Medical In-Patient Rehabilitation in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229541
• Other study ID #: FKZ 01GL0306
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: October 26, 2007
• Start date: October 2003
• Est. completion date: March 2006

Study information

• Verified date: October 2007
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical 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 . Additionally, the feasibility to recruit a study population via databases of compulsory health insurances is examined.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 62 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Procedure:
• Counselling and 3-week medical in-patient rehabilitation
Counselling and 3-week medical in-patient rehabilitation in IG

Locations

Country	Name	City	State
Germany	Institute for Social Medicine, University of Luebeck	Luebeck

Sponsors (11)

Lead Sponsor	Collaborator
University of Luebeck	AOK Schleswig-Holstein, BEK Nord, Berufsverband Deutscher Rheumatologen, BfA, DAK Schleswig-Holstein, Deutsche Rheumaliga Schleswig-Holstein, Draeger and Hanse BKK, IKK Schleswig-Holstein, LVA Schleswig-Holstein, TK Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schlademann S, Hüppe 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 (clin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	work incapacity (incidence, duration)		baseline, 12 months follow-up
Secondary	general health status (SF-36)		baseline, 12 months follow-up
Secondary	Functional capacity (FFbH-P)		baseline, 12 months follow-up
Secondary	Quality of life (RAQoL)		baseline
Secondary	Subjective prognosis of gainful employment (SPE-scale)		baseline, 12 months follow-up
Secondary	Somatization (SCL-90-R)		baseline, 12 months follow-up
Secondary	Depression		baseline, 12 months follow-up

External Links

•   homepage Institute for Social Medicine, University of Luebeck