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Medical In-Patient Rehabilitation in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Counselling and 3-week medical in-patient rehabilitation
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Medical in-patient rehabilitation, Gainfully employed, Work incapacity

Eligibility Criteria

20 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Social Medicine, University of Luebeck

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IG

KG

Arm Description

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)

control group, receives usual care

Outcomes

Primary Outcome Measures

work incapacity (incidence, duration)

Secondary Outcome Measures

general health status (SF-36)
Functional capacity (FFbH-P)
Quality of life (RAQoL)
Subjective prognosis of gainful employment (SPE-scale)
Somatization (SCL-90-R)
Depression

Full Information

First Posted
September 27, 2005
Last Updated
October 26, 2007
Sponsor
University of Luebeck
Collaborators
AOK Schleswig-Holstein, BEK Nord, Draeger and Hanse BKK, DAK Gesundheit, IKK Schleswig-Holstein, TK Schleswig-Holstein, LVA Schleswig-Holstein, BfA, Deutsche Rheumaliga Schleswig-Holstein, Berufsverband Deutscher Rheumatologen
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1. Study Identification

Unique Protocol Identification Number
NCT00229541
Brief Title
Medical In-Patient Rehabilitation in Rheumatoid Arthritis
Official Title
Medical In-Patient Rehabilitation in Rheumatoid Arthritis: Acceptance and Outcomes in Insurants of Compulsory Health Insurances and Statutory Pension Insurances (VERA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Medical in-patient rehabilitation, Gainfully employed, Work incapacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IG
Arm Type
Experimental
Arm Description
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)
Arm Title
KG
Arm Type
No Intervention
Arm Description
control group, receives usual care
Intervention Type
Procedure
Intervention Name(s)
Counselling and 3-week medical in-patient rehabilitation
Intervention Description
Counselling and 3-week medical in-patient rehabilitation in IG
Primary Outcome Measure Information:
Title
work incapacity (incidence, duration)
Time Frame
baseline, 12 months follow-up
Secondary Outcome Measure Information:
Title
general health status (SF-36)
Time Frame
baseline, 12 months follow-up
Title
Functional capacity (FFbH-P)
Time Frame
baseline, 12 months follow-up
Title
Quality of life (RAQoL)
Time Frame
baseline
Title
Subjective prognosis of gainful employment (SPE-scale)
Time Frame
baseline, 12 months follow-up
Title
Somatization (SCL-90-R)
Time Frame
baseline, 12 months follow-up
Title
Depression
Time Frame
baseline, 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiner Raspe, Prof.Dr.Dr.
Organizational Affiliation
Institute for Social Medicine, University of Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Social Medicine, University of Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17642037
Citation
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.
Results Reference
result
Links:
URL
http://www.sozmed.uni-luebeck.de
Description
homepage Institute for Social Medicine, University of Luebeck

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Medical In-Patient Rehabilitation in Rheumatoid Arthritis

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