Assessment of Body Image in Patients With Rheumatoid Arthritis (BIRA)
This study has been completed.
Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00832910
First received: January 29, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | January 29, 2009 | ||||
| Last Updated Date | January 29, 2009 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Body Dysmorphic Disorder Examination [ Time Frame: baseline ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of Body Image in Patients With Rheumatoid Arthritis | ||||
| Official Title ICMJE | Body Image in Patients With Rheumatoid Arthritis | ||||
| Brief Summary | Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem, function and quality of life. |
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| Detailed Description | Methods: Forty-three RA patients and thirty-nine control patients between 18 and 70 years were evaluated. The RA group was made up of individuals with a diagnosis of RA and the control group was made up of individuals from the community, paired for gender, age and body mass index. The patients were assessed with regard to body image (Body dysmorphic disorder examination (BDDE)), self-esteem (Rosenberg self-esteem scale), function (Health assessment questionnaire (HAQ)) and quality of life (Short form-36 (SF-36)). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: None Retained |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 82 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00832910 | ||||
| Other Study ID Numbers ICMJE | FDAAA | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Renata Trajano Borges e Jorge, Federal University of São Paulo | ||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Federal University of São Paulo | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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