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Trial record 15 of 1481 for:    rheumatoid arthritis | rheumatoid arthritis
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Assessment of Body Image in Patients With Rheumatoid Arthritis (BIRA)

This study has been completed.
Sponsor:
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
  Purpose

Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem, function and quality of life.


Condition
Body Image
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Body Image in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Body Dysmorphic Disorder Examination [ Time Frame: baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Short Form - 36 [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Health assessment questionnaire [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Rosenberg self-esteem scale [ Time Frame: baseline ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

None Retained


Enrollment: 82
Study Start Date: June 2007
Study Completion Date: December 2008
Groups/Cohorts
Rheumatoid Arthritis group1
This group had patients with rheumatoid arthritis
2

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)).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Rheumatoid arthritis in study group
  • Community sample in control group
Criteria

Inclusion Criteria:

  • The RA group included patients between 18 and 70 years of age, of either gender, with an established diagnosis of RA based ACR criteria and belonging to functional classes I, II and III. The control group was made up of individuals from the community paired for gender, age and body mass index with RA group.

Exclusion Criteria:

  • Individuals with fibromyalgia, neurological disease, psychiatric disorders or other severe co-morbidity were excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832910

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Jamil Natour, Professor Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Renata Trajano Borges e Jorge, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00832910     History of Changes
Other Study ID Numbers: FDAAA
Study First Received: January 29, 2009
Last Updated: January 29, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Body image
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013