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

University of Southern California

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Resilient, Empowered, Active Living-Telehealth (REAL-T)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04023487

1R01DK116719 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T1D for ≥12 months
• A1c ≥7.5% at time of study enrollment
• Age 18-30 yrs. at time of study enrollment
• English or Spanish speaking
• Resides in a state where OT clinicians are licensed, in an area where the participant has access to a local healthcare provider in the event of emergency and can complete data collection in person (when permitted) or via mailings (when required during period of social distance or due to distance from study site)
• Participant has access to a laptop or desktop computer, either their own or loaned by the study (if geographically feasible and permitted given COVID-19 social distancing distractions)
• Willing to participate in 6-month intervention

Exclusion criteria

• Currently pregnant or planning to become pregnant within the next 12 months
• Previously received REAL intervention
• Cognitive impairment or severe disability limiting life expectancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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209 participants in 2 patient groups

Lifestyle Intervention

Experimental group

Description:

Resilient, Empowered, Active Living-Telehealth (REAL-T)

Treatment:

Behavioral: Resilient, Empowered, Active Living-Telehealth (REAL-T)

Usual Care

No Intervention group

Description:

Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.