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Clinical Trials/NCT00525811
NCT00525811CompletedNot Applicable

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

University Hospital Freiburg2 sites in 1 country741 target enrollmentStarted: June 1, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
741
Locations
2
Primary Endpoint
Decisional conflict

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
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

Outcomes

Primary Outcomes

Decisional conflict

Time Frame: After using the decision aid

Secondary Outcomes

  • 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)

Investigators

Sponsor
University Hospital Freiburg
Sponsor Class
Other

Study Sites (2)

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