Journal article
Patient engagement in a pragmatic trial: Insights from the FM-TIPS trial
Journal of clinical and translational science, Vol.10(1), e173
09/28/2026
DOI: 10.1017/cts.2026.10835
Abstract
Introduction: Pragmatic trials are designed to test the effectiveness of an intervention in a real-world setting, which requires decentralized enrollment and data collection methods. Communication strategies may play an important role in supporting participant engagement, though evidence describing their implementation and impact in pragmatic trials is limited. The purpose of this study was to describe the impact of various communication strategies with participants on the rate of enrollment, baseline data completion, and retention rates in the Fibromyalgia TENS in Physical Therapy Study (FM-TIPS). Methods: We evaluated enrollment, baseline data completion, and retention in relation to implementation of different communication strategies for FM-TIPS, a cluster randomized pragmatic clinical trial. Communication strategies evolved iteratively over the course of the trial, ranging from automated reminders to reactive and proactive personalized contact by study staff. Results: Following implementation of the reactive communication plan, enrollment increased from 83% to 92%, and completion of Day 1 research homework increased from 67% to 81%. Following implementation of the proactive participant onboarding approach, including a welcome phone call and email, completion of Day 1 research homework increased to 89%. Retention at later time points improved following the introduction of automated reminders combined with targeted, personalized contact. Additional communication unrelated to enrollment and completion of research homework, such as troubleshooting technical issues, may have contributed to participant retention in the study. Conclusion: The addition of personalized communication strategies to regular automated reminders was associated with higher enrollment, baseline data completion, and participant retention in a decentralized pragmatic trial.
Details
- Title: Subtitle
- Patient engagement in a pragmatic trial: Insights from the FM-TIPS trial
- Creators
- Elizabeth M Johnson - Vanderbilt University Medical CenterDana L Dailey - University of IowaCarol G.T VanceBarbara J Van Gorp - University of IowaAndrew A Post - University of IowaRuth L Chimenti - University of Iowa, Physical Therapy and Rehabilitation ScienceKari G Vance - University of IowaDavid-Erick Lafontant - University of Iowa, BiostatisticsDixie Ecklund - University of IowaKristin R Archer - Vanderbilt University Medical CenterBridget M Zimmerman - University of Iowa, BiostatisticsEmine Bayman - University of IowaKathleen A Sluka - University of IowaLeslie J Crofford - Vanderbilt University Medical Center
- Resource Type
- Journal article
- Publication Details
- Journal of clinical and translational science, Vol.10(1), e173
- DOI
- 10.1017/cts.2026.10835
- ISSN
- 2059-8661
- eISSN
- 2059-8661
- Publisher
- Cambridge University Press
- Grant note
- National Institutes of Health (NIH) Pragmatic Trials Collaboratory through the NIH HEAL Initiative (KAS): UG3/UH3 AR076387 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Center for Advancing Translational Sciences of the National Institutes of Health: UM1TR004403 NIH HEAL Initiative: U24 AT010961 National Center for Complementary and Integrative Health (NCCIH) National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI) National Institute of Allergy and Infectious Diseases (NIAID) NIAMS National Institute of Minority Health and Health Disparities (NIMHD) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) National Institute on Aging (NIA) NIH Office of Behavioral and Social Sciences Research (OBSSR) NIH Office of Disease Prevention (ODP): U24 AT009676 NIA NHLBI NIMHD NINDS
This work was supported by the National Institutes of Health (NIH) Pragmatic Trials Collaboratory through the NIH HEAL Initiative (KAS, LJC, grant number UG3/UH3 AR076387), administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); the National Center for Advancing Translational Sciences of the National Institutes of Health (grant number UM1TR004403); and logistical and technical support from the PRISM Resource Coordinating Center through the NIH HEAL Initiative (grant number U24 AT010961), and from the NIH Pragmatic Trials Collaboratory Coordinating Center funded by the National Center for Complementary and Integrative Health (NCCIH), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Allergy and Infectious Diseases (NIAID), NIAMS, the National Institute of Minority Health and Health Disparities (NIMHD), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Nursing Research (NINR), the National Institute on Aging (NIA), the NIH Office of Behavioral and Social Sciences Research (OBSSR), and the NIH Office of Disease Prevention (ODP) (grant number U24 AT009676). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or its HEAL Initiative, or of NCCIH, NCI, NIA, NIAMS, NHLBI, NIAID, NIMHD, NINDS, NINR, OBSSR, or ODP.
- Language
- English
- Date published
- 09/28/2026
- Academic Unit
- Iowa Neuroscience Institute; Biostatistics; Nursing; Anesthesia; Physical Therapy and Rehabilitation Science; Neuroscience and Pharmacology
- Record Identifier
- 9985237506302771
Metrics
1 Record Views