Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Resilient, Empowered, Active Living-Telehealth (REAL-T)
Intervention type(s): Behavioral
Intervention description(s): REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1, randomized controlled trial