Tailored Diabetes Self-Management Resources
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Children with type 1 diabetes face complex self-management regimens which make adherence
      challenging and ultimately result in poor blood sugar control. Several common barriers
      interfere with diabetes control such as limited knowledge or challenges with staying
      motivated. Efficacious strategies exist to improve diabetes self-management including, but
      not limited to, diabetes education or family therapy. Patients and families often do not
      access these strategies, in part due to healthcare systems-based issues such as
      accessibility, provider availability, or insurance coverage.

      A family-centered approach has been suggested to tailor diabetes care to provide improved
      outcomes for each child. Family-centered care engages the family in the decision-making about
      the child's health and well-being. In this study we will take a family-centered approach to
      providing diabetes self-management by identifying families' unique self-management barriers
      through a 10-minute survey tool called PRISM (Problem Recognition in Illness
      Self-Management). Based upon the results of PRISM, we will provide tailored self-management
      resources (interventions) to meet the family's needs. We will coordinate group-based delivery
      of the resources with routine diabetes clinic visits. These group-based resources will be
      delivered in four 75-minute sessions over a year.

      The primary goal of this study is to compare the effectiveness of family-centered tailoring
      of diabetes self-management resources with the untailored approach of usual care. We
      hypothesize that the family-centered model of care with tailored resources will improve the
      outcomes of glycemic control and quality of life among children with type 1 diabetes and
      their parents.
    

Detailed description: 
      This project's long-term goal is to develop a system-level method to move existing,
      efficacious self-management resources into the hands of children with type 1 diabetes and
      their families. Over 175,000 US children have type 1 diabetes and face a lifetime of
      self-management decisions in an attempt to delay or prevent complications, avoid
      hypoglycemia, and maintain quality of life for themselves and their parents. Although
      efficacious self-management resources exist, most children with diabetes struggle to manage
      their disease. Several barriers to diabetes management exist, including knowledge,
      motivation, and family interactions. Because barriers are unique for each child and family,
      family-centered approaches are recommended. Currently, no systematic approach exists to
      identify and address each family's self-management barriers. Information from PRISM (Problem
      Recognition in Illness Self-Management), a 10-minute survey tool, could help families and
      clinicians make better decisions to address these barriers, ultimately improving outcomes,
      fostering family-centered diabetes care, and optimizing resource use.

      This randomized, pragmatic trial will compare outcomes from PRISM-based, family-centered
      tailoring of self-management resources (intervention) to outcomes from the untailored
      approach of usual care. Our specific aims are to assess the effect of family-centered
      tailoring of diabetes self-management resources on outcomes that matter to the children and
      parents: glycemic control (A1c and fear of hypoglycemia) and child and parent quality of
      life.

      Children 8-16 years old with diabetes (150 each in usual care and intervention groups) and
      their parents will be enrolled at two large pediatric diabetes clinics. We will 1) use PRISM
      to identify families' unique self-management barriers; 2) tailor self-management resources to
      identified barriers; and 3) coordinate group-based delivery of the resources with routine
      diabetes visits. The group-based resources will be delivered in four 75-minute sessions over
      12 months. A1c will be assessed after sessions, along with fear of hypoglycemia and quality
      of life for the child and parent. We will compare outcomes with mixed-effects models.
    

Intervention name(s): Tailored Resources
Intervention type(s): Behavioral
Intervention description(s): Based upon PRISM screening tool results that identifies self-management barriers, patient/family will receive self-management resources matched to their barriers. These resources could be focused on: 1. Understanding and organizing care; 2. Motivation to self-manage; and 3. Family Teamwork. Group session of about 6 families with the same barrier will meet four times fo 75-minutes over a year, at the clinic site on same date as routine clinic visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Family centered care; Patient centered care; Diabetes Mellitus, Type 1; Problem Recognition in Illness Self-Management (PRISM)