Frailty modifies effectiveness of psychosocial intervention in recovery from stroke

Objective: To evaluate the impact of a psychosocial intervention on instrumental activities of daily living, physical performance, cognition and mortality after stroke. Design: A randomized clinical trial. Setting: Patients were recruited from hospitals and rehabilitation centres; the intervention took place in subjects' homes. Subjects: Two-hundred and ninety-one stroke survivors over age 45. One-hundred and forty-six subjects were assigned to the intervention and 145 subjects were assigned to usual care. Intervention: Up to 16 meetings conducted over six months in the patient's home (approximately weekly for 12 weeks, followed by tri-weekly sessions for another 12 weeks). Sessions lasted approximately 1 hour and included, when possible, the entire support system (stroke survivor, primary caregiver, additional family and friends, and professional caregivers). Main outcome measures: Instrumental activities of daily living, physical performance, and cognition were assessed six months post stroke; mortality was assessed at an average of 47 months post stroke. Results: No significant differences in outcomes were observed between the intervention and usual care groups when analysing the total study population. Among non-frail participants (n = 156), subjects randomized to treatment had better scores on instrumental activities of daily living (mean score among treated = 12.4 (standard deviation (SD) = 2.1), mean score among usual care subjects = 11.3 (SD = 2.9), P-value for difference in means = 0.01) and reduced risk of mortality (P = 0.03) than subjects randomized to usual care. Conclusion: While there is evidence that the treatment benefited healthier subgroups, results also show evidence that the treatment was not effective, and possibly harmful, in frail subgroups.