A feasibility and pilot randomized controlled trial of the “Timing it Right Stroke Family Support Program”

Abstract

Objective:

Examine feasibility of conducting a randomized controlled trial of the Timing it Right Stroke Family Support Program (TIRSFSP) and collect pilot data.

Design:

Multi-site mixed method randomized controlled trial.

Setting:

Acute and community care in three Canadian cities.

Subjects:

Caregivers were family members or friends providing care to individuals who experienced their first stroke.

Intervention:

The TIRSFSP offered in two formats, self-directed by the caregiver or stroke support person-directed over time, were compared to standard care.

Main measures:

Caregivers completed baseline and follow-up measures 1, 3 and 6 months post-stroke including Centre for Epidemiological Studies Depression, Positive Affect, Social Support, and Mastery Scales. We completed in-depth qualitative interviews with caregivers and maintained intervention records describing support provided to each caregiver.

Results:

Thirty-one caregivers received standard care (n=10), self-directed (n=10), or stroke support person-directed (n=11) interventions. We retained 77% of the sample through 6-months. Key areas of support derived from intervention records (n=11) related to caregiver wellbeing, caregiving strategies, patient wellbeing, community re-integration, and service delivery. Compared to standard care, caregivers receiving the stroke support person-directed intervention reported improvements in perceived support (estimate 3.1, P=.04) and mastery (estimate .35, P=.06). Qualitative caregiver interviews (n=19) reflected the complex interaction between caregiver needs, preferences and available options when reporting on level of satisfaction.

Conclusions:

Preliminary findings suggest the research design is feasible, caregivers’ needs are complex, and the support intervention may enhance caregivers’ perceived support and mastery. The intervention will be tested further in a large scale trial.