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.

Publications

10 25 50
 
Description Citated as an example of increasing clinical engagement in research by the DH Stroke Improvement Programme
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Citation in RCP National Clinical Guideline for stroke 2016
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical reviews
URL https://www.strokeaudit.org/SupportFiles/Documents/Guidelines/2016-National-Clinical-Guideline-for-S...
 
Description NHMRC
Amount $1,533,894 (AUD)
Funding ID APP1045391 
Organisation National Health and Medical Research Council 
Sector Public
Country Australia
Start 09/2012 
End 10/2016
 
Description NIHR Research for Patient Benefit (Process evaluation embedded within a randomised trial of caregiver training after stroke)
Amount £249,633 (GBP)
Funding ID PB-PG-0407-13308 
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start 09/2008 
End 06/2011
 
Title Member of International round table consensus conference relating to stroke recovery and rehabilitation 
Description Consensus agreement on methods used 
Type Of Material Improvements to research infrastructure 
Year Produced 2017 
Provided To Others? Yes  
Impact Consensus recommendations published 
 
Description Clinical Trials Research Unit University of Leeds 
Organisation University of Leeds
Department Leeds Clinical Trials Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution Joint working on trial development and implementation. Creating two of the worlds largest stroke rehabilitation trials.
Collaborator Contribution Methodological expertise
Impact Joint publications, successful NIHR programme grant application
 
Description KIngs College London 
Organisation King's College London
Department Department of Primary Care & Public Health Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Joint working on research grants. successful application for NIHR Programme Grant.
Collaborator Contribution Expertise in qualitative methods
Impact Successful application for a NIHR Programme Grant
Start Year 2009
 
Title Family-led Rehabilitation after Stroke 
Description Following the completion of the An Intervention/training programme was developed Family-led Rehabilitation after Stroke 
Type Therapeutic Intervention - Physical
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2017
Development Status On hold
Clinical Trial? Yes
UKCRN/ISCTN Identifier ACTRN12613000078752 (Australia) and CTRI/2013/04/003557 (India)
Impact The intervention was design to enhance stroke care in Low and Middle Income Countries. Unfortunately the trial was negative, we are considering further refinements. 
 
Title The London Stroke Caregivers Training Course (LSCTC) 
Description The LSCTC is the intervention assessed in the TRACS trial. It consists of 14 training components, 6 mandatory, 8 dependent upon patient and carer needs. Training is followed by checking of carer competency. The TRACS trial demonstrated no clinical or statistical benefit of the LSCTC when provided as an in-patient intervention. It may have more benefit post-discharge. 
Type Therapeutic Intervention - Physical
Current Stage Of Development Initial development
Year Development Stage Completed 2012
Development Status On hold
Clinical Trial? Yes
Impact Assessed in 930 patient and caregiver dyads. Process evaluation study indicate it was acceptable for use by MDTs on Stroke Units but external factors led to complications in implementing this complex intervention in the in-patient setting. It may have more impact/benefit in the community. 
URL http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=2290
 
Description Consumer Group Yorkshire 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Workshop Facilitator
Geographic Reach Regional
Primary Audience Patients, carers and/or patient groups
Results and Impact Update on the resesarch provided to the Consumer Research Advisory group - approximately 15 attendees

Enhanced consumer engagement in the work of the research team.
Year(s) Of Engagement Activity 2007,2008,2009,2010,2011
 
Description European Stroke Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Health professionals
Results and Impact A Forster. Caregiver training after stroke. European Stroke Conference, 7th stroke meeting for nurses, physiotherapists, speech and occupational therapists and study/research assistants. May 2013, London.

Invitation to speak at the World Stroke Conference in Turkey in October 2014.

Liaison with colleagues in Canada undertaking similar work and application submitted for visiting fellowship.
Year(s) Of Engagement Activity 2013
 
Description Joining Forces South West Stroke Research Day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact Clinicians, researchers, stroke survivors and their carers attended an annual research event organised by the South West Stroke Research Network.

Informing those involved in the research with the study results - clinical staff completing the intervention, researchers completing the research and patient and caregivers who may have participated.
Year(s) Of Engagement Activity 2012
 
Description World Stroke Day event, North West NIHR Stroke Research Network 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Regional
Primary Audience Participants in your research and patient groups
Results and Impact Stroke survivor and carer event on world stroke day, organised by the North West Stroke Research Network, attended by 150 stroke survivors, carers and researchers.

Patient and carer informed of the results of the TRACS trial.
Year(s) Of Engagement Activity 2012