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Updated: Apr 7, 2026
Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
Published on: June 6, 2025
Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care
Anne Forster1, John Young2, Katie Chapman2
1From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.). a.forster@leeds.ac.uk.
Background And Purpose:
We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke.
Methods:
A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months.
Results:
Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups.
Conclusions:
This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice.
Clinical Trial Registration:
URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305.
