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

NCT ID: NCT00525811

Last Updated: 2008-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

741 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Low Back Pain Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Interactive decision aid

Group Type EXPERIMENTAL

patient dialogue

Intervention Type OTHER

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

B

Regular patient information

Group Type ACTIVE_COMPARATOR

patient information

Intervention Type OTHER

Information on acute low back pain, information on depression

Interventions

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patient dialogue

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

Intervention Type OTHER

patient information

Information on acute low back pain, information on depression

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Freiburg

OTHER

Sponsor Role lead

Responsible Party

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University Medical Center

Principal Investigators

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Martin Haerter, MD, PhD

Role: STUDY_CHAIR

University Medical Center, Freiburg, Germany

Locations

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University Medical Center

Freiburg im Breisgau, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.shared-decision-making.org

Related Info

Other Identifiers

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TK-2005-0111

Identifier Type: -

Identifier Source: org_study_id