Diabetes Self-Management Models to Reduce Health Disparities
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PDA; CDSMP; PDA/CDSMP
Intervention description: Technological assistance; 6-week classes; Combined technology and education
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 2 diabetes; Health disparities; Central Texas; PDA; CDSMP

Summary:

      To evaluate the effectiveness of two different diabetes self-management approaches (Personal
      Digital Assistant-based intervention & Chronic Disease Self-Management Program) to reduce
      health disparities in minority, rural residents, and other underserved populations with type
      2 diabetes in Central Texas. We hypothesise that: 1) Racial/ethnic minority patients with
      T2DM will be found to experience disparities in diabetes self-management treatment protocols
      and clinical outcomes, which persist even when controlling for age, gender, obesity, and
      insurance status; 2) Patients with T2DM who reside in more rural areas will be found to
      experience disparities in diabetes self-management treatment protocols and clinical outcomes
      as compared to more urban counterparts, controlling for age, gender, race/ethnicity, obesity,
      and insurance status; 3) The introduction of CSDMP and HIT protocols will improve
      diabetes-related self management behaviors, reduce HBA1c values, and increase quality of life
      in persons with T2DM as compared to controls. A combined intervention approach will result in
      the greatest reductions; 4) Health improvements following the introduction of CDSMP, HIT or
      CDSMP/HIT protocols in persons with T2DM compared to controls will be more marked in
      racial/ethnic minority patients and those patients residing in rural areas; 5) The
      introduction of self-management interventions will be cost-effective in reducing HbA1c values
      over time, and associated health care utilization including overall reduction in ER and acute
      care hospital admissions; 6) Although there is little prior research in this area to guide
      specific hypotheses, we hypothesize that, overall, there will be no significant
      cost-effective differential in CDSMP as compared to HIT approaches, although the
      cost-effective ratio may be stronger in particular subpopulations. The combined approach will
      have higher costs, but is also anticipated to have a higher cost-benefit ratio for minority
      populations; 7) The majority of clinicians will be willing to let their patients enroll in
      the study and will reinforce intervention protocols; and 8) These interventions can be
      embedded into existing health care structures. At the end of the study, Scott and White will
      institutionalize cost-effective treatment protocols.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM, including those who require insulin therapy, aged >18 years
             (eliminates the need to obtain assent for minors who are also dependent on their
             parents).

          -  Last measured HbA1c value of > 7.5% (this study hopes to show an improvement in the
             control of patient's diabetes, and not focused on patients who already show evidence
             of good disease control).

          -  Willingness and ability to attend one initial research visit and semi-annual routine
             follow-up visits over a 24-month period. The follow-up visits include height, weight,
             and blood pressure measurement and a survey. Surveys may be conducted by phone
             interview or mail when a follow-up visit can not be scheduled.

          -  Ability to read, write, and speak English at least at a grade 8 level so as to be able
             to engage in self-monitoring and use the commercial diabetes management software
             program (Diabetes Pilot), which is available only in English. For those with
             lower-literacy, assistance in filling out forms and understanding required
             intervention protocols will be provided, and use of a "buddy" will be recommended.

        Exclusion Criteria:

          -  Not willing to sign an informed consent or be randomized to any of the four
             treatment/control groups, (we want to minimize any upfront treatment biases, while
             adhering to human subject protocols).

          -  Currently, documented severe alcoholism or drug abuse that is < 6 months ago (concerns
             that this problem is likely to significantly affect their ability and likelihood to
             comply with the study requirements over the course of the 24 months).

          -  Female patients who are pregnant or planning to become pregnant within 12 months (in
             pregnancy, type 2 diabetes is managed in a completely different manner than in
             non-pregnant patients).