Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
研究概览
简要总结
Our study intends to test the efficacy of pharmacist-led group interventions on a weekly basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure.
详细描述
Our project intends to study the 6-month efficacy of a pharmacist-led group intervention program that simultaneously target diabetes, hypertension and dyslipidemia. We hypothesize that pharmacist-led group interventions on a weekly basis for 4-weeks then on a monthly basis for 5 additional months may achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure. We are proposing a pilot randomized controlled study to test the efficacy and feasibility of this approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus,
- •>18 years old,
- •with a documented HbA1c more than 7.0%,
- •an LDL cholesterol >100 mg/dl AND a blood pressure >130/80 mm Hg documented at least once in the medical records within the last 6 months, and
- •willing to comply with the study interventions will be eligible for the study.
排除标准
- •pregnancy,
- •unable to attend the group sessions,
- •disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing diabetes self-care,
- •enrolled in the Providence VAMC's Telehealth program
结局指标
主要结局
Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
时间窗: 6 months
Hemoglobin A1C target was \< 7% LDL cholesterol goal of \< 100mg/dl or \<70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of \<130mm Hg
次要结局
未报告次要终点
研究者
Wen-Chih Wu
Staff Cardiologist
Providence VA Medical Center