Acute Low Back PainNCT00525811
Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
A study testing patient dialogue and patient information in people with Acute Low Back Pain and Depression, run by University Hospital Freiburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Low Back Pain, Depression
- What is being tested?
- patient dialogue and patient information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 741 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- insurance members with acute low back pain or depression
Who cannot join
- insurance members without symptoms, with chronic back pain, with a bipolar disorder, relatives of people with symptoms
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- patient dialogue, patient information
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient dialogueOther
Information on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression
patient informationOther
Information on acute low back pain, information on depression
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Interactive decision aid Receives: Other: patient dialogue |
| B | Active comparator | Regular patient information Receives: Other: patient information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
Measured: After using the decision aid
Secondary outcomes (1)
Knowledge, Preparation for decision making, Preference for participation, Involvement in decision making, Decision regret, Treatment adherence
Measured: After using the decision aid and 3 months later respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Martin Haerter, MD, PhD, Study chair, University Medical Center, Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525811
- Sponsor's protocol ID
- TK-2005-0111
- Status last verified
- Jun 2008
- First submitted
- 5 Sep 2007
- Last updated
- 24 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression
- ClinicalTrials.gov ID
- NCT00525811
- Acronym / sponsor ID
- TK-2005-0111
- Conditions
- Acute Low Back Pain, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: patient dialogueInteractive decision aid |
| B | Active comparator | Other: patient informationRegular patient information |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- insurance members with acute low back pain or depression
Key exclusion criteria (1 listed)
- insurance members without symptoms, with chronic back pain, with a bipolar disorder, relatives of people with symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient dialogueInformation on shared decision making, how to participate in medical decision making, information on acute low back pain, information on depression | Other | A |
| patient informationInformation on acute low back pain, information on depression | Other | B |
Primary outcome
Decisional conflict
Time frame: After using the decision aid
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2008.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Haerter, MD, PhD study chair
University Medical Center, Freiburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient dialogue and patient information in people with Acute Low Back Pain and Depression, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: After using the decision aid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2008.