Phase 3 Randomized Controlled Trial of the Diabetes Health Enhancement Program for Medicaid and Dual Eligibles in South King County, Washington
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Reduction in glycated hemoglobin levels
研究概览
简要总结
Management of chronic diseases, such as diabetes, relies upon the health care providers and the patients self-care. Self management programs for diabetes that target self-empowerment tools have been found to be effective in some studies, but have not typically included individuals on Medicaid.
Our goal for this trial was to observe if patients participating in such a program could decrease glycated hemoglobin levels, improve health status and improve self-care practices.
详细描述
Design, Setting and Population: A Phase 3, one year prospective trial, randomized to intervention or control (usual care) with Medicaid or dual-Medicare beneficiaries, with diabetes, aged 40-85 years old residing in South King County, Washington.
Intervention: A targeted, multi-component, self-management program incorporating a stage-of-change approach to overcome barriers and facilitate life-style behavior changes to achieve patient-driven health action plans for nutrition or exercise goals.
Main Outcome Measures: Glycemic control (HbA1c), physical and mental health, self-care practices.
Recruitment Status: Completed: participants are no longer being recruited; data analysis is complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Educational Counseling Training
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insured under Medicaid (SSI) or dual enrolled under Medicaid and Medicare for at least one year
- •Diagnosed type 1 or type 2 diabetes for at least 1 year (>1 inpatient or >2 outpatients visits with ICD-9 codes 250.00-250.9x, or prescriptions for insulin and/or oral hyperglycemic medications)
- •Aged 40-85 years
- •Geographically close to the Southeast Senior Center in South King County, Washington, and have a primary care provider (not HMO).
排除标准
- •Serious kidney disease (serum creatinine >2.5 or end-stage renal disease)
- •Other serious illness that would preclude one-year study participation (dementia, terminal illness, organ transplantation)
- •Pregnancy
- •Inability to given informed consent.
结局指标
主要结局
Reduction in glycated hemoglobin levels
次要结局
- Improvement in health status and diabetes self-care practices