Feasibility of Delivering a Complex Behavioral Intervention for Young Adults With Diabetes Via Telehealth
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The
      Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will evaluate the feasibility
      of implementing a diabetes management intervention via telehealth in preparation for a
      large-scale randomized controlled trial (RCT) entitled Evaluation of a Complex Behavioral
      Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active
      Living-Telehealth (REAL-T) Study.
    

Detailed description: 
      Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The
      Resilient, Empowered, Active Living-Telehealth (REAL-T) feasibility study will evaluate the
      feasibility of implementing a diabetes management intervention via telehealth in preparation
      for a large-scale RCT.

      Young adulthood is a challenging life stage for many individuals with diabetes; only 17% of
      YAs age 18-25 and 30% age 26-30 attain recommended A1C targets, and fewer than 1/3 perform
      self-care in accordance with national guidelines. Yet, it is a crucial stage for establishing
      health habits that persist throughout adulthood. To address these issues, our research team
      developed REAL Diabetes (Resilient, Empowered, Active Living with Diabetes), a 6-month
      individually tailored occupational therapy intervention focused on incorporating diabetes
      self-care into participants' daily habits and routines, and evaluated its efficacy in a pilot
      randomized controlled trial (n=81). REAL was shown in intention-to-treat analysis to
      significantly improve A1C (0.9% reduction; p=0.01) and diabetes-related quality of life
      (p=0.04). While REAL was highly promising in terms of its positive impact on health and
      quality of life, the intervention was delivered through home visits, limiting its potential
      for broad dissemination. Given that our target population experiences significant logistical
      barriers to clinic attendance (the impetus for our in-home treatment model), we therefore
      will adapt REAL to be delivered via telehealth (REAL-T), a highly promising care delivery
      model, and evaluate REAL-T in a large-scale RCT.

      The current feasibility study will evaluate the feasibility of implementing the REAL-T
      intervention via telehealth by enrolling 10 participants who are 18-30 years of age,
      conducting the REAL-T intervention with all participants over a 3-month period, and assessing
      the process of implementing the study (feasibility and participant satisfaction).
    

Intervention name(s): REAL-T Intervention
Intervention type(s): Behavioral
Intervention description(s): Individualized lifestyle intervention conducted via internet-based videoconferencing and incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants will have approximately 6-10 sessions lasting about one hour each, over a 3-month period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other