Journal article
Community Engagement Strategies Improve Recruitment and Enrollment in a Pragmatic Clinical Trial
Journal of clinical and translational science, Vol.9(1), e184
07/24/2025
DOI: 10.1017/cts.2025.10103
PMCID: PMC12444702
PMID: 40979091
Appears in UI Libraries Support Open Access
Abstract
Introduction: Rural communities make up 19% of the US population, yet are underrepresented in clinical trials. Community engagement methods can facilitate collaboration and trust with local healthcare personnel to enhance enrollment. The purpose of this manuscript is to describe community engagement methods and their impact on enrollment in a pragmatic clinical trial. Methods: We describe a variety of methods used in the Fibromyalgia TENS in Physical Therapy Study (FM-TIPS) to enhance enrollment in rural communities and low enrolling clinics. Community engagement methods were implemented partway through the trial for selected groups: Targeted Rural (TR)(n=10), Targeted Low Enrolling (TLE)(n=6), and compared to Untargeted Groups (UT)(n=13). The impact of these methods on inquiries, screening and enrollment were evaluated by comparing actual enrollment to projected enrollment. Results: We trained and employed community engagement coordinators to implement strategies in TR and TLE physical therapy clinics. These included, posting flyers, community events, physician outreach, social media ads and direct mailing. These methods increased study inquiries, screening and enrollment in the study. Specifically, when compared to projected values there were increases in enrollment for both the TR and the TLE groups, but not the UT group. Of those that passed screening 99% of rural and 32% of urban residents enrolled in the study. Conclusion: A multi-pronged and individualized community engagement approach can increase enrollment of rural residents in clinical trials. Building strong relationships and partnering with community clinics and local communities is essential to success.
Details
- Title: Subtitle
- Community Engagement Strategies Improve Recruitment and Enrollment in a Pragmatic Clinical Trial
- Creators
- Kari G. Vance - University of IowaJonah Pedelty - University of IowaBarbara J. Van Gorp - University of IowaCarol GT VanceElizabeth M. Johnson - University of IowaFangfang Jiang - University of IowaDavid-Erick Lafontant - University of Iowa, BiostatisticsMaxine KoeppAndrew A. PostEmine O. Bayman - University of IowaRuth L. Chimenti - University of Iowa, Physical Therapy and Rehabilitation ScienceDana L. DaileyLeslie J. CroffordHeather Schacht Reisinger - University of IowaKathleen A. Sluka
- Resource Type
- Journal article
- Publication Details
- Journal of clinical and translational science, Vol.9(1), e184
- DOI
- 10.1017/cts.2025.10103
- PMID
- 40979091
- PMCID
- PMC12444702
- NLM abbreviation
- J Clin Transl Sci
- ISSN
- 2059-8661
- eISSN
- 2059-8661
- Publisher
- Cambridge University Press; CAMBRIDGE
- Number of pages
- 32
- Copyright
- © The Author(s), 2025
- Grant note
- National Institutes of Health: UH3/UG3AR076376, UH3AR076387-S3 National Center for Advancing Translational Sciences of the National Institutes of Health: UM1TR004403
Research reported in this publication was supported by the National Institutes of Health UH3/UG3AR076376 and UH3AR076387-S3, and National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UM1TR004403.
- Language
- English
- Date published
- 07/24/2025
- Academic Unit
- Iowa Neuroscience Institute; Biostatistics; Nursing; Center for Social Science Innovation; Anesthesia; Physical Therapy and Rehabilitation Science; Neuroscience and Pharmacology; Internal Medicine
- Record Identifier
- 9984927216202771
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