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

Diabetes Mellitus, Type 1 Clinical Trial

Official title: Evaluation of a Complex Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study

Status Completed

Clinical Trial Summary

This study will evaluate (1) the efficacy of REAL-T, a lifestyle-based telehealth intervention, in improving glycemic control (HbA1c) and psychosocial outcomes, (2) which effects are retained over a 6-month follow-up period, and (3) the mediating mechanisms responsible for the intervention's effects. Half of participants will receive REAL-T, while the other half will receive their usual care.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

• NCT number: NCT04023487
• Study type: Interventional
• Source: University of Southern California
• Status: Completed
• Phase: N/A
• Start date: October 22, 2019
• Completion date: November 18, 2023