RheumatoId ArthritisNCT02968745
Occupational Performance Problems in Individuals With Rheumatoid Arthritis
An observational study of RheumatoId Arthritis, run by Federal University of Minas Gerais.
Trial summary
Aim: To identify the main occupational performance problems reported by individuals with rheumatoid arthritis and the relationship between these activities with work status of participants . Methods: the investigators conducted a cross-sectional study with 81 patients with RA. Read more about this study
- Who is it for?
- Ages 46 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- RheumatoId Arthritis
- What is being tested?
- Observational study
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: For this cross-sectional study, 81 patients treated between 2009 and August 2010 in clinical Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil werw recruited by convenience sampling
Who may be able to join
- over 46 years old;
- diagnosed with RA by rheumatologist (American College of Rheumatology);
- mental competency as assessed with the Mental State Mini-Examination;
- possessed the skills to understand the instructions study.
Who cannot join
- had undergone surgery in the upper limbs.
About this study
Official title: Occupational Performance Problems Frequently Reported by Individuals With Rheumatoid Arthritis
Aim: To identify the main occupational performance problems reported by individuals with rheumatoid arthritis and the relationship between these activities with work status of participants . Methods: the investigators conducted a cross-sectional study with 81 patients with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was described in frequencies and percentages, and the Pearson's chi-square test was used to determine the asymptotic association between the occupational performance problems with work.
Read the detailed description
For this cross-sectional study, 81 patients were recruited by convenience at the Clinical Hospital (HC) of the Universidade Federal de Minas Gerais (UFMG), in Brazil.
COPM was applied to identify the main occupational performance problems reported by participants. The COPM is an individual measure of self-awareness about the problems faced when carrying out the activities. It identifies problems in the areas of self-care, productivity, and leisure, and measure the individual's performance and satisfaction regarding these activities
- Conditions
- RheumatoId Arthritis
- Being tested
- Observational study
- Keywords
- Rheumatoid arthritis, human activity, Canadian Occupational Performance Measure
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Canadian Occupational Performance Measure (COPM) was applied to identify the main occupational performance problems
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10 (a score of one indicated no importance and a score of 10 indicated extreme importance),
Measured: June 2009 to August 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RheumatoId ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Júnia Amorim Andrade, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968745
- Sponsor's protocol ID
- UFMG ETIC 024/09
- Status last verified
- Nov 2016
- First submitted
- 13 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not plan to Share IPD
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Performance Problems Frequently Reported by Individuals With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02968745
- Acronym / sponsor ID
- UFMG ETIC 024/09
- Conditions
- RheumatoId Arthritis
- Keywords
- Rheumatoid arthritis, human activity, Canadian Occupational Performance Measure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To identify the main occupational performance problems reported by individuals with rheumatoid arthritis and the relationship between these activities with work status of participants . Methods: the investigators conducted a cross-sectional study with 81 patients with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was described in frequencies and percentages, and the Pearson's chi-square test was used to determine the asymptotic association between the occupational performance problems with work.
Detailed description
For this cross-sectional study, 81 patients were recruited by convenience at the Clinical Hospital (HC) of the Universidade Federal de Minas Gerais (UFMG), in Brazil.
COPM was applied to identify the main occupational performance problems reported by participants. The COPM is an individual measure of self-awareness about the problems faced when carrying out the activities. It identifies problems in the areas of self-care, productivity, and leisure, and measure the individual's performance and satisfaction regarding these activities
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 46 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- For this cross-sectional study, 81 patients treated between 2009 and August 2010 in clinical Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil werw recruited by convenience sampling
Key inclusion criteria (4 listed)
- over 46 years old;
- diagnosed with RA by rheumatologist (American College of Rheumatology);
- mental competency as assessed with the Mental State Mini-Examination;
- possessed the skills to understand the instructions study.
Key exclusion criteria (1 listed)
- had undergone surgery in the upper limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyCanadian Occupational Performance Measure (COPM) was applied to identify the main occupational performance problems | Other | – |
Primary outcome
Canadian Occupational Performance Measure
Time frame: June 2009 to August 2010
The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10 (a score of one indicated no importance and a score of 10 indicated extreme importance),
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Individual participant dataSharing planned: No. Not plan to Share IPD
Related trials for RheumatoId Arthritis
Active, not recruitingObservational study
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Rheumatoid Arthritis, Ankylosing Spondylitis
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of RheumatoId Arthritis, run by Federal University of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: June 2009 to August 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.