Challenging Recruitment of Youth With Type 2 Diabetes Into Clinical Trials

Abstract

Purpose To better understand and overcome difficulties with recruitment of adolescents with type 2 diabetes into clinical trials at three United States institutions, we reviewed recruitment and retention strategies in clinical trials of youth with various chronic conditions. We explored whether similar strategies might be applicable to pediatric patients with type 2 diabetes. Methods We compiled data on recruitment and retention of adolescents with type 2 diabetes at three centers (National Institutes of Health, Bethesda, Maryland; Baylor College of Medicine, Houston, Texas; and Children’s National Medical Center, Washington, DC) from January 2009 to December 2011. We also conducted a thorough literature review on recruitment and retention in adolescents with chronic health conditions. Results The number of recruited patients was inadequate for timely completion of ongoing trials. Our review of recruitment strategies in adolescents included monetary and material incentives, technology-based advertising, word-of-mouth referral, and continuous patient–research team contact. Cellular or Internet technology appeared promising in improving participation among youths in studies of various chronic conditions and social behaviors. Conclusions Adolescents with type 2 diabetes are particularly difficult to engage in clinical trials. Monetary incentives and use of technology do not represent “magic bullets,” but may presently be the most effective tools. Future studies should be conducted to explore motivation in this population. We speculate that (1) recruitment into interventional trials that address the main concerns of the affected youth (e.g., weight loss, body image, and stress management) combined with less tangible outcomes (e.g., blood glucose control) may be more successful; and (2) study participation and retention may be improved by accommodating patients’ and caregivers’ schedules, by scheduling study visits before and after working hours, and in more convenient locations than in medical facilities.

Patient Perspectives on Peer Mentoring

“…There is some evidence for great difficulty in recruiting youth for any type of diabetes-related intervention, especially among minorities. 40,41 …”

Using e-technologies in clinical trials

“…Two additional studies with younger participants also found preferences for e-technologies. In a study of youth with Type 2 diabetes, Nguyen and colleagues (2014) found that monetary incentives and technological approaches (mobile phones and websites) were the most effective strategies to engage and retain participants. In contrast, patients with rheumatoid arthritis, with a mean age of 61 years, preferred to complete research surveys via regular mail, followed by telephone, with the Internet identified as their least preferred method (Garcia et al, 2014).…”

Correlates of Medication Adherence in the TODAY Cohort of Youth With Type 2 Diabetes

“…There is a dearth of information in the literature regarding adherence to medication in pediatric patients with type 2 diabetes. One report (10) from a study of youth with type 2 diabetes at three clinical sites concluded that “compliance with medications and doctor’s appointments is suboptimal in youth with type 2 diabetes.” The objective of the current analysis was to identify factors that predicted medication adherence and to examine relationships among adherence, glycemic control, and indices of insulin action in the TODAY cohort.…”