想象研究协议的临床试验：一项多中心、研究者盲法、随机、36 个月、平行组比较动机访谈在老年脑卒中幸存者康复中的有效性。
IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors.
机构信息
REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron Institute of Research, Barcelona, Spain.
Autonomous University of Barcelona, Bellaterra, Spain.
出版信息
BMC Geriatr. 2020 Sep 4;20(1):321. doi: 10.1186/s12877-020-01694-6.
BACKGROUND
Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), as a person-centered complex intervention, aimed to empower and motivate, and could be a resource to improve rehabilitation outcomes for older stroke survivors. The IMAGINE project aims to assess the impact of MI, as a complement to standard geriatric rehabilitation, on functional improvement at 30 days after admission, compared to standard geriatric rehabilitation alone, in persons admitted to geriatric rehabilitation after a stroke. Secondary objectives include assessing the impact of MI on physical activity and performance, self-efficacy, safety, cost-utility, participants' experiences and functional status at 3 months.
METHODS
We will conduct a multicenter randomized clinical trial in three geriatric rehabilitation hospitals in Spain. Older adults after mild-moderate stroke without previous severe cognitive impairment or disability will be randomized into the control or intervention group (136 per group, total N = 272). The intervention group will receive 4 sessions of MI by trained nurses, including the design of a personalized rehabilitation plan agreed between stroke survivors and nurses based on stroke survivors´ goals, needs, preferences and capabilities. Main outcome will be the Functional Independence Measure (FIM). In-hospital physical activity will be measured through accelerometers and secondary outcomes using validated scales. The study includes a process evaluation and cost-utility analysis.
DISCUSSION
Final results are expected by end of 2020. This study will provide relevant information on the implementation of MI as a rehabilitation reinforcement tool in older stroke survivors. A potential reduction in post-stroke disability and dependence would increase person's health-related quality of life and well-being and reduce health and social care costs. IMAGINE has the potential to inform practice and policymakers on how to move forward towards shared decision-making and shared responsibilities in the vulnerable population of older stroke survivors.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03434938 , registered on January 2018.
背景
康复路径对于减少与中风相关的残疾至关重要。动机性访谈（MI）作为一种以患者为中心的复杂干预措施，旨在赋予患者权力并激发其动力，可能是改善老年中风幸存者康复效果的资源。IMAGINE 项目旨在评估 MI 的影响，作为对标准老年康复的补充，与单独进行标准老年康复相比，在中风后入住老年康复病房的患者中，在入院后 30 天的功能改善方面，与单独进行标准老年康复相比，MI 作为一种补充，在功能改善方面的影响，与单独进行标准老年康复相比，MI 作为一种补充，在功能改善方面的影响。次要目标包括评估 MI 对身体活动和表现、自我效能、安全性、成本效益、参与者体验以及 3 个月时的功能状态的影响。
方法
我们将在西班牙的三家老年康复医院进行一项多中心随机临床试验。轻度至中度中风且无先前严重认知障碍或残疾的老年人将被随机分配到对照组或干预组（每组 136 人，总人数为 272 人）。干预组将由经过培训的护士接受 4 次 MI，包括根据中风幸存者的目标、需求、偏好和能力，由中风幸存者和护士共同制定个性化康复计划。主要结局是功能性独立性测量（FIM）。住院期间的身体活动将通过加速度计进行测量，次要结局将使用经过验证的量表进行测量。该研究包括过程评估和成本效益分析。
讨论
预计最终结果将于 2020 年底公布。本研究将为 MI 作为老年中风幸存者康复增强工具的实施提供相关信息。减少中风后残疾和依赖将提高患者的健康相关生活质量和幸福感，并降低医疗保健和社会保健成本。IMAGINE 有可能为实践和决策者提供信息，说明如何在老年中风幸存者这一弱势群体中朝着共同决策和共同承担责任的方向前进。
试验注册
ClinicalTrials.gov：NCT03434938，于 2018 年 1 月注册。
Zotero 插件