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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00525811
First Posted: September 6, 2007
Last Update Posted: June 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Freiburg
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Decisional conflict [ Time Frame: After using the decision aid ]

Secondary Outcome Measures:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525811


Locations
Germany
University Medical Center
Freiburg, Germany, 79104
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Study Chair: Martin Haerter, MD, PhD University Medical Center, Freiburg, Germany
  More Information

Additional Information:
Responsible Party: Prof. Dr. Dr. Martin Haerter, University Medical Center
ClinicalTrials.gov Identifier: NCT00525811     History of Changes
Other Study ID Numbers: TK-2005-0111
First Submitted: September 5, 2007
First Posted: September 6, 2007
Last Update Posted: June 24, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Depression
Depressive Disorder
Back Pain
Low Back Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms