Participation Restrictions in Rheumatoid Arthritis

August 8, 2016 updated by: Júnia Amorim Andrade, Federal University of Minas Gerais

Factors Associated With Participation Restrictions in Individuals With Rheumatoid Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

81

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

For this cross-sectional study involved 81 individuals treated between June 2009 and August 2010 in Clinics Hospital, Universidade Federal de Minas Gerais in Belo Horizonte, Brazil. Recruted by convenience sampling

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: June 2009 to August 2010
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETIC 024/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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