Background: 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.
Main body: 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).
Conclusion: 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.
Trial registration: 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 .
Keywords: Complementary alternative medicine; Engagement; Multiple sclerosis; Recruitment; Remote exercise; Stakeholder; Tele-exercise; Telerehabilitation.
The Tele Exercise and Multiple Sclerosis (TEAMS) study has been able to successfully screen over 1700 people with multiple sclerosis (MS) across three southern states (Alabama, Mississippi, Tenessee) largely due to the advice and input that the research team received from a stakeholder panel, clinic partners and community organizations. These groups met before the study was submitted for funding to the Patient-Centered Outcome Research Institute (PCORI), and was awarded in 2017. These engagement stages and framework established early in the study process were instrumental in generating strong enthusiasm for the study among various MS constituency groups. The feedback from our stakeholders, clinic partners, and community organizations led to the creation of a variety of recruitment methods (print material, email, social media, attendance at events, and health fairs) to connect with potential participants in a setting convenient within each location. In approximately 26 months, the study enrolled 837 participants with MS and baseline tested 759 individuals who participated in a rehabilitative exercise program at either a clinic site or in their home using a tablet that they were given (and kept) which included a set of preloaded videos. All milestones established by PCORI and research staff were met, leading to the largest exercise trail ever conducted with people with MS.
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