Changing the Healthcare Delivery Model:A Community Health Worker/Mobile Chronic Care Team Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1
时间窗: baseline and 1 year
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.
次要结局
- Change in Hemoglobin A1C(Baseline and 1 year)
- Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument(Baseline and 1 year)
- Change in Medication Adherence(baseline and 1 year)