Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229541
Status:
COMPLETED
Last Update Posted:
2007-10-29
First Post:
2005-09-27
Brief Title:
Medical In-Patient Rehabilitation in Rheumatoid Arthritis
Sponsor:
University of Luebeck
Organization:
University of Luebeck
Study Overview
Official Title:
Medical In-Patient Rehabilitation in Rheumatoid Arthritis Acceptance and Outcomes in Insurants of Compulsory Health Insurances and Statutory Pension Insurances VERA
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 Recruitment of a potential study population via health insurance data defined search criteria ICD-10 diagnoses M05061379 in case of work disabilityhospital 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 eg 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
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 M05061379 in case of work disabilityhospital 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None