A cluster randomised controlled trial of a structured training programme for caregivers of in-patients after stroke
Lead Research Organisation:
University of Leeds
Department Name: Healthcare Studies, School of
Abstract
We aim to test whether a training programme provided to carers of stroke patients can reduce the burden on caregivers and improve stroke patients’ rehabilitation. Following a stroke, many patients are disabled and require help with activities of daily living, such as moving, bathing, dressing, and toileting. After discharge from hospital, this help is often provided by family members. The sudden change in lifestyle is very difficult and it can be hard for stroke patients and their families to cope. Many patients become depressed and are reluctant to go out and caregivers become stressed and anxious. This study aims to see if a hands on structured training programme for carers can reduce this burden and also improve patient’s physical ability. The study involves 36 hospital stroke units from different areas of the country. In half of these stroke units, caregivers will be trained using the hands on skilled training programme. We will compare patients and caregivers that have received the training with those who have not. We will look at their mental health, social life, physical progress and value for money. If the study shows that patients and caregivers do better with the training, we will be able to suggest that such a training programme be provided to all patients and their caregivers after stroke
Technical Summary
Background: Stroke remains a major health problem in the 21st Century with considerable personal, financial and societal burdens. It is the major cause of serious disability in the community and the cost of stroke to the NHS is estimated to be over #2.5 billion annually. After the recommended initial hospital admission, up to 74% of stroke survivors require help with activities of daily living from informal caregivers, often family members. These caregivers are often ill-prepared for the physical and psychological requirements of caring for someone after stroke. In a recent single centre, randomised controlled trial, Kalra et al., (British Medical Journal,2004;328:1099-1104) have reported the effectiveness of a structured ?hands on? training programme for caregivers which assessed competencies in skills essential for the day to day management of disabled stroke survivors. There are limitations to the generalisability of a single centre trial findings. We wish to test the effectiveness of the structured training programme on improving patient outcomes and investigate its wider generalisability in settings where the population, health and social care provision vary.
Methods: A pragmatic, cluster randomised, controlled trial with blinded follow-up is planned. Thirty participating stroke units will be stratified prior to randomisation by geographical location and a quality of care indicator. Members of the multidisciplinary teams in the units randomised to the intervention group will be trained to deliver the structured competency-based training programme to caregivers as an integral part of the ward care process. Outcomes will be measured by postal questionnaire at six months after recruitment, with final follow-up at twelve months. The primary outcome is the extended activities of daily living for the patient (Nottingham Extended ADL Scale), secondary outcomes include patient mood, functional ability and quality of life and for the caregiver compliance with the intervention and burden. A sample size of 900 patients will provide 80% power at 5% significance level to detect a clinically relevant difference of six points in the primary outcome measure and to detect an effect size of one third in any of the secondary outcomes. The clinical outcome study will be complemented by an embedded health economic evaluation.
Application: If a structured, competency-based programme of caregiver training is confirmed as effective in a larger study, this would provide a clear direction for clinical practice development in stroke units with a shift from the current predominantly patient-centred processes to a greater routine emphasis on combined patient and carer-centred strategies.
Methods: A pragmatic, cluster randomised, controlled trial with blinded follow-up is planned. Thirty participating stroke units will be stratified prior to randomisation by geographical location and a quality of care indicator. Members of the multidisciplinary teams in the units randomised to the intervention group will be trained to deliver the structured competency-based training programme to caregivers as an integral part of the ward care process. Outcomes will be measured by postal questionnaire at six months after recruitment, with final follow-up at twelve months. The primary outcome is the extended activities of daily living for the patient (Nottingham Extended ADL Scale), secondary outcomes include patient mood, functional ability and quality of life and for the caregiver compliance with the intervention and burden. A sample size of 900 patients will provide 80% power at 5% significance level to detect a clinically relevant difference of six points in the primary outcome measure and to detect an effect size of one third in any of the secondary outcomes. The clinical outcome study will be complemented by an embedded health economic evaluation.
Application: If a structured, competency-based programme of caregiver training is confirmed as effective in a larger study, this would provide a clear direction for clinical practice development in stroke units with a shift from the current predominantly patient-centred processes to a greater routine emphasis on combined patient and carer-centred strategies.
