Liljehult Jacob, Molsted Stig, Møller Tom, Overgaard Dorthe, Christensen Thomas
Department of Neurology, Nordsjællands Hospital, Dyrehavevej 29, Hillerød, 3400, Denmark.
Department 9701, The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, 2100, Denmark.
Pilot Feasibility Stud. 2024 Mar 22;10(1):50. doi: 10.1186/s40814-024-01478-4.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT03648957 . Registered 28 August 2018.
轻度中风或短暂性脑缺血发作的患者未来发生中风的风险增加。这些患者出院回家后往往缺乏专门的后续跟进，尽管近一半的患者存在认知缺陷。仅仅鼓励患者戒烟、进行体育锻炼并服用预防性药物往往不足以确保其依从性，需要更全面的干预措施来帮助患者养成健康行为。本研究的目的是在一项随机对照试验中，检验针对轻度中风或短暂性脑缺血发作患者，早期启动以患者为中心的干预措施对吸烟、体育锻炼和药物依从性的可行性和潜在效果。
将住院患者随机分为常规护理组或干预组，干预组包括基于5A模型的健康行为咨询、电话随访（4周和8周）以及体育活动监测。随访时间为12周。可行性评估涉及以下几个方面：入选资格、接受度、需求和实用性、依从性、损耗率以及实施和整合情况。
84名潜在合格患者中的40名被随机分配到两个治疗组（20名接受干预/20名接受常规护理）。32名患者完成了12周的随访，8名患者被排除或失访。干预措施几乎没有变化，按照方案实施是可行的。
有可能识别出可能从行为干预中获益的相关患者，在入院后早期招募并随机分配他们，使大多数参与者留在研究中直至随访结束，并得出统计估计值以指导大规模随机对照试验的设计。
ClinicalTrials.gov标识符：NCT03648957。于2018年8月28日注册。
