Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Low Back Pain Depression |
Other: patient dialogue Other: patient information |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
- Decisional conflict [ Time Frame: After using the decision aid ]
- Knowledge, Preparation for decision making, Preference for participation, Involvement in decision making, Decision regret, Treatment adherence [ Time Frame: After using the decision aid and 3 months later respectively ]
| Enrollment: | 741 |
| Study Start Date: | June 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Interactive decision aid
|
Other: patient dialogue
Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression
|
|
Active Comparator: B
Regular patient information
|
Other: patient information
Information on acute low back pain, information on depression
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Prof. Dr. Dr. Martin Haerter, University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00525811 History of Changes |
| Other Study ID Numbers: | TK-2005-0111 |
| Study First Received: | September 5, 2007 |
| Last Updated: | June 23, 2008 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Back Pain Depression Depressive Disorder Low Back Pain Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013