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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00525811
Enrollment
741
Registered
2007-09-06
Start date
2007-06-30
Completion date
2008-05-31
Last updated
2008-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Low Back Pain, Depression

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.

Interventions

OTHERpatient dialogue

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

Information on acute low back pain, information on depression

Sponsors

University Hospital Freiburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Decisional conflictAfter using the decision aid

Secondary

MeasureTime frame
Knowledge, Preparation for decision making, Preference for participation, Involvement in decision making, Decision regret, Treatment adherenceAfter using the decision aid and 3 months later respectively

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026