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| Name | Class |
|---|---|
| AOK Schleswig-Holstein | INDUSTRY |
| BEK Nord | UNKNOWN |
| Draeger and Hanse BKK | INDUSTRY |
| DAK Gesundheit |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| KG | No Intervention | control group, receives usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counselling and 3-week medical in-patient rehabilitation | Procedure | Counselling and 3-week medical in-patient rehabilitation in IG |
|
| Measure | Description | Time Frame |
|---|---|---|
| work incapacity (incidence, duration) | baseline, 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| general health status (SF-36) | baseline, 12 months follow-up | |
| Functional capacity (FFbH-P) | baseline, 12 months follow-up | |
| Quality of life (RAQoL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heiner Raspe, Prof.Dr.Dr. | Institute for Social Medicine, University of Luebeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Social Medicine, University of Luebeck | Lübeck | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17642037 | Result | 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. |
| Label | URL |
|---|---|
| homepage Institute for Social Medicine, University of Luebeck | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| OTHER |
| IKK Schleswig-Holstein | UNKNOWN |
| TK Schleswig-Holstein | UNKNOWN |
| LVA Schleswig-Holstein | UNKNOWN |
| BfA | UNKNOWN |
| Deutsche Rheumaliga Schleswig-Holstein | UNKNOWN |
| Berufsverband Deutscher Rheumatologen | UNKNOWN |
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| baseline |
| Subjective prognosis of gainful employment (SPE-scale) | baseline, 12 months follow-up |
| Somatization (SCL-90-R) | baseline, 12 months follow-up |
| Depression | baseline, 12 months follow-up |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005159 | Health Care Facilities Workforce and Services |