The Families In Recovery From Stroke Trial (FIRST): Primary Study Results

Objective: Social support and family ties are strong predictors of functional recovery after stroke; however, development of successful psychosocial intervention programs has been difficult. This study examined whether a family-systems intervention designed to influence social support and self-efficacy affects functional outcome in older stroke patients. Methods: Two hundred ninety-one community-residing survivors of ischemic stroke or nontraumatic cerebral hemorrhage from eight acute-care hospitals and rehabilitation centers were randomized to either psychosocial intervention (PSI) or usual care (UC). PSI involved up to 16 sessions conducted in the home by a mental health worker. Functional recovery (measured by the Barthel Index [BI] at 6 months postrandomization, inability to assess functioning because of illness or death) was the primary end point. Results: Functional recovery did not differ between UC and PSI in intention-to-treat analyses. In adjusted logistic regression, the odds of being functionally independent at 6 months was 60% higher in the intervention group, but this difference was not statistically significant (p = .31). Subgroup analyses revealed that PSI may be more effective in subjects with better psychologic and cognitive functioning and who required less inpatient rehabilitation. Conclusion: This study does not provide evidence for the efficacy of psychosocial intervention to improve functional recovery in stroke. Although PSI showed greater improvement than UC, the differences were not statistically significant. BASRS = Boston Aphasia Severity Rating Scale; BI = Barthel Index; CES-D = Center for Epidemiologic Studies Depression Scale; FIRST = Families in Recovery from Stroke Trial; MMSE = Mini-Mental Status Exam; NIH = National Institutes of Health; NIHSSI = National Institutes of Health Stroke Severity Index; PSI = psychosocial intervention; REFFI = recovery efficacy; RSS = received social support; SIS = Social Isolation Scale; TOAST = Trial of ORG 10172 in Acute Stroke Treatment; UC = usual care.