Challenges with engaging participants in behavioral intervention research trials

Abstract

David Olem, Kelly M Sharp, Mallory O JohnsonDepartment of Medicine, University of California, San Francisco, CA, USAAbstract: In clinical trials research, nonadherence to an investigational health promotion intervention poses threats to internal validity, thus raising concern over the trial outcomes and interpretation of results. Successfully helping participants to engage in and complete a multisession intervention can be particularly challenging. This task can become more complicated when working with participants who are dealing with chronic health conditions and are from diverse cultural, socio-economic, and marginalized backgrounds who may have competing needs, beliefs, and priorities that conflict with the needs of the trial protocols. This paper identifies some of the challenges to helping individuals participate in the sessions of a behavioral intervention and shares a set of strategies developed by a clinical research team to engage with participants and minimize barriers to completing the intervention.Keywords: clinical trials, behavioral interventions, retention, internal validit