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OpenTrials
Completed

NCT Number: NCT00525811

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center

Freiburg im Breisgau, 79104, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient dialogue

Other

Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression

Patient information

Other

Information on acute low back pain, information on depression

Primary outcomes

  1. Decisional conflict

    Time frame: After using the decision aid

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 6, 2007
Registry last updated
Jun 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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