NCT02863653

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

July 20, 2016

Last Update Submit

August 8, 2016

Conditions

Keywords

social participationInternational Classification of Functioning

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

application of several standard instruments in patients with rheumatoid arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Observation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

July 20, 2016

First Posted

August 11, 2016

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

August 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share