Changing the Healthcare Delivery Model

Completed · Not applicable

Conditions studied: Diabetes Type 2

In brief

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.

Key facts

Study ID

NCT02093234

Run by

George Washington University

People needed

166

Starts

2014-04-01

Expected to finish

2016-08-01

Last updated by the study team

2017-04-06

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Medical Faculty Assoc Inc, GWUniv — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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