Changing the Healthcare Delivery Model

Not Applicable

Completed

Conditions: Diabetes Type 2

Interventions: Behavioral: Community Health Worker (CHW)
Behavioral: mobile health care application
Behavioral: CHWs and mobile health care application

Registration Number: NCT02093234

Lead Sponsor: George Washington University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 166

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Health Worker (CHW)	Community Health Worker (CHW)	CHWs assist study patients in managing there health care in various ways.
Mobile health care application	mobile health care application	Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
CHWs and mobile health care application	CHWs and mobile health care application	Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1	baseline and 1 year	The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1C	Baseline and 1 year	Change in HbA1c after 1 year from baseline
Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument	Baseline and 1 year	Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24. Low distress \< 12 : moderate / high distress \> or = 12.
Change in Medication Adherence	baseline and 1 year	Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent