N/A
N=166
Changing the Healthcare Delivery Model
Diabetes Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02093234 ↗Enrolled (actual)
166
Serious AEs
—
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1 — -1.5; -1.7; -1.1 incomplete behaviors/goals — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mobile health care application (Behavioral); CHWs and mobile health care application (Behavioral); Community Health Worker (CHW) (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- George Washington University
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1 |
-1.5; -1.7; -1.1 | <0.0001 sig |
| SECONDARY Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument |
-3.5; -3.7; -4.4 | <0.0001 sig |
| SECONDARY Change in Hemoglobin A1C |
-1.3; -1.2; -1.2 | <0.0001 sig |
| SECONDARY Change in Medication Adherence |
0.4; 0.09; 0.3 | 0.02 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02093234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.