Tracy Tracy Flemming, Young Hui-Ju, Lai Byron, Layton Beverly, Stokes Dolly, Fry Mark, Mehta Tapan, Riser Emily S, Rimmer James
Tanner Foundation for Neurological Diseases, Birmingham, AL, 35209, USA.
UAB/Lakeshore Research Collaborative, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
Res Involv Engagem. 2022 Jul 29;8(1):35. doi: 10.1186/s40900-022-00366-6.
The Tele- Exercise and Multiple Sclerosis (TEAMS) study, funded by the Patient Centered Outcome Research Institute (PCORI), is a pragmatic, cluster randomized controlled trial aimed at comparing the effectiveness of a 12-week complementary and alternative medicine (CAM) program for people with multiple sclerosis (MS) delivered by a therapist at a clinic and the same program initiated by the participant at home using a tablet and pre-recorded videos. The 20-session CAM program consists of yoga, Pilates and dual tasking exercises. The study aimed to enroll 820 participants with MS living in Alabama, Mississippi and Tennessee.
The information provided in this paper describes the strategies that led to the largest randomized controlled exercise trial ever conducted for people with multiple sclerosis. Specifically, the paper presents the result of incorporating stakeholder engagement, a novel participant recruitment method, to produce a successful recruitment outcome for a comparative effectiveness randomized controlled trial. This study used three tiers of engagement: panel members (9 members), clinical partners (88 occupational and physical therapists), and community organizations (6 non-profits).
Engagement of the stakeholder panel, clinical partners and community organizations led to interest of over 1700 people with MS across three states in the Deep South (final enrollment was n = 837). The diversity of our stakeholder groups and their extensive reach into various communities were a critical aspect for achieving our target sample size. The recruitment numbers reflect the importance of involving multiple stakeholder groups at project inception, developing relationships over time, utilizing member strengths, and monitoring their engagement on a regular basis to ensure a meaningful experience for all involved.
NCT03117881. Registered 18 April 2017, https://clinicaltrials.gov/ct2/show/NCT03117881?term=tele+rehabilitation&cond=Multiple+Sclerosis&cntry=US&state=US%3AAL&draw=2&rank=1 .
由患者为中心的结果研究机构（PCORI）资助的远程锻炼与多发性硬化症（TEAMS）研究，是一项务实的整群随机对照试验，旨在比较由诊所治疗师为多发性硬化症（MS）患者提供的为期12周的补充和替代医学（CAM）项目，与参与者在家中使用平板电脑和预录制视频启动的相同项目的有效性。这个为期20节的CAM项目包括瑜伽、普拉提和双重任务练习。该研究旨在招募820名居住在阿拉巴马州、密西西比州和田纳西州的MS患者。
本文提供的信息描述了促成有史以来针对多发性硬化症患者开展的最大规模随机对照运动试验的策略。具体而言，本文呈现了纳入利益相关者参与（一种新颖的参与者招募方法）以在比较效果随机对照试验中取得成功招募结果的成果。本研究采用了三层参与方式：专家小组（9名成员）、临床合作伙伴（88名职业和物理治疗师）以及社区组织（6个非营利组织）。
利益相关者专家小组、临床合作伙伴和社区组织的参与使得美国南部腹地三个州的1700多名MS患者产生了兴趣（最终入组人数为n = 837）。我们利益相关者群体的多样性及其对各个社区的广泛影响是实现目标样本量至关重要的一个方面。招募人数反映了在项目启动时让多个利益相关者群体参与、随着时间推移建立关系、利用成员优势以及定期监测他们的参与情况以确保所有相关人员都有意义体验的重要性。
NCT03117881。于2017年4月18日注册，https://clinicaltrials.gov/ct2/show/NCT03117881?term=tele+rehabilitation&cond=Multiple+Sclerosis&cntry=US&state=US%3AAL&draw=2&rank=1 。
