Resilient, Empowered, Active Living: REAL Diabetes Study
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This three-year award will pilot-test an innovative intervention, Resilient, Empowered,
      Active Living with Diabetes (REAL), targeting underserved minority young adults with
      poorly-controlled diabetes. The individually tailored, community-based intervention merges
      findings of an in-depth needs assessment, principles of an evidence-based occupational
      therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management
      strategies. A proof-of-concept study demonstrated that REAL is feasible to implement,
      acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to
      produce positive changes in diabetes self-care and glycemic control. The study will randomize
      80 young adults with diabetes to receive either the six-month REAL intervention or an
      attention control condition. Blinded data collectors will assess glycemic control, diabetes
      self-care behaviors and quality of life outcomes, as well as potential intervention
      mediators, before and after the six-month intervention. It is anticipated that findings from
      this pilot study will be used to inform a large-scale randomized controlled trial of the REAL
      intervention.

      The study's specific aims and hypotheses are as follows:

      Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and
      diabetes self-care.

      Hypothesis: At 6 months (immediately following the intervention), intervention group
      participants will demonstrate improvements in A1C and diabetes self-care as compared to
      control group participants.

      Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and
      potential mediating mechanisms (to inform power estimates for a large-scale RCT).

      Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in
      secondary outcomes: diabetes-related stress and quality of life, depression, and life
      satisfaction as compared to control group participants.

      Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in
      potential mediators of the intervention: habit strength, problem solving, activity
      participation, self-efficacy and diabetes knowledge as compared to baseline.

      Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine
      intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures
      (e.g. recruitment, retention, testing protocol).
    


Intervention name(s): Resilient, Empowered, Active Living with Diabetes; Information Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individualized lifestyle intervention 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 receive a total of 10-16 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the REAL Diabetes intervention protocol.; Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose. The packet of materials will be delivered in an initial home visit. Follow-up phone calls will occur at approximately two week intervals to inquire whether participants have reviewed specific sections of the intervention materials, and clarify information included in the packet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment