Participation Restrictions in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Factors Associated With Participation Restrictions in Individuals With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863653
• Other study ID #: ETIC 024/09
• Status: Completed
• Phase: N/A
• First received: July 20, 2016
• Last updated: August 8, 2016
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: July 2016
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Conselho Nacional de Saúde (CNS) / Resolução 466/12
• Study type: Observational

Clinical Trial Summary

Objective: To evaluate what factors contribute to social participation restrictions in subjects with Rheumatoid Arthritis (RA), considering the model International Classification of Functioning (ICF).

Methods: Cross-sectional study with 81 individuals with Rheumatoid Arthritis, using instruments to measure two constructs of component social participation.

Description:

In this study the definition of social participation considered several areas, such as marriage and family, work, leisure, religion, economy, and politics which are based in the social scales of the questionnaires SF-36 and AIMS2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 18 years of age

• Mental capacity as assessed by the Brazilian version of Mini Mental State Examination

• Diagnosis of RA according to the American College of Rheumatology (ACR) 1987 criteria established by attending service rheumatologist.

Exclusion Criteria:

• Individuals who had undergone surgery of the upper limbs, were unable to comply with the protocol for data collection, or with non-corrected visual deficits that could interfere with their functionality were excluded

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• observational study
application of several standard instruments in patients with rheumatoid arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Short Form Instruments (social aspect) and Arthritis Impact Measurement Scale (social interaction) were used as outcome measures to assess the social participation according to the International Classification of Functioning, Disability and Health	We evaluated 81 individuals in a single meeting with the SF-36 and AIMS2, each participant was assessed for 2 hours. The revised AIMS2 comprises five main dimensions. The score of each AIMS scale varies from zero to 10 (a score of 10 indicates the worst state of health). The SF-36 is a generic instrument that assesses quality of life and comprises eight dimensions. The SF-36 final score varies from zero to 100 in each of the eight dimensions (a score of 100 represents the best state of health).	June 2009 to August 2010	No