Changing the Healthcare Delivery Model

NCT ID: NCT02093234

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-08-31

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.

Conditions

Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

mobile health care application

Intervention Type: BEHAVIORAL

mobile health application for cell phones to assist patients in managing their diabetes.

Community Health Worker (CHW)

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

Group Type: ACTIVE_COMPARATOR

Community Health Worker (CHW)

Intervention Type: BEHAVIORAL

CHWs assist patients in managing their diabetes in various ways.

CHWs and mobile health care application

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

Group Type: EXPERIMENTAL

CHWs and mobile health care application

Intervention Type: BEHAVIORAL

CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.

Interventions

mobile health care application

mobile health application for cell phones to assist patients in managing their diabetes.

Intervention Type: BEHAVIORAL

CHWs and mobile health care application

CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.

Intervention Type: BEHAVIORAL

Community Health Worker (CHW)

CHWs assist patients in managing their diabetes in various ways.

Intervention Type: BEHAVIORAL

Other Intervention Names

Care 4 Life; Care 4 Life and patient navigators; Patient navigators

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty Assoc. Inc, GWUniv

Locations

Medical Faculty Assoc Inc, GWUniv

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

IH-1304-6797

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PCORI- IH-1304-6797

Identifier Type: -

Identifier Source: org_study_id