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Rehabilitation of patients after transient ischaemic attack or minor stroke: pilot feasibility randomised trial of a home-based prevention programme [with consumer summary]
Heron N, Kee F, Mant J, Cupples ME, Donnelly M
British Journal of General Practice 2019 Oct;69(687):E706-E714
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Although the importance of secondary prevention after transient ischaemic attack (TIA) or minor stroke is recognised, research is sparse regarding novel, effective ways in which to intervene in a primary care context. AIM: To pilot a randomised controlled trial (RCT) of a novel home-based prevention programme (The Healthy Brain Rehabilitation Manual) for patients with TIA or 'minor' stroke. DESIGN AND SETTING: Pilot RCT, home-based, undertaken in Northern Ireland between May 2017 and March 2018. METHOD: Patients within 4 weeks of a first TIA or 'minor' stroke received study information from clinicians in four hospitals. Participants were randomly allocated to one of three groups: standard care (control group) (n = 12); standard care with manual and GP follow-up (n = 14); or standard care with manual and stroke nurse follow-up (n = 14). Patients in all groups received telephone follow-up at 1, 4, and 9 weeks. Eligibility, recruitment, and retention were assessed; stroke/cardiovascular risk factors measured at baseline and 12 weeks; and participants' views were elicited about the study via focus groups. RESULTS: Over a 32-week period, 28.2% of clinic attendees (125/443) were eligible; 35.2% of whom (44/125) consented to research contact; 90.9% of these patients (40/44) participated, of whom 97.5% (39/40) completed the study. After 12 weeks, stroke risk factors (cardiovascular risk factors, including blood pressure and measures of physical activity) improved in both intervention groups. The research methods and the programme were acceptable to patients and health professionals, who commented that the programme 'filled a gap' in current post-TIA management. CONCLUSION: Findings indicate that implementation of this novel cardiac rehabilitation programme, and of a trial to evaluate its effectiveness, is feasible, with potential for clinically important benefits and improved secondary prevention after TIA or 'minor' stroke.

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