Peer Support for Achieving Independence in Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypotheses that CHWs providing in-home support for
      self-management of type 2 diabetes, resources for diabetes, and assistance in effective
      linkage and communication with medical providers will: (1) improve HbA1c (primary outcome)
      and secondary outcomes including lipids, blood pressure, health care utilization, and
      health-related quality of life; (2) improve diabetes self-management, including
      self-efficacy, physical activity, nutrition, and medication adherence; and (3) be
      cost-effective and feasible.
    

Detailed description: 
      The investigators will implement a randomized trial that will enroll 286 participants, from
      three different sites, to compare a CHW intervention consisting of home visits, telephone
      support, and linkage to appropriate community-based group activities compared to usual care.
      Usual care is defined as the medical care received by participants in the absence of the
      intervention plus information about community resources that support diabetes self-management
      (such as classes and support groups) plus educational pamphlets. The investigators will
      randomize an equal number of participants to the intervention and control groups.

      After collecting baseline data, we will assign participants to study groups using a
      stratified, permuted block design with varying block size. The investigators will stratify by
      site to ensure an approximately equal number of treatment and control subjects at each site
      and also meet the site-specific recruitment targets. The nature of the intervention makes it
      impossible to blind participants and staff to group assignment.

      CHWs will primarily work with participants in their homes, and will also link them to
      community resources that support self-management. CHWs will make up to 5 home visits for each
      participant in the intervention arm. To assure that the program is feasible to implement in a
      variety of clinical settings, to assure external validity of the study, and to assess
      potential for adoption, the CHWs will be based at the local public health department and
      participants will be recruited from a county hospital system, a community clinic and a
      Veteran Affairs (VA) hospital.

      Specific aims of the proposal are to examine the effect of the intervention on physiologic
      markers of disease control (HbA1c, lipids, blood pressure), participant self-efficacy,
      self-management behaviors quality of life and utilization and costs. The investigators will
      measure other demographic, medical and psychosocial patient level characteristics that could
      potentially modify the effects of the intervention. At the end of the study period, CHWs will
      visit usual care participants so that they receive many of the potential benefits received by
      intervention group members.

      The investigators will use mixed methods to assess translation of the research models into
      practice.
    

Intervention name(s): Community Health Worker Intervention
Intervention type(s): Behavioral
Intervention description(s): For the intervention group, a trained Community Health Worker (CHW) will provide education, support and service coordination through in-home visits. The CHW will first make an in-home assessment visit. At the assessment visit, the participant has the opportunity to ask questions and sign written consent. During this visit, the CHW assesses the participant's history with diabetes, medication adherence, self-management activities, healthcare utilization and will administer a finger stick blood test for HbA1c and a full lipid panel. After enrollment, the participant receives up to five follow-up educational visits 0.5, 1.5, 3.5, 7 and 10 months later. In addition to scheduled visits, the CHWs work with their participants on an as-needed basis via telephone, or additional home visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 2 Diabetes