Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
Shared decision making (SDM) has been advocated as an appropriate approach for physician patient communication. Positive effects of SDM are e.g higher patient satisfaction, greater treatment adherence, lower decisional conflict and better clinical outcomes. The Section of Clinical Epidemiology and Health Services Research at the University Medical Center in Freiburg (Germany) is developing and evaluating a web-based interactive decision aid ("patient dialogue") to support shared decision making in cooperation with the Techniker Krankenkasse, a large German health insurance company. Both development and evaluation are conducted along the International Patient Decision Aid Standards (IPDAS).
The decision aid contains information on acute low back pain and depression and addresses insurance members who are facing a treatment decision in one of the indications. It aims at the development of patient competencies for participating in decision making, the support of constructive health behavior and patients' acceptance of evidence based treatment options.
In an RCT the decision aid will be compared to a regular patient information on a sample of N=500 patients in each group. Data collection will take place at three points of time: before and after use of the decision aid as well as 3 months later.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Freiburg、德国、79104
- University Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- insurance members with acute low back pain or depression
Exclusion Criteria:
- insurance members without symptoms, with chronic back pain, with a bipolar disorder, relatives of people with symptoms
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:A
Interactive decision aid
|
Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression
|
|
有源比较器:B
Regular patient information
|
Information on acute low back pain, information on depression
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Decisional conflict
大体时间:After using the decision aid
|
After using the decision aid
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Knowledge, Preparation for decision making, Preference for participation, Involvement in decision making, Decision regret, Treatment adherence
大体时间:After using the decision aid and 3 months later respectively
|
After using the decision aid and 3 months later respectively
|
合作者和调查者
调查人员
- 学习椅:Martin Haerter, MD, PhD、University Medical Center, Freiburg, Germany
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.