Contemp Clin Trials Commun. 2026 Jan 20;49:101604. doi: 10.1016/j.conctc.2026.101604. eCollection 2026 Feb.
ABSTRACT
BACKGROUND: Older adult family caregivers of persons with heart failure experience substantial burden due to the complex care needs of their care recipients. Targeted interventions for this population remain limited. To address this gap, we developed a digital health physical activity coaching intervention specifically designed for older family caregivers of persons with heart failure. In this paper, we describe the protocol for a pilot randomized controlled trial evaluating the preliminary feasibility and effects of the intervention in improving physical and mental health as well as caregiving self-efficacy and quality of life.
METHODS: The study aims to test a 12-week, two-arm pilot randomized controlled trial of older caregivers of persons with heart failure. Study enrollment began in June 2024. Participants are enrolled from inpatient units and outpatient clinics at a large medical center in the U.S. and randomized to the intervention or control arm. Participants in the intervention arm receive 24 exercise coaching sessions and motivational text messages over 12 weeks. Both groups are provided with Fitbit devices to monitor physical activity. Data are collected at baseline, during the intervention (1 and 2 months), on exit, and post-intervention (1 and 3 months following completion). Participants in the control arm receive a 1-page handout with general information on caregiver self-care. The primary outcome is daily step counts as measured by the Fitbit device.
CONCLUSION: Findings from this pilot trial will inform a subsequent efficacy study of the digital health physical activity coaching intervention in a larger, more diverse population of older family caregivers of adults with heart failure.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05852509.
PMID:41631240 | PMC:PMC12860786 | DOI:10.1016/j.conctc.2026.101604