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

NCT00525811 | Completed DMC

• 1 other identifier: TK-2005-0111
• Study Type: interventional
• Target: 741
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Low Back Pain; Depression

Outcome Measures

Primary Outcomes (1)

• Decisional conflict

  After using the decision aid

Secondary Outcomes (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

Study Arms (2)

A

EXPERIMENTAL

Interactive decision aid

Other: patient dialogue

B

ACTIVE COMPARATOR

Regular patient information

Other: patient information

Interventions

patient dialogue OTHER

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

A

patient information OTHER

Information on acute low back pain, information on depression

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• insurance members with acute low back pain or depression

You may not qualify if:

• insurance members without symptoms, with chronic back pain, with a bipolar disorder, relatives of people with symptoms

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University Medical Center

Freiburg im Breisgau, 79104, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depression

Interventions

Confidentiality

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Forensic Psychiatry; Psychiatry; Behavioral Sciences; Behavioral Disciplines and Activities; Patient Rights; Human Rights; Social Control, Formal; Health Care Economics and Organizations; Jurisprudence

Study Officials

• Martin Haerter, MD, PhD

  University Medical Center, Freiburg, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 6, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 24, 2008

Record last verified: 2008-06

Locations

DE (1)