Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anne Forster
ORCID ID
Contact details
Academic Unit of Elderly Care and Rehabilitation
Temple Bank House
Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 383 406/401
a.forster@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
470772, G0501807
Study information
Scientific title
Training Caregivers after Stroke (TRACS): a cluster randomised controlled trial of a structured training programme for caregivers of in-patients after stroke
Acronym
TRACS
Study hypothesis
The hypothesis for TRACS, based on results from a previous single centre study, is that a competency based caregiver-training programme (The London Stroke Carer Training Course, LSCTC) should improve patient outcomes in patients with disabling stroke. The study aims to evaluate the clinical and cost effectiveness of the training programme (LSCTC) by embedding it in usual practise to test the wider generalisability in settings where the population, health and social care provision differ.
Please note that as of 19/03/2008 this record was extensively updated. All changes are shown under the relevant fields with the date of change noted as 19/03/2008. Please also note that the anticipated start and end dates of this trial have been updated to the dates mentioned below. The previous trial dates were as follows:
Previous anticipated start date: 01/04/2007
Previous anticipated end date: 31/10/2010
Please note that as of 08/02/10 this trial has been extended from 31/10/10 to 31/08/11
Ethics approval
Favourable ethical opinion received from the Leeds (West) Research Ethics Committee on 2nd February 2007. Ref: 07/Q1205/12
Study design
Pragmatic multicentre cluster randomised controlled trial with blinded follow-up
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Disabling Stroke
Intervention
Current interventions as of 19/03/2008:
This is a cluster, randomised, controlled trial and aims to recruit 900 patients and caregivers in 36 stroke rehabilitation units. The intervention developed by Kalra and colleagues is known as the London Stroke Carer Training Course (LSCTC) and comprises a number of carer training sessions, competency assessment and one follow up session after discharge. The multidisciplinary teams (MDTs) in the units randomised to the intervention group will be trained to deliver the LSCTC, whilst those randomised to the control group will continue to provide usual care as per the National Guidelines.
Stroke rehabilitation units randomised to the control group will continue to provide usual care as per the National Guidelines for Stroke.
Previous interventions:
Stroke units will be randomised into intervention or control groups using the stratification factors of geographical site and quality of care.
Caregivers of inpatients in stroke rehabilitation units randomised to the intervention group will receive the London Stroke Carer Training Course (LSCTC) programme. Caregivers will receive 3-5 caregiver training sessions (depending on need) lasting 30-45 minutes, competency assessment and one home visit. Multidisciplinary teams in these stroke units will be trained to deliver the intervention.
Stroke rehabilitation units randomised to the control group will continue to provide usual care as per the National Guidelines for Stroke.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Current primary outcome measure(s) as of 19/03/2008:
Patient: Nottingham Extended Activities of Daily Living (NEADL)
Caregiver: Caregivers Burden Scale
Primary outcomes are measured at six months after recruitment.
Previous primary outcome measure(s):
The primary outcome is Nottingham Extended Activities of Daily Living (NEADL) for patients at 6 months after recruitment.
Secondary outcome measures
Current secondary outcome measure(s) as of 19/03/2008:
Patient:
1. Hospital Anxiety and Depression Scale (HADS) (mood)
2. Euro-quality of life (EQ-5D) (health state)
3. Barthel Index (activities of daily living)
4. Death
5. Institutionalisation
6. Re-admission
7. Stroke Impact Scale (functional ability and health related quality of life)
8. Costs based on Client Service Receipt Inventory
Caregiver:
1. Compliance with intervention
2. Frenchay activities index (social restriction)
3. HADS
4. EQ-5D
5. Death
6. Hospitalisation
7. Institutionalisation
8. Costs based on Client Service Receipt Inventory
Secondary outcomes measured at the final follow up at 12 months.
Previous secondary outcome measure(s):
The secondary outcome measures for patients at 6 months and 12 months are:
1. Hospital Anxiety and Depression Scale (HADS) (mood)
2. EQ - 5D (health state)
3. Barthel Index (activities of daily living)
4. Stroke Impact Scale (functional ability and health related quality of life)
5. Costs based on the Client Service Receipt Inventory (CSRI)
6. Death
7. Institutionalisation
8. Re−admission
The Nottingham Extended Activities of Daily Living (NEADL) at 12 months is also a patient secondary outcome measure to assess whether any intervention effect is sustained.
The secondary outcome measures for caregivers at 6 and 12 months are:
1. Compliance with the intervention (LSCTC, measured by number of training sessions, time taken, competencies signed off)
2. Caregivers Burden Scale
3. Frenchay activities index (social restriction)
4. HADS (mood)
5. EQ−5D (health state)
6. Death
7. Hospitalisation
8. Institutionalisation
Overall trial start date
18/02/2008
Overall trial end date
31/08/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 19/03/2008:
Stroke Rehabilitation Units:
A stroke rehabilitation unit will be defined according to the definition provided by the Royal College of Physicians of London for the National Sentinel Stroke Audit 2004 by the presence of 4/5 of the following criteria:
1. Consultant physician with responsibility for stroke
2. Formal links with patient and caregiver organisations
3. Multidisciplinary meetings at least weekly to plan patient care
4. Provision of information to patients about stroke
5. Continuing education programmes for staff
Patient:
1. Patient has a confirmed primary diagnosis of new stroke
2. Is medically stable
3. Is likely to return home but with residual disability
4. Have a caregiver available, defined as the main person, other than health, social or voluntary care provider, helping with activities of daily living and/or advocating on behalf of the patient
5. Written informed consent/caregiver assent and caregiver consent will be obtained prior to any trial specific procedures
Caregiver:
1. Caregiver is willing and able to provide support after discharge
2. Fulfils the trial definition of a caregiver
Previous inclusion criteria:
Stroke Rehabilitation Units:
A stroke rehabilitation unit will be defined according to the definition provided by the Royal College of Physicians of London for the National Sentinel Stroke Audit 2004 by the presence of 4/5 of the following criteria:
1. Consultant physician with responsibility for stroke
2. Formal links with patient and caregiver organisations
3. Multidisciplinary meetings at least weekly to plan patient care
4. Provision of information to patients about stroke
5. Continuing education programmes for staff
An additional criterion will be that the majority of patients on the unit will have a diagnosis of stroke.
Patients with the following characteristics are eligible for this trial:
1. Have a confirmed primary diagnosis of new stroke
2. Are medically stable (defined as sitting out of bed for at least four hours per day)
3. Are likely to return home but with residual disability (defined as a modified Rankin score of >=3)
4. Have a caregiver available, defined as the main person, other than health, social, or voluntary care provider, helping with activities of daily living and advocating on behalf of the patient, who has no notable disability (defined as a modified Rankin score of 0-2) and who is willing and able to provide support after discharge
5. Written informed patient consent/relative assent and caregiver consent will be obtained prior to any trial specific procedures
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
900 patients and caregivers
Participant exclusion criteria
Current exclusion criteria as of 19/03/2008:
1. If discharge is planned within one week of admission to the stroke rehabilitation unit (insufficient time to instigate the intervention)
2. If the patient is in need of palliative care
3. If the patient or caregiver were registered to the trial on a previous admission
Previous exclusion criteria:
1. If discharge is planned within 96 hours of admission to the stroke rehabilitation unit (insufficient time to instigate the LSCTC)
2. If the patient has a concurrent illness requiring, or likely to require, palliative care
3. If the patient or caregiver was registered to the trial on a previous admission
Recruitment start date
18/02/2008
Recruitment end date
31/08/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit of Elderly Care and Rehabilitation
Bradford
BD9 6RJ
United Kingdom
Funders
Funder type
Government
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24054816
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24153026
Publication citations
-
Results
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., Lancet, 2013, 382, 9910, 2069-2076, doi: 10.1016/S0140-6736(13)61603-7.
-
Results
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 economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial., Health Technol Assess, 2013, 17, 46, 1-216, doi: 10.3310/hta17460.