Effectiveness of a High-risk Diabetic Patients Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin
研究概览
简要总结
The purpose of this study is to determine whether case management for type 2 diabetic patients with target-organ damage improves quality of care compared to usual care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes mellitus
- •Age between 18 and 80 years old
- •Target organ damage (either macrovascular or microvascular)
- •Patient's acceptance to participate
排除标准
- •Moderate to severe dementia
- •Life expectancy lower than one year
- •Justified negative from primary care physician to intervene the patient.
研究组 & 干预措施
Case management
Patients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets.
干预措施: Case manager counseling (Behavioral)
Usual care group
Usual care provided by primary care physician and/or specialist. Free access to diabetes educational workshops. Regular delivery of educational brochures (not personally targeted).
干预措施: Usual care (Other)
结局指标
主要结局
Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin
时间窗: Two years
次要结局
- Quality of care process measures(Two years)
研究者
Gaston Perman
Head of Medical Programs
Hospital Italiano de Buenos Aires