Changing the Healthcare Delivery Model — C4H  

Diabetes Type 2 Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. % 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

• NCT number: NCT02093234
• Study type: Interventional
• Source: George Washington University
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2014
• Completion date: September 2016