Validation of a Patient Decision Aid for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Knowledge score
研究概览
简要总结
The objectives of this study are to compare measurements in knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among two groups of type 2 diabetes patients, those who receive a Patient Decision Aid and those who receive usual care.
详细描述
This study uses a randomized, controlled trial design to compare knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among patients with uncontrolled type 2 diabetes who are only taking metformin medication. The intervention is a Patient Decision Aid (PDA) video delivered via the internet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18 or older
- •English speaking
- •Currently taking metformin
- •Inadequate glycemic control in the opinion of the investigator
- •Is considering additional medication options on the advice of their physician
- •Can provide a valid email address
- •Access to the internet and able to read and respond to internet questionnaires
排除标准
- •Participation in a clinical trial of a diabetes medication within 1 year
- •Currently taking more than two (2) medications for diabetes
- •Has been exposed to diabetes medications from more than three (3) drug classes
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
结局指标
主要结局
Knowledge score
时间窗: 6 weeks
The primary endpoint for this investigation is the knowledge total score at final followup 4- 6 weeks after randomization between the PDA versus usual care groups. Questions are about available treatments and specific to the information on medication options available to people with type 2 diabetes when metformin alone does not achieve adequate glycemic control.
次要结局
- Decisional conflict(6 weeks)
研究者
Alicia Shillington
Executive Vice President
EPI-Q