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

• Sponsor: University Hospital Freiburg (Other)
• Overall Status: Completed
• CT.gov ID: NCT00525811
• Collaborator: (none)
• Enrollment: 741
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 67.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Low Back Pain; Depression	Other: patient dialogue; Other: patient information	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 741 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Decisional conflict [After using the decision aid]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center	Freiburg		Germany	79104

Sponsors and Collaborators

• University Hospital Freiburg

Investigators

• Study Chair: Martin Haerter, MD, PhD, University Medical Center, Freiburg, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00525811
• Other Study ID Numbers: TK-2005-0111
• First Posted: Sep 6, 2007
• Last Update Posted: Jun 24, 2008
• Last Verified: Jun 1, 2008

• Additional relevant MeSH terms: Back Pain; Low Back Pain; Depression; Depressive Disorder

Study Results

No Results Posted as of Jun 24, 2008