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

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.