Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525811
• Other study ID #: TK-2005-0111
• Status: Completed
• Phase: N/A
• First received: September 5, 2007
• Last updated: June 23, 2008
• Start date: June 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: May 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Low Back Pain
• Back Pain
• Depression
• Low Back Pain

Intervention

Other:
• patient dialogue
Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression
• patient information
Information on acute low back pain, information on depression

Locations

Country	Name	City	State
Germany	University Medical Center	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict		After using the decision aid
Secondary	Knowledge, Preparation for decision making, Preference for participation, Involvement in decision making, Decision regret, Treatment adherence		After using the decision aid and 3 months later respectively

External Links

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