当前位置: X-MOL 学术Pilot Feasibility Stud. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Lifestyle counselling as secondary prevention in patients with minor stroke and transient ischemic attack: study protocol for a randomized controlled pilot study
Pilot and Feasibility Studies Pub Date : 2020-03-25 , DOI: 10.1186/s40814-020-00583-4
Jacob Liljehult 1, 2, 3 , Stig Molsted 4 , Tom Møller 2, 5 , Dorthe Overgaard 3 , Lis Adamsen 2, 5 , Mary Jarden 5, 6 , Thomas Christensen 1, 6
Affiliation  

Most patients with minor stroke or transient ischemic attack (TIA) are discharged with little or no specialised follow-up. Nonetheless, these patients have a high prevalence of cognitive impairments and a considerable risk of recurrent stroke. Smoking cessation, physical activity, and adherence to antihypertensive and antithrombotic medication are highly recommended in patients with minor stroke and TIA. Evidence suggests that simple encouragement to change lifestyle is ineffective. Behavioural interventions might therefore be needed to support patients in managing their own health post-discharge. We aim to test the (1) feasibility of randomisation acceptance and an early initiated, client-centred lifestyle and behavioural intervention in a clinical setting, and (2) potential effect of the intervention on arterial blood pressure in patients with minor stroke or TIA and (3) explore the participants experience of barriers and facilitators for health behaviour after a stroke, including perceived needs and social support. We will conduct a randomized controlled pilot trial: Eligible patients with acute minor stroke or TIA (n = 40) will be randomly allocated to either early initiated counselling with four weekly post-discharge follow-up sessions for 12 weeks or usual care. The primary outcome will be program feasibility and to discuss the relevance of arterial blood pressure as primary outcome after 12 weeks intervention. Selected participants will be invited to participate in semi-structured interviews, based on purposeful sampling, to evaluate the intervention and explore their experience of life after a stroke. The interviews will be analysed using a five-step thematic analysis approach. The study will provide evidence of the feasibility and potential effect of early initiated counselling on cardiovascular risk factors in patients with minor stroke and TIA. Qualitative interviews will contribute with a more nuanced understanding of the barriers and facilitators of health enhancing behaviour. Optimizing health behaviour counselling and providing formal support to the patients’ post-discharge may ease the transition and help more patients adhere to lifestyle and medication recommendations. ClinicalTrial.gov, NCT03648957

中文翻译:

生活方式咨询作为轻度中风和短暂性脑缺血发作患者的二级预防:随机对照试验研究方案

大多数患有轻微中风或短暂性脑缺血发作 (TIA) 的患者在出院时很少或没有专门的随访。尽管如此,这些患者的认知障碍患病率很高,并且有相当大的卒中复发风险。强烈建议轻度卒中和 TIA 患者戒烟、进行体育锻炼并坚持服用抗高血压和抗血栓药物。有证据表明,简单的鼓励改变生活方式是无效的。因此,可能需要行为干预来支持患者在出院后管理自己的健康。我们的目标是在临床环境中测试 (1) 随机化接受和早期启动、以客户为中心的生活方式和行为干预的可行性,(2) 干预对轻度卒中或 TIA 患者动脉血压的潜在影响和 (3) 探讨参与者对卒中后健康行为的障碍和促进因素的体验,包括感知需求和社会支持。我们将进行一项随机对照试验:符合条件的急性轻微卒中或 TIA 患者(n = 40)将被随机分配到早期开始的咨询和出院后 12 周的四次随访或常规护理。主要结果将是计划的可行性,并讨论动脉血压作为 12 周干预后主要结果的相关性。选定的参与者将被邀请参加基于有目的抽样的半结构化访谈,评估干预措施并探索他们在中风后的生活体验。访谈将使用五步主题分析方法进行分析。该研究将提供证据,证明早期咨询对轻度卒中和 TIA 患者心血管危险因素的可行性和潜在影响。定性访谈将有助于更细致地了解促进健康行为的障碍和促进因素。优化健康行为咨询并为患者出院后提供正式支持可能会缓解过渡并帮助更多患者坚持生活方式和药物建议。ClinicalTrial.gov,NCT03648957 该研究将提供证据,证明早期咨询对轻度卒中和 TIA 患者心血管危险因素的可行性和潜在影响。定性访谈将有助于更细致地了解促进健康行为的障碍和促进因素。优化健康行为咨询并为患者出院后提供正式支持可能会缓解过渡并帮助更多患者坚持生活方式和药物建议。ClinicalTrial.gov,NCT03648957 该研究将提供证据,证明早期咨询对轻度卒中和 TIA 患者心血管危险因素的可行性和潜在影响。定性访谈将有助于更细致地了解促进健康行为的障碍和促进因素。优化健康行为咨询并为患者出院后提供正式支持可能会缓解过渡并帮助更多患者坚持生活方式和药物建议。ClinicalTrial.gov,NCT03648957 优化健康行为咨询并为患者出院后提供正式支持可能会缓解过渡并帮助更多患者坚持生活方式和药物建议。ClinicalTrial.gov,NCT03648957 优化健康行为咨询并为患者出院后提供正式支持可能会缓解过渡并帮助更多患者坚持生活方式和药物建议。ClinicalTrial.gov,NCT03648957
更新日期:2020-04-22
down
wechat
bug