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Medical In-Patient Rehabilitation in Rheumatoid Arthritis

Medical In-Patient Rehabilitation in Rheumatoid Arthritis: Acceptance and Outcomes in Insurants of Compulsory Health Insurances and Statutory Pension Insurances (VERA)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00229541
Enrollment
129
Registered
2005-09-29
Start date
2003-10-31
Completion date
2006-03-31
Last updated
2007-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Medical in-patient rehabilitation, Gainfully employed, Work incapacity

Brief 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 . 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: 1. 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) 2. screening questionnaire to verify in-/exclusion criteria 3. selection of eligible insurants (RA-criteria of American College of Rheumatology, clinical expert) 4. baseline measurement (e.g. SF-36, RAQoL, FFbH-P, SPE) 5. external stratified block by block randomization: intervention group (3- week medical in-patient rehabilitation) vs. control group (usual care) 6. follow-up measurement (12 months after baseline) 7. 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.

Interventions

PROCEDURECounselling and 3-week medical in-patient rehabilitation

Counselling and 3-week medical in-patient rehabilitation in IG

Sponsors

AOK Schleswig-Holstein
CollaboratorINDUSTRY
BEK Nord
CollaboratorUNKNOWN
Draeger and Hanse BKK
CollaboratorINDUSTRY
DAK Gesundheit
CollaboratorOTHER
IKK Schleswig-Holstein
CollaboratorUNKNOWN
TK Schleswig-Holstein
CollaboratorUNKNOWN
LVA Schleswig-Holstein
CollaboratorUNKNOWN
BfA
CollaboratorUNKNOWN
Deutsche Rheumaliga Schleswig-Holstein
CollaboratorUNKNOWN
Berufsverband Deutscher Rheumatologen
CollaboratorUNKNOWN
University of Luebeck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 62 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
work incapacity (incidence, duration)baseline, 12 months follow-up

Secondary

MeasureTime frame
Functional capacity (FFbH-P)baseline, 12 months follow-up
Quality of life (RAQoL)baseline
general health status (SF-36)baseline, 12 months follow-up
Somatization (SCL-90-R)baseline, 12 months follow-up
Depressionbaseline, 12 months follow-up
Subjective prognosis of gainful employment (SPE-scale)baseline, 12 months follow-up

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026