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Barriers influencing pre-enrollment withdrawal in randomized clinical trials: Reflections of participants who did not complete screening for a smart technology-based weight loss study

Anmol Singh, Jacob Kariuki, India Loar, Britney Beatrice, Susan Sereika, Mia Cajita, Lora E Burke, University of Pittsburgh, School of Nursing, 3500 Victoria St, Pittsburgh, PA 15213 Bambang Parmanto, Wayan Pulantara, Yuhan Wang, University of Pittsburgh, School of Health and Rehabilitation Sciences, 4028 Forbes Tower, Pittsburgh, PA 15260 Jessica Cheng, University of Pittsburgh, Graduate School of Public Health, 130 De Soto Street, Pittsburgh, PA 15261 Molly B. Conroy, Maribel Cedillo, University of Utah, School of Medicine, 30 N. 1900 E, Salt Lake City, Utah 84132

Background: Randomized clinical trials (RCTs) frequently face the arduous task of recruitment. Often, a small percentage of potential participants who express initial interest in RCTs do not proceed to enrollment even when they meet eligibility criteria. These challenges prolong recruitment and may undermine the statistical power of the study if the anticipated sample is not recruited. Currently, there is a paucity of data on study related factors and other barriers that diminish potential participant’s enthusiasm in RCTs before they complete the screening process. In this study, we intended to bridge this gap by exploring barriers influencing pre-enrollment withdrawal in our RCT.

Methods: The SMARTER trial is a single-site, 12-month RCT with subjects randomized 1:1 to either: self-monitoring group (subjects self-monitor diet, physical activity, and weight using a smartphone app) or self-monitoring with feedback group (self-monitor and receive real-time, tailored feedback). Study investigators developed a questionnaire to collect data from participants who did not complete the screening phase of the study. Responses were organized in themes and descriptive statistics analyzed using STATA. 

Results: The 60 survey respondents (19.9% response rate) were predominantly female (88.9%), white (85.7%) and unemployed (69.8%), with a mean age of 43.8 (15.2). The primary reasons for withdrawal included study procedures (41.7%) and personal issues (18.3%). Four main themes emerged from the participant responses: time constraints, communication challenges, lack of upfront clarity concerning study procedures, and technological issues. Participants suggested solutions to reduce barriers, including multiple screening locations, varied modes of communication (e.g., option to receive text message instead of voicemail), and more clarity about study requirements and technology. There was no difference in themes by gender, race or employment status.

Conclusion: Providing clear channels of communication, simplifying screening protocols, and clarifying study procedures and technology could help sustain potential participants’ interest in enrolling in RCTs.




Additional Abstract Information

Presenter: Anmol Singh

Institution: University of Pittsburgh School of Nursing

Type: Oral

Subject: Nursing & Public Health

Status: Approved


Time and Location

Session: Oral 6
Date/Time: Tue 2:00pm-3:00pm
Session Number: 628
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