Rheumatoid ArthritisPhase 3NCT00229541
Medical In-Patient Rehabilitation in Rheumatoid Arthritis
A Phase 3 study testing Counselling and 3-week medical in-patient rehabilitation in people with Rheumatoid Arthritis, run by University of Luebeck at 1 site in Germany.
Trial summary
The randomised controlled trial explores the efficacy of a counselling interview on an multidisciplinary multimodal intervention to ameliorate the somatic, mental and social medical progress of rheumatoid arthritis in gainfully employed insurants of compulsory health insurances and statutory pension insurances . Read more about this study
- Who is it for?
- Ages 20 to 62 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Counselling and 3-week medical in-patient rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2003to Mar 2006
- Phase
- Phase 3
- 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 20 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Rheumatoid arthritis / psoriatic arthritis (expert decision, ACR criteria)
- Insurant of co-operating health insurance and pension insurance
- Gainfully employed
- Eligible to receive a medical in-patient rehabilitation
Who cannot join
- Polyarthritis, inflammatory intestinal diseases and diseases of connective tissue
- Currently work disabled
- Not able / not willing to co-operate
- Medical in-patient rehabilitation within past 48 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Social Medicine, University of Luebeck
Lübeck, 23538
About this study
Official title: Medical In-Patient Rehabilitation in Rheumatoid Arthritis: Acceptance and Outcomes in Insurants of Compulsory Health Insurances and Statutory Pension Insurances (VERA)
The randomised controlled trial explores the efficacy of a counselling interview on an multidisciplinary multimodal intervention to ameliorate the somatic, mental and social medical progress of rheumatoid arthritis in gainfully employed insurants of compulsory health insurances and statutory pension insurances . Additionally, the feasibility to recruit a study population via databases of compulsory health insurances is examined.
Read the detailed description
Rheumatoid arthritis is the most prevalent inflammatory rheumatic disease. Limited participation of the individual patient accumulates with large amounts of indirect costs for society: About 40 % of the affected patients have to quit their jobs within the first three to four years after disease onset. Nevertheless, the German health care system still seems to lack an adequate supply, particularly in case of medical rehabilitation in early stages of disease. International clinical trials, reviews amd evidence-based guidelines emphasize the importance of an early multimodal multidisciplinary team care as in Germany provided by specialised clinics through three-week in-patient medical rehabilitation programs. The available study explores the efficacy of a counselling interview on an medical in-patient rehabilitation in a randomised controlled design. Exclusively, gainfully employed insurants of compulsory health insurances and statutory pension insurances are included in the study.
Secondary, to avoid the problem of a selection bias caused by recruitment via clinics or doctors, the RCT tests the possibility to recruit potential participants by data of the co-operating health insurances on RA-specific diagnoses of work incapacity, hospital discharge diagnoses, and medical prescriptions within the past 24 months.
Detailed process:
- Recruitment of a potential study population via health insurance data (defined search criteria: ICD-10 diagnoses M05/06/13/79 in case of work disability/hospital discharge, RA-specific medical prescriptions within the past 24 months)
- screening questionnaire to verify in-/exclusion criteria
- selection of eligible insurants (RA-criteria of American College of Rheumatology, clinical expert)
- baseline measurement (e.g. SF-36, RAQoL, FFbH-P, SPE)
- external stratified block by block randomization: intervention group (3- week medical in-patient rehabilitation) vs. control group (usual care)
- follow-up measurement (12 months after baseline)
- data transfer of health insurances and pension insurances
Comparison:
Looking at a 12-months follow-up, the intervention group (3-week medical in-patient rehabilitation) is expected to show significant enhancement in somatic, mental and social medical parameters concerning rheumatoid arthritis compared to a control group receiving usual care.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Counselling and 3-week medical in-patient rehabilitation
- Keywords
- Medical in-patient rehabilitation, Gainfully employed, Work incapacity
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling and 3-week medical in-patient rehabilitationProcedure or surgery
Counselling and 3-week medical in-patient rehabilitation in IG
| Study group | Role | What they receive |
|---|---|---|
| IG | Experimental | intervention group, receives counselling on medical inpatient rehabilitation by statutory health insurance, is intended to apply for a 3-wek medical inpatient rehabilitation at the co-operating clinic (Bad Bramstedt) Receives: Procedure: Counselling and 3-week medical in-patient rehabilitation |
| KG | No intervention | control group, receives usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
work incapacity (incidence, duration)
Measured: baseline, 12 months follow-up
Secondary outcomes (6)
general health status (SF-36)
Measured: baseline, 12 months follow-up
Functional capacity (FFbH-P)
Measured: baseline, 12 months follow-up
Quality of life (RAQoL)
Measured: baseline
Subjective prognosis of gainful employment (SPE-scale)
Measured: baseline, 12 months follow-up
Somatization (SCL-90-R)
Measured: baseline, 12 months follow-up
Depression
Measured: baseline, 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startOct 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- AOK Schleswig-Holstein, BEK Nord, Draeger and Hanse BKK, DAK Gesundheit, IKK Schleswig-Holstein, TK Schleswig-Holstein, LVA Schleswig-Holstein, BfA, Deutsche Rheumaliga Schleswig-Holstein, Berufsverband Deutscher Rheumatologen
- Investigators
- Heiner Raspe, Prof.Dr.Dr., Principal investigator, Institute for Social Medicine, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229541
- Sponsor's protocol ID
- FKZ 01GL0306
- Status last verified
- Oct 2007
- First submitted
- 27 Sep 2005
- Last updated
- 29 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schlademann S, Huppe A, Raspe H. [Results of a randomised controlled trial on the acceptance and the outcomes of a counselling on medical inpatient rehabilitation in gainfully employed members of statutory health insurances with rheumatoid arthritis (clinicaltrials.gov identifier NCT00229541)]. Gesundheitswesen. 2007 Jun;69(6):325-35. doi: 10.1055/s-2007-982519. German.
PubMed 17642037
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical In-Patient Rehabilitation in Rheumatoid Arthritis: Acceptance and Outcomes in Insurants of Compulsory Health Insurances and Statutory Pension Insurances (VERA)
- ClinicalTrials.gov ID
- NCT00229541
- Acronym / sponsor ID
- FKZ 01GL0306
- Conditions
- Rheumatoid Arthritis
- Keywords
- Medical in-patient rehabilitation, Gainfully employed, Work incapacity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- AOK Schleswig-Holstein, BEK Nord, Draeger and Hanse BKK, DAK Gesundheit, IKK Schleswig-Holstein, TK Schleswig-Holstein, LVA Schleswig-Holstein, BfA, Deutsche Rheumaliga Schleswig-Holstein, Berufsverband Deutscher Rheumatologen
- Study start
- Oct 2003
- Study completion
- Mar 2006 (actual)
- First posted
- 29 Sep 2005 (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.
The randomised controlled trial explores the efficacy of a counselling interview on an multidisciplinary multimodal intervention to ameliorate the somatic, mental and social medical progress of rheumatoid arthritis in gainfully employed insurants of compulsory health insurances and statutory pension insurances . Additionally, the feasibility to recruit a study population via databases of compulsory health insurances is examined.
Detailed description
Rheumatoid arthritis is the most prevalent inflammatory rheumatic disease. Limited participation of the individual patient accumulates with large amounts of indirect costs for society: About 40 % of the affected patients have to quit their jobs within the first three to four years after disease onset. Nevertheless, the German health care system still seems to lack an adequate supply, particularly in case of medical rehabilitation in early stages of disease. International clinical trials, reviews amd evidence-based guidelines emphasize the importance of an early multimodal multidisciplinary team care as in Germany provided by specialised clinics through three-week in-patient medical rehabilitation programs. The available study explores the efficacy of a counselling interview on an medical in-patient rehabilitation in a randomised controlled design. Exclusively, gainfully employed insurants of compulsory health insurances and statutory pension insurances are included in the study.
Secondary, to avoid the problem of a selection bias caused by recruitment via clinics or doctors, the RCT tests the possibility to recruit potential participants by data of the co-operating health insurances on RA-specific diagnoses of work incapacity, hospital discharge diagnoses, and medical prescriptions within the past 24 months.
Detailed process:
- Recruitment of a potential study population via health insurance data (defined search criteria: ICD-10 diagnoses M05/06/13/79 in case of work disability/hospital discharge, RA-specific medical prescriptions within the past 24 months)
- screening questionnaire to verify in-/exclusion criteria
- selection of eligible insurants (RA-criteria of American College of Rheumatology, clinical expert)
- baseline measurement (e.g. SF-36, RAQoL, FFbH-P, SPE)
- external stratified block by block randomization: intervention group (3- week medical in-patient rehabilitation) vs. control group (usual care)
- follow-up measurement (12 months after baseline)
- data transfer of health insurances and pension insurances
Comparison:
Looking at a 12-months follow-up, the intervention group (3-week medical in-patient rehabilitation) is expected to show significant enhancement in somatic, mental and social medical parameters concerning rheumatoid arthritis compared to a control group receiving usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IG | Experimental | Procedure: Counselling and 3-week medical in-patient rehabilitationintervention group, receives counselling on medical inpatient rehabilitation by statutory health insurance, is intended to apply for a 3-wek medical inpatient rehabilitation at the co-operating clinic (Bad Bramstedt) |
| KG | No intervention | –control group, receives usual care |
Who may qualify
- Ages
- 20 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Rheumatoid arthritis / psoriatic arthritis (expert decision, ACR criteria)
- Insurant of co-operating health insurance and pension insurance
- Gainfully employed
- Eligible to receive a medical in-patient rehabilitation
Key exclusion criteria (4 listed)
- Polyarthritis, inflammatory intestinal diseases and diseases of connective tissue
- Currently work disabled
- Not able / not willing to co-operate
- Medical in-patient rehabilitation within past 48 months
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 |
|---|---|---|
| Counselling and 3-week medical in-patient rehabilitationCounselling and 3-week medical in-patient rehabilitation in IG | Procedure or surgery | IG |
Primary outcome
work incapacity (incidence, duration)
Time frame: baseline, 12 months follow-up
6 secondary outcomes
general health status (SF-36)
Time frame: baseline, 12 months follow-up
Functional capacity (FFbH-P)
Time frame: baseline, 12 months follow-up
Quality of life (RAQoL)
Time frame: baseline
Subjective prognosis of gainful employment (SPE-scale)
Time frame: baseline, 12 months follow-up
Somatization (SCL-90-R)
Time frame: baseline, 12 months follow-up
Depression
Time frame: baseline, 12 months follow-up
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 29 Oct 2007.
- Results publication: PubMed 17642037Schlademann S, Huppe A, Raspe H. [Results of a randomised controlled trial on the acceptance and the outcomes of a counselling on medical inpatient rehabilitation in gainfully employed members of statutory health insurances with rheumatoid arthritis (clinicaltrials.gov identifier NCT00229541)]. Gesundheitswesen. 2007 Jun;69(6):325-35. doi: 10.1055/s-2007-982519. German.
- homepage Institute for Social Medicine, University of LuebeckLink 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.
Heiner Raspe, Prof.Dr.Dr. principal investigator
Institute for Social Medicine, University of Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Counselling and 3-week medical in-patient rehabilitation in people with Rheumatoid Arthritis, run by University of Luebeck 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 4 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 29 Oct 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
work incapacity (incidence, duration) (time frame: baseline, 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00229541, which also lists 1 linked publication.
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 29 Oct 2007.