Objective: To examine the effect of contact with a stroke family care worker on the physical, social, and psychological status of stroke patients and their carers. Design: Randomised controlled trial with broad entry criteria and blinded outcome assessment six months after randomisation. Setting: A well organised stroke service in an Edinburgh teaching hospital Subjects: 417 patients with an acute stroke in the previous 30 days randomly allocated to be contacted by a stroke family care worker (210) or to receive standard care (207). The patients represented 67% of all stroke patients assessed at the hospital during the study period. Main outcome measures: Patient completed Barthel index, Frenchay activities index, general health questionnaire, hospital anxiety and depression scale, social adjustment scale, mental adjustment to stroke scale, and patient satisfaction questionnaire; carer completed Frenchay activities index, general health questionnaire, hospital anxiety and depression scale, social adjustment scale, caregiving hassles scale, and carer satisfaction questionnaire. Results: The groups were balanced for all important baseline variables. There were no significant differences in physical outcomes in patients or carers, though patients in the treatment group were possibly more helpless, less well adjusted socially, and more depressed, whereas carers in the treatment group were possibly less hassled and anxious. However, both patients and carers in the group contacted by the stroke family care worker expressed significantly greater satisfaction with certain aspects of their care, in particular those related to communication and support. Conclusions: The introduction of a stroke family care worker improved patients' and their carers' satisfaction with services and may have had some effect on psychological and social outcomes but did not improve measures of patients' physical wellbeing. A stroke family care worker in the context of a well organised hospital based stroke service has no definite beneficial effect on the physical, social, or psychological outcome of patients or their carers A stroke family care worker may reduce carers' hassles and anxiety but render patients more helpless, less well socially adjusted, and more depressed A stroke family care worker may improve patients' and their carers' satisfaction with those aspects of stroke services relating to communication and support Purchasers of health care need to decide the value they and their patients place on satisfaction with health care