Medical In-Patient Rehabilitation in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

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:

        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.
    

Intervention name(s): Counselling and 3-week medical in-patient rehabilitation
Intervention type(s): Procedure
Intervention description(s): Counselling and 3-week medical in-patient rehabilitation in IG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medical in-patient rehabilitation; Gainfully employed; Work incapacity