Changing the Healthcare Delivery Model
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors
      and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell
      phone disease management system plus a community health worker (CHW) is superior to either a
      cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of
      7 Wellness Behaviors and 6 Clinical Goals.
    

Detailed description: 
      This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors
      and clinical goals for DM2 Medicaid patients with uncontrolled DM.

        -  Group 1 will be assisted by the Voxiva Care4Life mobile health disease management
           program (C4L) provided on the patient's cell phone.

        -  Group 2 will be assisted by CHWs who are members of the outpatient medical home health
           team.

        -  Group 3 will be assisted by both the Voxiva Care4Life mHealth disease management system
           (C4L) and a CHW.

      Hypotheses:

        1. A patient interactive cell phone disease management system plus a community health
           worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2
           Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals.

        2. A patient interactive cell phone disease management system will activate Medicaid
           patients with type 2 diabetes (DM2) to improve the composite of 7 wellness behaviors and
           6 clinical outcomes by 25% or greater compared to baseline

      Expected Outcomes:

      Primary outcomes:

        1. Superior improvement over baseline of the composite of Wellness Behaviors and Clinical
           Outcomes in the CHW plus C4L group compared to the CHW alone and cell phone alone
           groups.

        2. Improvement by 25% or greater over baseline of the composite of Wellness Behaviors and
           Clinical Outcomes for patients using C4L alone.

      Secondary outcomes:

      Improvement in both clinical and behavior endpoints. Endpoints to be compared across the
      three treatment arms include:

        1. mean HbA1c,

        2. mean LDLc Cholesterol

        3. average BP if hypertensive

        4. Patient distress measured with Fisher Brief Diabetes Distress Screening Instrument

      4) Medication adherence measured with Morisky Medication Adherence Survey 5) Healthcare
      utilization: ER, acute clinic visits, hospitalizations

      Anticipated results and impact on healthcare:

      Mobile health has great potential to enhance DM2 patient health behaviors and clinical
      outcomes both alone and, even better, with assistance of a CHW. mHealth systems can be
      provided to a wide range of urban and rural DM2 patients resulting in an affordable, a more
      efficient patient-driven/centered health delivery system.
    

Intervention name(s): mobile health care application; CHWs and mobile health care application; Community Health Worker (CHW)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): mobile health application for cell phones to assist patients in managing their diabetes.; CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.; CHWs assist patients in managing their diabetes in various ways.
Other intervention name(s): Care 4 Life; Care 4 Life and patient navigators; Patient navigators
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: self care of diabetes type 2 patients; mobile health cell phone application impact on health; community health workers impact on health