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

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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 c...

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.

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