New findings from FM-TIPS show that targeted community engagement methods are highly effective in increasing recruitment and enrollment, particularly among rural participants who are typically underrepresented in clinical research.

The report was published online in the Journal of Clinical and Translational Science.

FM-TIPS, an NIH Collaboratory Trial, is a cluster randomized trial examining whether adding transcutaneous electrical nerve stimulation to routine physical therapy improves outcomes for patients with fibromyalgia receiving care in physical therapy clinics. Recruitment for clinical trials often faces barriers in rural communities, which make up 19% of the US population but experience a significant burden of chronic pain, including fibromyalgia.

To address projected low enrollment rates in certain locations, the FM-TIPS study team implemented specific community engagement strategies partway through the trial for 2 groups: targeted rural clinics and targeted low-enrollment clinics. They compared these groups to a group of untargeted clinics.

The initiative was guided by 2 full-time community engagement coordinators who tailored a multipronged approach for each local community. Strategies included posting individualized flyers in public spaces, conducting physician outreach, and using social media ads and direct mail campaigns. Key to the initiative’s success was establishing strong partnerships with local physical therapy clinics and their staff, who served as trusted community members.

Implementation of these strategies resulted in a significant increase in study inquiries, screening, and enrollment. Average monthly inquiries across all clinics rose from 2 per month to 28, a 760% increase over projected numbers. The most effective strategies for generating inquiries were social media ads and direct mail.

When comparing actual enrollment to projected enrollment, the community engagement efforts boosted enrollment by 23% in the targeted rural clinics and 107% in the targeted low-enrollment clinics. There was no significant increase in enrollment in the untargeted group.

The strategies also successfully increased the enrollment of rural residents. Notably, 99% of rural residents who passed screening went on to enroll in the study, compared to only 32% of urban residents who passed screening—highlighting the rural participants’ high willingness to join the research once barriers were addressed.

“These findings contribute to a growing body of research demonstrating that pragmatic trials, when combined with strong community engagement, can help bridge healthcare disparities in rural populations,” the authors wrote.

Read the full report.

FM-TIPS is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through the NIH HEAL Initiative. Learn more about FM-TIPS.