Clinical trial NCT02093234: Changing the Healthcare Delivery Model
Official title: Changing the Healthcare Delivery Model:A Community Health Worker/Mobile Chronic Care Team Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Keywords: self care of diabetes type 2 patients
mobile health cell phone application impact on health
community health workers impact on health
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 166
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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. mean HbA1c,
2. mean LDLc Cholesterol
3. average BP if hypertensive
4. Patient distress measured with Fisher Brief Diabetes Distress Screening Instrument

4) Medication adherence measured with Morisky Medication Adherence Survey 5) Healthcare utilization: ER, acute clinic visits, hospitalizations

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.

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

Primary outcomes:
measure: Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1
timeFrame: baseline and 1 year
Secondary outcomes:
measure: Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument
timeFrame: Baseline and 1 year
measure: Change in Hemoglobin A1C
timeFrame: Baseline and 1 year
measure: Change in Medication Adherence
timeFrame: baseline and 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medical Faculty Assoc Inc, GWUniv
state: District of Columbia
Study officials:
affiliation: Medical Faculty Assoc. Inc, GWUniv
name: Richard Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: