit, is still unknown. Medly, a mobile-based TM system, is currently being used as HF standard of care at a large Canadian hospital, and may be an effective tool for HF management of patients recently discharged from hospital.

Objective:

The objective of the Medly-AID (After an Incidence of acute Decompensation) trial is to determine the effect of Medly on the self-care and quality of life of HF patients who have been recently discharged from hospital after an HF-related decompensation.

Methods:

A multisite multi-methods randomized controlled trial (RCT) will be conducted at two academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of HF patients who have been discharged from hospital for HF-related decompensation within the two weeks prior to recruitment. The trial will include 144 HF participants (74 in each control and intervention groups). Control patients will receive standard of care, while patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will take daily weight, blood pressure, and heart rate and answer symptom questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and real-time alerts to their healthcare providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires, Self-Care of Heart Failure Index, EuroQol, and the Kansas City Cardiomyopathy Questionnaire. Secondary outcome measures for this study include cost of healthcare services used and health outcomes.

Results:

Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020.

Conclusions:

This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. Clinical Trial: ClinicalTrials.gov Identifier: NCT03358303