Back to resultsDevelopment of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
Primary Purpose
Acute Low Back Pain, Depression
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
patient dialogue
patient information
Sponsored by
About this trial
This is an interventional health services research trial for Acute Low Back Pain
Eligibility 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
Sites / Locations
- University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Interactive decision aid
Regular patient information
Outcomes
Primary Outcome Measures
Decisional conflict
Secondary Outcome Measures
Knowledge, Preparation for decision making, Preference for participation, Involvement in decision making, Decision regret, Treatment adherence
Full Information
NCT ID
NCT00525811
First Posted
September 5, 2007
Last Updated
June 23, 2008
Sponsor
University Hospital Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT00525811
Brief Title
Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Freiburg
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain, Depression
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
741 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Interactive decision aid
Arm Title
B
Arm Type
Active Comparator
Arm Description
Regular patient information
Intervention Type
Other
Intervention Name(s)
patient dialogue
Intervention Description
Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression
Intervention Type
Other
Intervention Name(s)
patient information
Intervention Description
Information on acute low back pain, information on depression
Primary Outcome Measure Information:
Title
Decisional conflict
Time Frame
After using the decision aid
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Haerter, MD, PhD
Organizational Affiliation
University Medical Center, Freiburg, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
University Medical Center
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.shared-decision-making.org
Description
Related Info
Learn more about this trial
Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
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