Overview

This trial is active, not recruiting.

Condition diabetes type 2
Treatments mobile health care application, chws and mobile health care application, community health worker (chw)
Sponsor George Washington University
Start date April 2014
End date August 2016
Trial size 200 participants
Trial identifier NCT02093234, IH-1304-6797, PCORI- IH-1304-6797

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
mobile health care application Care 4 Life
mobile health application for cell phones to assist patients in managing their diabetes.
(Active Comparator)
CHWs assist study patients in managing there health care in various ways.
community health worker (chw) Patient navigators
CHWs assist patients in managing their diabetes in various ways.
(Experimental)
Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
chws and mobile health care application Care 4 Life and patient navigators
CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.

Primary Outcomes

Measure
The percentage of the 13 goals/behaviors met by each of the 3 groups.
time frame: 1 year

Secondary Outcomes

Measure
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year
Improvement in both behavior and clinical endpoints
time frame: 1 year

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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

Additional Information

Official title Changing the Healthcare Delivery Model:A Community Health Worker/Mobile Chronic Care Team Strategy
Principal investigator Richard Katz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by George Washington University.