JMIR Publications

ABSTRACT

Background:

Stroke is a leading cause of serious, long-term disability, and has a sudden onset. Upon discharge to the home setting, families are thrust into providing care, often without sufficient training from health care providers. Caregiving without proper training can be detrimental to a caregiver’s physical and mental health, which can impede survivor rehabilitation and lead to institutionalization and higher societal costs. Aligned with current patient and caregiver guidelines, the Telehealth Assessment and Skill-Building Kit (TASK III) is a nurse-led intervention designed to empower caregivers to address their own and the survivor’s needs using innovative skill-building strategies.

Objective:

The purpose of this study is to test short-term (immediately post intervention at 8 weeks) and long-term (12, 24, and 52 weeks) efficacy of the TASK III intervention, compared with an Information, Support, and Referral (ISR) group to improve caregiver life changes as a result of providing care (i.e., physical health, physical functioning, emotional well-being, general health).

Methods:

A randomized controlled clinical trial design will be used with baseline data collection from 296 family caregivers by telephone after the stroke survivor is discharged home. Caregivers randomized to the ISR group (n=148) will receive information from the American Heart Association about stroke family caregiving. Caregivers randomized to TASK III group (n=148) will receive a TASK III Resource Guide and information from the American Heart Association. Both groups receive 8 weekly calls from a nurse, with a booster call a month later. Outcomes are assessed by blinded data collectors at 8, 12, 24, and 52 weeks. The primary outcome (at 8 weeks) is caregiver life changes. Secondary outcomes are depressive symptoms, other symptoms (stress, fatigue, sleep, pain, shortness of breath), unhealthy days, diet, exercise, and self-reported healthcare utilization. Mediators are task difficulty, threat appraisal, and self-efficacy. Program evaluation outcomes (satisfaction, technology ratings) will also be analysed.

Results:

Enrollment and randomization of the first participant was on November 30, 2022, with an anticipated completion of recruitment being November 30, 2025. Completion of the primary endpoint data analysis is anticipated to be August 31, 2026, with reporting of results in Clinicaltrials.gov anticipated to be by April 01, 2027. As of October 9, 2024, a total of 198 family caregivers (66.9% of the proposed total sample of N=296) have been enrolled and randomized to the TASK III group (n=98) or to the ISR group (n=100).

Conclusions:

If TASK III is shown to be efficacious in the proposed randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care; and, to adapt it for use among caregivers with other debilitating/chronic conditions providing a tremendous public health impact. Clinical Trial: Clinicaltrials.gov ID: NCT05304078. Registered on March 10, 2022. Last update performed on January 25, 2024. Located at https://clinicaltrials.gov/study/NCT05304078.