A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis.
BACKGROUND
Most patients who have had a stroke are dependent on informal caregivers for activities of daily living. The TRACS trial investigated a training programme for caregivers (the London Stroke Carers Training Course, LSCTC) on physical and psychological outcomes, including cost-effectiveness, for patients and caregivers after a disabling stroke.


METHODS
We undertook a pragmatic, multicentre, cluster randomised controlled trial with a parallel cost-effectiveness analysis. Stroke units were eligible if four of five criteria used to define a stroke unit were met, a substantial number of patients on the unit had a diagnosis of stroke, staff were able to deliver the LSCTC, and most patients were discharged to a permanent place of residence. Stroke units were randomly assigned to either LSCTC or usual care (control group), stratified by geographical region and quality of care, and using blocks of size 2. Patients with a diagnosis of stroke, likely to return home with residual disability and with a caregiver providing support were eligible. The primary outcome for patients was self-reported extended activities of daily living at 6 months, measured with the Nottingham Extended Activities of Daily Living (NEADL) scale. The primary outcome for caregivers was self-reported burden at 6 months, measured with the caregivers burden scale (CBS). We combined patient and caregiver costs with primary outcomes and quality-adjusted life-years (QALYs) to assess cost-effectiveness. This trial is registered with controlled-trials.com, number ISRCTN 49208824.


RESULTS
We assessed 49 stroke units for eligibility, of which 36 were randomly assigned to either the intervention group or the control group. Between Feb 27, 2008, and Feb 9, 2010, 928 patient and caregiver dyads were registered, of which 450 were in the intervention group, and 478 in the control group. Patients' self-reported extended activities of daily living did not differ between groups at 6 months (adjusted mean NEADL score 27·4 in the intervention group versus 27·6 in the control group, difference -0·2 points [95% CI -3·0 to 2·5], p value=0·866, ICC=0·027). The caregiver burden scale did not differ between groups either (adjusted mean CBS 45·5 in the intervention group versus 45·0 in the control group, difference 0·5 points [95% CI -1·7 to 2·7], p value=0·660, ICC=0·013). Patient and caregiver costs were similar in both groups (length of the initial stroke admission and associated costs were £13,127 for the intervention group and £12,471 for the control group; adjusted mean difference £1243 [95% CI -1533 to 4019]; p value=0·380). Probabilities of cost-effectiveness based on QALYs were low.


CONCLUSIONS
In a large scale, robust evaluation, results from this study have shown no differences between the LSCTC and usual care on any of the assessed outcomes. The immediate period after stroke might not be the ideal time to deliver structured caregiver training.


BACKGROUND
Medical Research Council.
Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK. Electronic address: a.forster@leeds.ac.uk.
Anne
A
Forster
Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.
Josie
J
Dickerson
Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust and University of Leeds, Bradford, UK.
John
J
Young
Institute of Psychiatry, King's College London, London, UK.
Anita
A
Patel
Department of Stroke Medicine, King's College London, London, UK.
Lalit
L
Kalra
Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Jane
J
Nixon
Department of Stroke Medicine, King's College London, London, UK.
David
D
Smithard
Institute of Psychiatry, King's College London, London, UK; Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
Martin
M
Knapp
Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Ivana
I
Holloway
Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Shamaila
S
Anwar
Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Amanda
A
Farrin
D000368:Aged; D017028:Caregivers / Q000191:economics / Q000193:education*; D016000:Cluster Analysis; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D019057:Quality-Adjusted Life Years; D020521:Stroke / Q000191:economics; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome