Evaluation of an Intervention for Young Adults With Diabetes: resilient, Empowered, Active Living-Telehealth (REAL-T)

Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living‐Telehealth (REAL‐T) Study will address the unmet self‐management and psychosocial needs of young adults (YAs) with type 1 diabetes (T1D). We will conduct a large‐scale randomized controlled trial (n=210) to compare the 6‐month REAL‐T intervention to usual care in improving glycemic control (A1c and continuous glucose monitor‐derived measures), psychosocial well‐being, and hypothesized intervention mediators. In addition, we will perform health economic analyses to determine the extent to which REAL‐T is cost‐effective or produces cost savings. The study's specific aims are as follows: Aim 1: Evaluate the efficacy of REAL‐T in improving glycemic control and psychosocial well‐being. ‐ Hypothesis 1: Over a 6‐month intervention period (including 3 and 6 month measures), YAs with T1D who receive REAL‐T demonstrate improvements in glycemic control, in comparison to YAs with T1D who receive usual care. ‐ Hypothesis 2: Over a 6‐month period (including 3 and 6 month measures), YAs with T1D who receive REAL‐T demonstrate gains in psychosocial well‐being in comparison to YAs with T1D who receive usual care. Aim 2: Assess the post‐intervention durability (at 3 and 6 months post‐intervention) of REAL‐T's effects on glycemic control and psychosocial well‐being. ‐ Hypothesis 1: Among YAs with T1D, improvements in glycemic control that result from REAL‐T relative to usual care are maintained at 3 and 6 months post‐treatment. ‐ Hypothesis 2: Among YAs with T1D, improvements in psychosocial well‐being that result from REAL‐T relative to usual care are maintained at 3 and 6 months post‐treatment. Aim 3: Examine mediating mechanisms of the REAL‐T intervention's effects on glycemic control and psychosocial well‐being through structural equation modeling (SEM). ‐ Hypothesis 1: Improvements in diabetes self‐care behaviors mediate positive intervention effects on glycemic control and psychosocial well‐being. ‐ Hypothesis 2: Improvements in self‐efficacy mediate positive intervention effects on psychosocial well‐being and partially mediate positive effects on diabetes self‐care behaviors. ‐ Hypothesis 3: Improvements in habit strength for diabetes self‐care behaviors partially mediate positive intervention effects on the performance of diabetes self‐care behaviors.