Changing the Healthcare Delivery Model

Diabetes Type 2 Clinical Trial

— C4H  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02093234
• Other study ID #: PCORI- IH-1304-6797
• Secondary ID: IH-1304-6797
• Status: Active, not recruiting
• Phase: N/A
• First received: March 17, 2014
• Last updated: February 8, 2016
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2016
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
United States	Howard University	Washington	District of Columbia
United States	Medical Faculty Assoc Inc, GWUniv	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of the 13 goals/behaviors met by each of the 3 groups.	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 % of patients that have achieved >10 of the 13 wellness behaviors if patient is hypertensive ,or > 9 of the 13 wellness behaviors if patient is not hypertensive and clinical goals met at 1 year compared to baseline.	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms include: 1) Healthcare Effectiveness Data Information Set	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	to be compared across the tree treatment arms: 2) mean Hemoglobin A1C	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms 3) Average B/P	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms: 4) Number of emergency room visits	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms: 5) number of hospitalizations	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms: 6) number of unscheduled acute care clinic visits	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms: 7) number of target medication adjustments	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms: 8) Frequency of self care activities ( diet, exercise, blood glucose and blood pressure testing)	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms: 9) Patient utilization of and satisfaction with the support provided by the Voxiva system cell phone system alone, the CHWs alone and the combined CHW /Voxiva care model.	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms: 10) Medication adherence	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms: 11) Healthcare team utilization of and satisfaction with the Voxiva system alone, the CHW alone, and the combined CHW/Voxiva care model	1 year	No
Secondary	Improvement in both behavior and clinical endpoints	Endpoints to be compared across the three treatment arms responses to behavioral questionnaires	1 year	No