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Medical In-Patient Rehabilitation in Rheumatoid Arthritis

NCT ID: NCT00229541

Last Updated: 2007-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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Medical in-patient rehabilitation Gainfully employed Work incapacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Counselling and 3-week medical in-patient rehabilitation

Intervention Type PROCEDURE

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

KG

control group, receives usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Counselling and 3-week medical in-patient rehabilitation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AOK Schleswig-Holstein

INDUSTRY

Sponsor Role collaborator

BEK Nord

UNKNOWN

Sponsor Role collaborator

Draeger and Hanse BKK

INDUSTRY

Sponsor Role collaborator

DAK Gesundheit

OTHER

Sponsor Role collaborator

IKK Schleswig-Holstein

UNKNOWN

Sponsor Role collaborator

TK Schleswig-Holstein

UNKNOWN

Sponsor Role collaborator

LVA Schleswig-Holstein

UNKNOWN

Sponsor Role collaborator

BfA

UNKNOWN

Sponsor Role collaborator

Deutsche Rheumaliga Schleswig-Holstein

UNKNOWN

Sponsor Role collaborator

Berufsverband Deutscher Rheumatologen

UNKNOWN

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role lead

Principal Investigators

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Heiner Raspe, Prof.Dr.Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute for Social Medicine, University of Luebeck

Locations

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Institute for Social Medicine, University of Luebeck

Lübeck, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 17642037 (View on PubMed)

Related Links

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http://www.sozmed.uni-luebeck.de

homepage Institute for Social Medicine, University of Luebeck

Other Identifiers

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FKZ 01GL0306

Identifier Type: -

Identifier Source: org_study_id