NCT02730286

Brief Summary

Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Health model. Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using instruments to measure five constructs of the component activities.

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

Click on a node to explore related trials.

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
5.7 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

March 29, 2016

Last Update Submit

March 31, 2016

Conditions

Keywords

human activityInternational Classification of Functioning

Outcome Measures

Primary Outcomes (4)

  • Model 1- Test d´Evaluation dês Membres Supérieurs de Personnes Agées, - TEMPA rheumatoid arthritis

    The TEMPA is assessing the performance of the upper extremities and consists of eight standardized tasks. Scoring of the task analysis dimension ranges from zero to 150 (a score of zero indicates no disability). The TEMPA is scored according to the time required (in seconds) to complete each task; the higher the score, the greater the disability

    up to thirty minutes

  • Model 2- Sequential Occupational Dexterity Assessment (SODA)

    The SODA in patient population with RA score ranges from zero to 108 across these 12 tasks, has been validated for RA patients

    up to thirty minutes

  • Model 3 and 4- SF-36=Short form health survey-36

    The SF-36 has eight scales and a final score ranging from zero to 100 for each of the eight dimensions (a score of 100 represents the best state of health). The Brazilian Portuguese version of the SF-36 in patient population with RA has been demonstrated to be a reproducible and valid.

    up to thirty minutes

  • Model 5 - AIMS=Arthritis impact measurement scale

    The score ranges from zero to 10 (a score of 10 indicates the worst state of health) in patient population with RA. The Portuguese version of AIMS2 has been shown to be satisfactory

    up to thirty minutes

Interventions

application of several standard instruments in patients with rheumatoid arthritis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

For this cross-sectional study, 81 patients treated between June 2009 and August 2010 in Clinics Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil were recruited by convenience sampling

You may qualify if:

  • Age over 18 years,
  • Clinical diagnosis rheumatic arthritis
  • Mental competence by the Mini-Mental State Examination

You may not qualify if:

  • Had undergone upper limb surgery,
  • Had an uncorrected visual deficit that could compromise functionality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Andrade JA, Brandao MB, Pinto MR, Lanna CC. Factors Associated With Activity Limitations in People With Rheumatoid Arthritis. Am J Occup Ther. 2016 Jul-Aug;70(4):7004290030p1-7. doi: 10.5014/ajot.2016.017467.

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 Júnia Amorim Andrade

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 6, 2016

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

April 6, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share