Study Shares Successful Recruitment Strategies for MS Exercise Trial

By engaging a variety of stakeholders from across the multiple sclerosis (MS) community, researchers in the U.S. Deep South were able to enroll more than 800 patients to a clinical trial in just over two years in what’s considered the largest study of an exercise intervention in MS patients to date.

The trial is testing an in-person physical exercise program against the same program delivered via online videos.

The strategies leading to this successful patient recruitment are described in the study “Supporting successful recruitment in a randomized control trial comparing clinic and home-based exercise among adults with multiple sclerosis,” published in Research Involvement and Engagement.

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One of the biggest challenges in running clinical trials of exercise for people with disabilities, such as those with MS, is recruiting enough participants.

Enrollment difficulties can lead to increased trial costs, as well as give studies less statistical power to detect outcomes and limit the generalizability of their results. On average, studies testing exercise in MS enroll fewer than 50 participants.

Now, researchers at the University of Alabama at Birmingham, the Tanner Foundation for Neurological Diseases, and MS patients described the strategies that led “to the largest exercise rehabilitation trial ever conducted on people with MS,” they wrote.

In 2018, the university launched a clinical trial, called Tele-Exercise And Multiple Sclerosis, or TEAMS (NCT03117881), to evaluate the effects of a 12-week exercise intervention when given either in-person or virtually for people diagnosed with MS.

The ongoing study seeks to enroll 820 MS patients in three states in the U.S. Deep South: Alabama, Mississippi, and Tennessee.

Over the course of about 26 months — just over two years — more than 1,700 people with MS were screened, and 837 were ultimately recruited into the trial.

Six-step process for successful clinical trial recruitment

This was the result of a six-step process incorporating stakeholder engagement and a new participant recruitment method.

The first step involved finding a diverse group of stakeholders in the MS community in the three states.

This included a panel of nine people with relevant expertise: caregivers, exercise specialists, government officials, scientists, healthcare professionals, and non-profit employees. Five of them also lived with MS.

Stakeholders also included nearly 90 physical and occupational therapists and assistants, as well as hospital systems, neurology and primary care practices, and community organizations such as the National MS Society, Multiple Sclerosis Foundation, and MS Association of America.

The second step was establishing regular channels of communication with stakeholders, and the third step was working with them to establish recruitment strategies that varied from state to state and between urban and rural areas.

“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,” the researchers wrote.

In some rural areas, churches were identified as the best places to spread the word about the trial, while coffee shops served that purpose in urban areas. A trial logo and website were created, as well as a brochure and a flyer.

The fourth step was implementation of these strategies, opening the study to patient recruitment.

Brochures and flyers were spread “in the areas identified by the stakeholders either in printed versions in physician waiting rooms, through mailings to homes, and/or social media posts made by organization partners,” the team wrote.

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The fifth and sixth steps consisted of continually collecting recruitment data, looking for new avenues for improvement, and reporting outcomes back to the Patient Centered Outcomes Research Institute, the agency that funded the study.

“When querying our database on how participants found out about the study, the highest response was through a study flyer, followed by word of mouth, and through clinic staff,” the researchers wrote.

“The recruitment numbers reflect the importance of involving multiple stakeholder groups at project development, maintaining relationships over time, utilizing member strengths, and monitoring their engagement on a regular basis to ensure a meaningful experience for all involved,” they added. “Building trust among existing community systems served as a key element of success in this research project.”

The TEAMS trial is set to be completed in January 2023.