Changing the Healthcare Delivery Model

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. % patients meeting the modified HEDIS1 goals,

2. mean A1c,

3. average BP if hypertensive

4. emergency room visits

5. hospitalizations

6. unscheduled acute care clinic visits

7. # of target medication adjustments,

8. patient level of self activation in the management of DM2 (PAM-13 questionnaire),

9. patient utilization of and satisfaction with the support provided by CHWs alone, C4L
alone and the combined CHW/C4L approach,

10. medication adherence,

11. healthcare team utilization of and satisfaction with the CHW alone versus the Voxiva
system alone versus the combined CHW/C4L care model.

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.

Inclusion Criteria:

- Age 21 to 75 years old

- Medicaid insurance coverage, Medicare insurance coverage or Affordable Health Care
Act insurance coverage

- Fluent in English or Spanish and able to read a text message

- Diagnosed with diabetes mellitus type 2 and A1C is > 8%

Acceptable values will be either :

- A1c obtained within one month prior to baseline (as long as there were no diabetes
changes made during that month) or

- A new A1c measured at the baseline screening visit.

- Meets < 10 of the wellness behaviors and clinical goals if diagnosed with
hypertension Meets < 9 of the wellness behaviors and clinical goals if not diagnosed
with hypertension

Exclusion Criteria:

- Stage 5 chronic kidney disease or end stage renal disease on dialysis

- Terminal illness (expected survival of less than one year)

- Severe dementia or uncontrolled mental illness

- Gestational diabetes mellitus

- Use of an insulin pump

- Inability to use a cellular phone

- Unable to use software application on cellular phone

- Pregnant or planning to get pregnant