Changing the Healthcare Delivery Model (C4H)

George Washington University (GW)

Status: Completed

Conditions: Diabetes Type 2

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02093234

IH-1304-6797 (Other Grant/Funding Number)

PCORI- IH-1304-6797

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 3 patient groups

Mobile health care application

Active Comparator group

Description:

Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.

Treatment:

Behavioral: mobile health care application

Community Health Worker (CHW)

Active Comparator group

Description:

CHWs assist study patients in managing there health care in various ways.

Treatment:

Behavioral: Community Health Worker (CHW)

CHWs and mobile health care application

Experimental group

Description:

Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application

Treatment:

Behavioral: CHWs and mobile health care application