A Pilot Randomized Controlled Clinical Trial to Improve Adherence Barriers for Adolescents with Type 1 Diabetes.

Abstract

To examine feasibility, acceptability, satisfaction, and preliminary efficacy of Diabetes Journey (DJ), a randomized controlled clinical trial for 12- to 17-year-old adolescents with type 1 diabetes (T1D). Adolescents (n = 162; M_age = 14.8 ± 1.6 years; 56.4% female) who exceeded the clinical cut-point on the Barriers to Diabetes Adherence (BDA) questionnaire were randomized to DJ (amusement park-themed web modules) or enhanced standard of care (ESC; T1D education toolkit). Data were collected across 9 months, including baseline, posttreatment, follow-up 1 (3 months posttreatment), and follow-up 2 (6 months posttreatment). Primary outcomes were acceptability, feasibility, satisfaction, and BDA Stress/Burnout and Time Pressure/Planning scores at follow-up 1. Secondary outcomes were glycosylated hemoglobin A1c and quality of life. The group × time interaction was significant for the BDA Stress/Burnout subscale. Compared with ESC, the DJ group demonstrated a modest but statistically significant reduction in Stress/Burnout (b = -0.36, P < .05, 95% CI -0.72 to -0.01) and improvements in T1D quality of life (b = 7.09, P = .03, 95% CI 0.59-13.59). No significant differences occurred between groups for time pressure/planning. Adolescents and caregivers in DJ reported greater satisfaction than those in ESC. Our preliminary findings suggest that DJ had high acceptability, feasibility, and satisfaction. Adolescents randomized to DJ showed signals of reduced stress and burnout and improved quality of life at later follow-up, although these findings should be interpreted cautiously given attrition and the optional nature of the final follow-up assessment. www. gov NCT04404556.