Medical In-Patient Rehabilitation in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborators:
AOK Schleswig-Holstein
BEK Nord
Draeger and Hanse BKK
DAK Schleswig-Holstein
IKK Schleswig-Holstein
TK Schleswig-Holstein
LVA Schleswig-Holstein
BfA
Deutsche Rheumaliga Schleswig-Holstein
Berufsverband Deutscher Rheumatologen
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00229541
First received: September 27, 2005
Last updated: October 26, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Procedure: Counselling and 3-week medical in-patient rehabilitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medical In-Patient Rehabilitation in Rheumatoid Arthritis: Acceptance and Outcomes in Insurants of Compulsory Health Insurances and Statutory Pension Insurances (VERA)

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • work incapacity (incidence, duration) [ Time Frame: baseline, 12 months follow-up ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 129
Study Start Date: October 2003
Study Completion Date: March 2006
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229541

Locations
Germany
Institute for Social Medicine, University of Luebeck
Luebeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
AOK Schleswig-Holstein
BEK Nord
Draeger and Hanse BKK
DAK Schleswig-Holstein
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00229541     History of Changes
Other Study ID Numbers: FKZ 01GL0306
Study First Received: September 27, 2005
Last Updated: October 26, 2007
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University of Luebeck:
Medical in-patient rehabilitation
Gainfully employed
Work incapacity

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014