Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 16, 2021
Date Accepted: Dec 8, 2021
Rehabilitation at home using mobile health in older adults after hospitalization for ischemic heart disease: Design of the RESILIENT Randomized Controlled Trial
ABSTRACT
Background:
Participation in ambulatory cardiac rehabilitation (CR) remains low, especially among older adults. While mobile health CR (mHealth-CR) provides a novel opportunity to deliver care, age specific impairments may limit older adults’ uptake, and efficacy data are currently lacking.
Objective:
The primary objective of RESILIENT is to test whether mHealth-CR improves functional capacity, as measured my 6 minute walk distance (6MWD), compared with usual care. We hypothesize that 6MWD will be significantly improved among participants receiving the study intervention.
Methods:
The RESILIENT trial (NCT03978130) is a multicenter randomized clinical trial that is enrolling patients age ≥65 with ischemic heart disease in a 3:1 ratio to either intervention (mHealth-CR) or control (usual care), with a target sample size of 400 participants. mHealth-CR consists of a commercially available mHealth software platform coupled with weekly exercise therapist sessions to review progress and set new activity goals. The primary outcome is change in functional mobility (6 minute walk distance) which is measured at baseline and 3 months. Secondary outcomes are health status, goal attainment, hospital readmission, and mortality. Among intervention participants, engagement with the mHealth-CR platform will be analyzed to understand characteristics that determine different patterns of use (e.g. persistent high engagement, declining engagement).
Results:
As of December 2021, the RESILIENT trial has enrolled 116 participants. Enrollment is projected to continue until October 2023. Trial results are expected to be reported in 2024.
Conclusions:
The RESILIENT trial will generate important evidence about the efficacy of mHealth-CR among older adults in multiple domains, as well as characteristics that determine sustained use of mHealth-CR. These findings will help in designing future precision medicine approaches to mHealth implementation in older adults. This knowledge is especially important in light of the COVID-19 pandemic which has shifted much of healthcare to the virtual setting. Clinical Trial: Trial is registered under: NCT03978130
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