Title: Behavioural Intervention for Stroke Carers (BISC)
Funder: Department of Health and Social Care

Abstract: Carers of stroke patients play an important role in the rehabilitation process and long term management of the stroke survivor.4 However evidence suggests that carers are left feeling inadequately informed and ill-prepared and have difficulty adjusting to the consequences of the stroke.5 Carers are suffering too and are often left to cope alone. Carers adjustment to stroke has important implications on the quality of life of both the stroke survivor and carer. Therefore, early recognition and intervention in clinical practice may prevent or alleviate carers problems, and may help stroke survivors living in the community to remain at home as long as possible avoiding institutionalisation and premature residential placement. Currently, there is little in the way of emotional support for carers in the community, and area has been identified by the stroke clinical and research community and the Stroke Association as a priority area for further enquiry. Stroke rehabilitation is about helping survivors and their families return to a normal life, and facilitating them to lead the lives they wish. Both cognitive and behavioural mechanisms play a role in psychological adjustment to chronic health related illnesses and the aim of this project would enable the development and evaluation of the evidence based Cognitive Behavioural Therapy (CBT) intervention for improving adjustment and mood in carers of stroke patients. However there has been no research to date addressing the effectiveness of CBT for carers of stroke patients. The purpose of the feasibility trial is to explore whether CBT for carers of stroke patients is both feasible and well tolerated. We wish to work closely with carers of stroke patients to tailor treatment to their unique needs and difficulties. We wish to estimate important parameters prior to conducting a large definitive trial to test whether this new intervention will improve outcomes for carers of stroke patients with mood and adjustment difficulties. The findings will inform future work in conducting a large definitive trial of the effectiveness of the intervention. Focus groups with carers of stroke patients will be used to determine and inform the precise content of the CBT intervention. A nominal group technique with expert panellists will be facilitated to gain consensus on the final content of the intervention. Carers will be identified and invited to take part in the study when the person they are caring for is discharged from Nottinghamshire Hospitals. Participants who meet the eligibility criteria will be randomised to either the CBT intervention group or usual care. We aim to recruit a total of 40 carers. Health-related outcome measures will be completed with both patients and their carers at baseline, 2 and 4 months post randomisation. The intervention will last for 6 weeks. Feedback interviews will be completed with carers to gain greater insight and understanding of the acceptability of the intervention. The project has the potential to improve the quality of life of those caring for a stroke patient and our close partnerships with commissioners and healthcare providers would assist in translating our research findings into clinical practice. CBT has been found to be a cost-effective intervention in other conditions and this trial would add great value in commissioning an effective intervention as part of stroke rehabilitation. The minimisation and reduction of financial expenditure is of particular importance in the current environment given the reduction in health care budgets. If in the health economic evaluation of the larger definitive trial, we were to find that CBT improves health related outcomes and the quality of life of both the stroke patient and carer, there would be potential widespread costs savings within the NHS and social care.

Lay abstract: The advances in stroke rehabilitation mean that more patients than ever are now residing in the community with informal support from their spouse or other informal carer. The transition from hospital to home setting can be perceived as both demanding and complex, which can have an adverse impact on the health and quality of life of both the stroke patient and carer. There is little in the way of emotional support for carers in the community. Currently services do not focus on providing support to carers to adjust to the caregiving role and its demands. Our aim is to develop, tailor and target the delivery of a behavioural intervention that satisfies the unique needs and difficulties experienced by carers of stroke patients. We will first develop the intervention program by conducting focus groups with carers of stroke patients and then finalise the precise content of the intervention with expert panellists within this field. The main purpose of the intervention is to improve the adjustment and mood of carers. Ultimately we would like to know if the intervention improves the long term outcome of carers of stroke patients and survivors themselves. However first, we must make sure that we can identify suitable people who would benefit from the intervention, and that people are willing to complete all sessions provided. Participants will be identified and screened for eligibility on hospital discharge. We will collect descriptive and clinical data on each consenting participant such as age, home circumstances, employment status, current mood etc. We will randomly allocate carers to either receive the behavioural intervention for a period of 6 weeks or to a control group who will receive usual care. Following the intervention period, we will collect data from both groups which we will then analyse to inform a future definitive trial.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: STROKE