Medly Research on International Implementation Success and Clinical Effectiveness [Medly-RISE] (Trial Not Registered)

The technological intervention underpinning the Medly Program is the digital therapeutic Medly20, a smartphone app with a built-in rules-based algorithm that provides heart failure (HF) patients with personalized self-care feedback based on daily entry of physiological parameters (e.g., weight, blood pressure, and heart rate) and symptoms from home, and continuous monitoring by their healthcare team through an integrated clinician dashboard. The clinical effectiveness and implementation of Medly have been studied through randomised controlled trials, feasibility trials, and observation studies over the past decade, but only in Ontario, Canada. The primary research aim is to determine the implementation factors and implementation outcomes of Medly for HF management at participating national and international hospitals in Alberta (Canada), Australia, and the United Kingdom.

Trial phase

Phase 2

Trial participation type

This trial is for clinical research of something other than a drug or device.

Principal investigator

A/Prof Ingrid Hopper

Key inclusion data

Inclusion criteria: A. To participate in the study, intervention arm participants must meet the following inclusion criteria: 1. Has a heart failure diagnosis AND, 2. 18 years of age or older AND, 3. Considered at risk for decompensation: Discharged from hospital or discharged from an outpatient diuretic program at a participating study site within 8 weeks of recruitment into the study, 4. Able to comply with use of the Medly program and applicable peripheral devices (e.g., able to stand on the weight scale, able to answer symptom questions, etc.), and 5. Able to complete study questionnaires in English either independently or with the assistance of a caregiver. B. In order to participate in the study, control arm participants must meet the following inclusion criteria: 1. Has a heart failure diagnosis AND, 2. 18 years of age or older AND, 3. Considered at risk for decompensation: Discharged from hospital or discharged from an outpatient diuretic program at a participating study site within 8 weeks of recruitment into the study, 4. Able to comply with use of the Medly program and applicable peripheral devices (e.g., able to stand on the weight scale, able to answer symptom questions, etc.) 5. Able to complete study questionnaires in English either independently or with the assistance of a caregiver C. To participate in the study, healthcare providers (HCP) and Staff participants must meet the following inclusion criteria: 1. Be a practicing HCP, decision maker, and/or support staff at participating study site-affiliated hospital(s) 2. Able to read, write, and speak English Exclusion criteria: 1. Patients who are discharged from hospital with the intent to be admitted to a long-term care facility and/or who are receiving end-of-life care. 2. Control Arm Patient Participants are excluded from participating in the intervention arm of the study. 3. No exclusion criteria have been defined for HCP and Staff Participants.