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Lifestyle counselling as secondary prevention in patients with minor stroke or transient ischemic attack: a randomized controlled pilot study [with consumer summary]
Liljehult J, Molsted S, Moller T, Overgaard D, Christensen T
Pilot and Feasibility Studies 2024 Mar 22;10(50):Epub
clinical trial
2/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Patients with minor stroke or transient ischemic attacks have an increased risk of future strokes. These patients are often discharged home with limited specialized follow-up, although close to half of them experience cognitive deficits. Simple encouragements to avoid smoking, be physically active, and to take preventive medication are often insufficient to ensure adherence and more comprehensive interventions are needed to support the patients in adapting healthy behaviour. The aim of this study was to test the feasibility and potential effect of an early initiated, patient-centred intervention to patients with minor stroke or transient ischemic attacks targeting smoking, physical activity, and medication adherence, in a randomized, controlled pilot trial. METHODS: Hospitalized patients were randomized to usual care or an intervention consisting of health behavioural counselling based on the 5A's model, telephone follow-up (4 and 8 weeks), and monitoring of physical activity. Follow-up time was 12 weeks. Feasibility was on the following domains: eligibility, acceptance, demand and practicality, adherence, attrition, and implementation and integration. RESULTS: Forty patients of 84 potentially eligible were randomized to the two treatment arms (20 intervention/20 usual care). Thirty-two completed the 12-week follow-up, while 8 were either excluded or lost to follow-up. With few changes, the intervention was feasible and possible to deliver according to the protocol. CONCLUSIONS: It was possible to identify relevant patients who could potentially benefit from a behavioural intervention, recruit and randomize them early after admission and retain most participants in the study until follow-up and derive statistical estimates to guide the design of large-scale randomized controlled trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03648957. Registered 28 August 2018.

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