Changing the Healthcare Delivery Model
C4H
2 other identifiers
interventional
166
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 20, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
April 6, 2017
CompletedApril 6, 2017
September 1, 2016
2.3 years
March 17, 2014
December 29, 2016
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1
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 mean change after 1 year in number of behaviors/goals met from baseline.
baseline and 1 year
Secondary Outcomes (3)
Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument
Baseline and 1 year
Change in Hemoglobin A1C
Baseline and 1 year
Change in Medication Adherence
baseline and 1 year
Study Arms (3)
Mobile health care application
ACTIVE COMPARATORPatients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.
Community Health Worker (CHW)
ACTIVE COMPARATORCHWs assist study patients in managing there health care in various ways.
CHWs and mobile health care application
EXPERIMENTALPatients will receive assistance in managing their health from both CHWs and the mobile health cell phone application
Interventions
mobile health application for cell phones to assist patients in managing their diabetes.
CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.
CHWs assist patients in managing their diabetes in various ways.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Faculty Assoc Inc, GWUniv
Washington D.C., District of Columbia, 20037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Katz, MD
- Organization
- GW Medical Faculty Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Katz, MD
Medical Faculty Assoc. Inc, GWUniv
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2014
First Posted
March 20, 2014
Study Start
April 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
April 6, 2017
Results First Posted
April 6, 2017
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
De-identified participant data for all primary and secondary outcomes measures will be made available with 6 months of study completion