NCT02093234

Changing the Healthcare Delivery Model

Changing the Healthcare Delivery Model:A Community Health Worker/Mobile Chronic Care Team Strategy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	mobile health care application	mobile health application for cell phones to assist patients in managing their diabetes.
BEHAVIORAL	CHWs and mobile health care application	CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.
BEHAVIORAL	Community Health Worker (CHW)	CHWs assist patients in managing their diabetes in various ways.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-03-20
• Last updated: 2017-04-06
• Results posted: 2017-04-06

Locations

1 site across 1 country: United States