Rehabilitation Using Mobile Health for Older Adults With Ischemic Heart Disease in the Home Setting (RESILIENT): Protocol for a Randomized Controlled Trial

John A Dodson, Antoinette Schoenthaler, Greg Sweeney, Ana Fonceva, Alicia Pierre, Jonathan Whiteson, Barbara George, Kevin Marzo, Wendy Drewes, Elizabeth Rerisi, Reena Mathew, Haneen Aljayyousi, Sarwat I Chaudhry, Alexandra M Hajduk, Thomas M Gill, Deborah Estrin, Lara Kovell, Lee A Jennings, Samrachana Adhikari, John A Dodson, Antoinette Schoenthaler, Greg Sweeney, Ana Fonceva, Alicia Pierre, Jonathan Whiteson, Barbara George, Kevin Marzo, Wendy Drewes, Elizabeth Rerisi, Reena Mathew, Haneen Aljayyousi, Sarwat I Chaudhry, Alexandra M Hajduk, Thomas M Gill, Deborah Estrin, Lara Kovell, Lee A Jennings, Samrachana Adhikari

Abstract

Background: Participation in ambulatory cardiac rehabilitation remains low, especially among older adults. Although mobile health cardiac rehabilitation (mHealth-CR) provides a novel opportunity to deliver care, age-specific impairments may limit older adults' uptake, and efficacy data are currently lacking.

Objective: This study aims to describe the design of the rehabilitation using mobile health for older adults with ischemic heart disease in the home setting (RESILIENT) trial.

Methods: RESILIENT is a multicenter randomized clinical trial that is enrolling patients aged ≥65 years with ischemic heart disease in a 3:1 ratio to either an intervention (mHealth-CR) or control (usual care) arm, with a target sample size of 400 participants. mHealth-CR consists of a commercially available mobile health software platform coupled with weekly exercise therapist sessions to review progress and set new activity goals. The primary outcome is a 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 the characteristics that determine different patterns of use (eg, persistent high engagement and declining engagement).

Results: As of December 2021, the RESILIENT trial had enrolled 116 participants. Enrollment is projected to continue until October 2023. The 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 and characteristics that determine the sustained use of mHealth-CR. These findings will help design future precision medicine approaches to mobile health implementation in older adults. This knowledge is especially important in light of the COVID-19 pandemic that has shifted much of health care to a remote, internet-based setting.

Trial registration: ClinicalTrials.gov NCT03978130; https://ichgcp.net/clinical-trials-registry/NCT03978130.

International registered report identifier (irrid): DERR1-10.2196/32163.

Keywords: ambulatory care; cardiac rehabilitation; cardiology; clinical trial; health outcomes; heart disease; mHealth; mobile health; older adults; rehabilitation.

Conflict of interest statement

Conflicts of Interest: None declared.

©John A Dodson, Antoinette Schoenthaler, Greg Sweeney, Ana Fonceva, Alicia Pierre, Jonathan Whiteson, Barbara George, Kevin Marzo, Wendy Drewes, Elizabeth Rerisi, Reena Mathew, Haneen Aljayyousi, Sarwat I Chaudhry, Alexandra M Hajduk, Thomas M Gill, Deborah Estrin, Lara Kovell, Lee A Jennings, Samrachana Adhikari. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.03.2022.

Figures

Figure 1
Figure 1
Rehabilitation using mobile health for older adults with ischemic heart disease in the home setting (RESILIENT) study design overview. Participants will be randomized in a 3:1 manner to receive mobile health cardiac rehabilitation (mHealth-CR) versus usual care. A target of 400 participants will be enrolled to retain 320 with evaluable end points (accounting for 20% attrition between baseline and 3 months). AMI: acute myocardial infarction; CABG: coronary artery bypass graft; PCI: percutaneous coronary intervention.
Figure 2
Figure 2
Study intervention. The intervention includes commercially available mobile health cardiac rehabilitation software from Moving Analytics where participants record their physical activity and self-rate difficulty of their exercise session. This is coupled with passive activity monitoring and weekly phone calls with an exercise therapist for a duration of 3 months.

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