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)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Procedure: Counselling and 3-week medical in-patient rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Luebeck, Germany, 23538
    • Institute for Social Medicine, University of Luebeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IG; 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)	Procedure: Counselling and 3-week medical in-patient rehabilitation; Counselling and 3-week medical in-patient rehabilitation in IG
No Intervention: KG; control group, receives usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
work incapacity (incidence, duration)	baseline, 12 months follow-up

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Luebeck
• Collaborators: DAK Gesundheit; AOK Schleswig-Holstein; BEK Nord; Draeger and Hanse BKK; IKK Schleswig-Holstein; TK Schleswig-Holstein; LVA Schleswig-Holstein; BfA; Deutsche Rheumaliga Schleswig-Holstein; Berufsverband Deutscher Rheumatologen
• Investigators: Principal Investigator: Heiner Raspe, Prof.Dr.Dr., Institute for Social Medicine, University of Luebeck

Publications and helpful links

General 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.

Helpful Links

• homepage Institute for Social Medicine, University of Luebeck

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: September 27, 2005
• First Submitted That Met QC Criteria: September 27, 2005
• First Posted (Estimate): September 29, 2005

Study Record Updates

• Last Update Posted (Estimate): October 29, 2007
• Last Update Submitted That Met QC Criteria: October 26, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Medical in-patient rehabilitation; Gainfully employed; Work incapacity
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: FKZ 01GL0306