NCT01861756已完成不适用
The Diabetes Medication Choice Cards Trial in Greece
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 8
- 主要终点
- Overall Decisional Comfort (0-100, 100=no Conflict)
研究概览
简要总结
A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus for more than one year
- •Agree to be followed for at least 6 months
- •Willing to respond to survey questions immediately following the visit
- •HbA1c value between 7.5% and 10%
- •Need treatment intensification and there are more than one available treatment options
排除标准
- •Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment
- •Is to transfer to another practice within the next 6 months
- •Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid
- •Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge
- •Enrolled in other studies that require prolonged participation and follow-up
- •Unable to speak Greek at a level necessary to complete the patient surveys and ensure involvement in decision making
- •Women known to be pregnant
结局指标
主要结局
Overall Decisional Comfort (0-100, 100=no Conflict)
时间窗: Day 1
Quality of the decision making process assessed by means of the Decisional Conflict Scale
次要结局
- Glycemic Control (HbA1c)(3 and 6 months after patient initial encounter)
- Patient and Clinician Satisfaction With the Decision Making Process(Day 1)
- Degree of Patient Knowledge About Available Treatment Alternatives(Day 1)
- Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records(3 and 6 months after patient initial encounter)
研究者
Apostolos Tsapas
Assistant Professor of Medicine
Aristotle University Of Thessaloniki
研究点 (8)
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