Background

Stroke is the commonest cause of severe disability in the community. Many survivors will 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 and friends who become caregivers. This caring role can have an effect on caregivers’ well-being with nearly half of caregivers reporting health problems, two-thirds a decline in social life and up to half of carers feel a burden of this role.

Aims & Objectives

The aim of the TRACS trial is to evaluate the clinical and cost effectiveness of a structured competency based caregiver-training programme for caregivers of stroke patients returning home with stroke-related disabilities.

The primary patient objective of the trial is to determine whether the training programme improves physical outcomes for patients after disabling stroke. The primary caregiver objective of the trial is to determine whether the training programme reduces the burden for caregivers of patients after disabling stroke.

Methods

TRACS has been designed as a pragmatic, multicentre, cluster randomised controlled trial with blinded follow-up. The unit of randomisation were the participating stroke rehabilitation units. 18 stroke units were randomised to deliver the intervention which includes a number of carer training sessions, competency assessment and one follow-up visit; and 18 stroke units were randomised to continue to deliver usual care as per the National Guidelines for Stroke.

Findings and Impacts

In total, 928 patients and caregivers were recruited to the trial (450 intervention group, 478 control group) . The results of the trial found no differences in patients’ functional independence, or caregivers’ burden between the intervention and control groups. No differences were found in patients and caregivers physical and psychological outcomes. Patients and caregivers in both groups had a similar length of hospital stay, and similar total health and social care and societal costs. Compliance with the intervention varied across stroke units but analysis demonstrated no link between the degree of compliance and associated patient or caregiver outcomes, indicating a dose effect is unlikely.

The TRACS trial is one the world’s largest completed stroke rehabilitation trials. The intervention evaluated had reported benefits in a previous single centre evaluation but these benefits have not been replicated in this large, multi-centre trial. The LSCTC provided a structured framework for caregiver training. It is possible that the immediate post-stroke period, when potential caregivers are coming to terms with their new situation, may not be the ideal time for the delivery of structured training. The intervention approach might be more relevant if delivered after discharge by community based teams.

Outputs

Forster A, Dickerson J, Young J, Patel A, Kalra L, Nixon J, Smithard D, Knapp M, Holloway I, Anwar S, Farrin A. A cluster randomised controlled trial and cost-effectiveness analysis of a structured training programme for caregivers of in-patients after stroke (TRACS). Cerebrovascular Diseases 2013;35:193. https://doi.org/10.3310/hta17460

Forster A, Dickerson J, Young J, Patel A, Kalra L, Nixon J, Smithard D, Knapp M, Holloway I, Anwar S, Farrin A. A Structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis. The Lancet 2013;382(9910):2069-2076. https://doi.org/10.1016/s0140-6736(13)61603-7

Forster A, Young J, Nixon J, Kalra L, Smithard D, Patel A, Knapp M, Monaghan J, Breen R, Anwar S. Farrin A. A cluster randomized controlled trial of a structured training programme for caregivers of inpatients after stroke (TRACS). International Journal of Stroke 2012;7(5): 94–99. https://doi.org/10.1111/j.1747-4949.2011.00722.x

Partners & Collaborators

Investigators
Forster A, Young J, Farrin A, Kalra L, Knapp M, Nixon J, Patel A, Smithard D

Timescales

03/07/2007 – 31/08/2011

Funding agency

Medical Research Council

Further information

For further information contact Anne Forster