Ankylosing SpondylitisNCT00722514
Evaluation of a Patient Education Program for Ankylosing Spondylitis
A study testing patient education in people with Ankylosing Spondylitis and Spondyloarthritis, run by Rehazentrum Bad Eilsen at 1 site in Germany.
Trial summary
Long term disease management is essential for Ankylosing Spondylitis (AS), a chronic progressive systemic inflammatory disease of the axial skeleton. Extensive information about the disease is a necessary first step. An education program for AS was implemented to improve inpatient medical rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Spondyloarthritis
- What is being tested?
- patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jul 1998to Jul 2001
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankylosing Spondylitis (AS) according to modified New York Criteria
- Early diagnosis criteria for AS
- ESSG Criteria for Spondyloarthritis
Who cannot join
- History of malignant disease during past five years
- Secondary fibromyalgia syndrome
- Group integration deficiencies
- Seminar repeaters
Trial locations and contacts
1 site in 1 country.
About this study
Long term disease management is essential for Ankylosing Spondylitis (AS), a chronic progressive systemic inflammatory disease of the axial skeleton. Extensive information about the disease is a necessary first step. An education program for AS was implemented to improve inpatient medical rehabilitation. In a controlled quasi-experimental multicentric study the efficacy of this program was analysed.
- Conditions
- Ankylosing Spondylitis, Spondyloarthritis
- Being tested
- patient education, Standard Care
- Medical subject headings
- Spondylitis, Ankylosing, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient educationBehavioural
- complex individual antiinflammatory rehabilitation program during inpatient rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally
- Patient education 6 x 90 Minutes
Standard CareBehavioural
- complex individual antiinflammatory rehabilitation program during inpatient
- complex individual medical rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally
- further 6 treatments from available disciplines(e.g. massage, electrotherapy, bath)
| Study group | Role | What they receive |
|---|---|---|
| IG | Experimental | Patient education Receives: Behavioral: patient education |
| CG | Other | without patient education Receives: Behavioral: Standard Care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startJul 1998
- Primary completionFeb 2001
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
Sponsor and investigators
- Lead sponsor
- Rehazentrum Bad Eilsen
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Investigators
- Inge Ehlebracht-Koenig, MD, Principal investigator, Rehazentrum Bad Eilsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722514
- Sponsor's protocol ID
- 0110599604
- Status last verified
- Jul 2008
- First submitted
- 23 Jul 2008
- Last updated
- 18 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Patient Education Program for Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00722514
- Acronym / sponsor ID
- 0110599604
- Conditions
- Ankylosing Spondylitis, Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rehazentrum Bad EilsenUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Jul 1998
- Primary completion
- Feb 2001
- Study completion
- Jul 2001
- First posted
- 25 Jul 2008 (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.
Long term disease management is essential for Ankylosing Spondylitis (AS), a chronic progressive systemic inflammatory disease of the axial skeleton. Extensive information about the disease is a necessary first step. An education program for AS was implemented to improve inpatient medical rehabilitation. In a controlled quasi-experimental multicentric study the efficacy of this program was analysed.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IG | Experimental | Behavioral: patient educationPatient education |
| CG | Other | Behavioral: Standard Carewithout patient education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ankylosing Spondylitis (AS) according to modified New York Criteria
- Early diagnosis criteria for AS
- ESSG Criteria for Spondyloarthritis
Key exclusion criteria (4 listed)
- History of malignant disease during past five years
- Secondary fibromyalgia syndrome
- Group integration deficiencies
- Seminar repeaters
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 education* complex individual antiinflammatory rehabilitation program during inpatient rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally * Patient education 6 x 90 Minutes | Behavioural | IG |
| Standard Care* complex individual antiinflammatory rehabilitation program during inpatient * complex individual medical rehabilitation (physiotherapy, physical therapy, occupational therapy, health-promoting measures and more) and additionally * further 6 treatments from available disciplines(e.g. massage, electrotherapy, bath) | Behavioural | CG |
Primary outcome
Not reported in the source record.
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 18 Aug 2008.
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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.
Inge Ehlebracht-Koenig, MD principal investigator
Rehazentrum Bad Eilsen
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 education in people with Ankylosing Spondylitis and Spondyloarthritis, run by Rehazentrum Bad Eilsen 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 3 inclusion and 4 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 18 Aug 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.
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 18 Aug 2008.