Rheumatoid ArthritisNCT00412399
Job Adaptation in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hospital for Special Surgery, New York at 2 sites in United States.
Trial summary
The specific aim of this study is to compare the rate of negative work role events in individuals with rheumatoid arthritis compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 244 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 1999to Oct 2001
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are eligible if they are:
- over age 18;
- meet American Rheumatism Association criteria for rheumatoid arthritis; and
- are employed for salary or monetary reimbursement.
- Controls are eligible if they are:
- over age 18;
- have no major comorbidity; and
- are employed for salary or monetary reimbursement.
Who cannot join
- Patients and controls are excluded if they:
- have cognitive deficits and cannot provide informed consent;
- do not speak English or Spanish; or
- their physicians do not grant permission to enroll them.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cornell Internal Medicine Associates
New York, New York, 10021
Hospital for Special Surgery
New York, New York, 10021
About this study
The specific aim of this study is to compare the rate of negative work role events in individuals with rheumatoid arthritis compared to healthy controls.
Read the detailed description
Rheumatoid arthritis can cause multiple socio-medical disabilities, with work disability among the most marked. While a major focus has been documenting the rates of job loss and returning patients to the workforce, there is little information about how to foster job retention in those still employed. The goals of this study are to document negative workplace events over 1 year in 122 employed patients with rheumatoid arthritis, and to compare these to 122 healthy controls, who are included to account for the effects of socioeconomic status on employment. Events will be recorded with the work domain of the Psychiatric Epidemiology Research Life Events Scale. Additional goals are to compared fatigue, physical activity, functional status and sleep disturbances as covariates.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Employment, Negative workplace events, Healthy controls, Fatigue, Physical activity
- Medical subject headings
- Arthritis, Rheumatoid, Fatigue, Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startJun 1999
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- 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
- Observational model
- Natural history
- Time perspective
- Prospective
- Enrolment
- 244 participants
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Investigators
- Carol A Mancuso, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412399
- Sponsor's protocol ID
- 97068
- Status last verified
- Dec 2006
- First submitted
- 15 Dec 2006
- Last updated
- 18 Dec 2006
- Results posted
- No
Publications
Mancuso CA, Paget SA, Charlson ME. Adaptations made by rheumatoid arthritis patients to continue working: a pilot study of workplace challenges and successful adaptations. Arthritis Care Res. 2000 Apr;13(2):89-99.
PubMed 14635282
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Job Adaptation in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00412399
- Acronym / sponsor ID
- 97068
- Conditions
- Rheumatoid Arthritis
- Keywords
- Employment, Negative workplace events, Healthy controls, Fatigue, Physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Jun 1999
- Study completion
- Oct 2001
- First posted
- 18 Dec 2006 (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.
The specific aim of this study is to compare the rate of negative work role events in individuals with rheumatoid arthritis compared to healthy controls.
Detailed description
Rheumatoid arthritis can cause multiple socio-medical disabilities, with work disability among the most marked. While a major focus has been documenting the rates of job loss and returning patients to the workforce, there is little information about how to foster job retention in those still employed. The goals of this study are to document negative workplace events over 1 year in 122 employed patients with rheumatoid arthritis, and to compare these to 122 healthy controls, who are included to account for the effects of socioeconomic status on employment. Events will be recorded with the work domain of the Psychiatric Epidemiology Research Life Events Scale. Additional goals are to compared fatigue, physical activity, functional status and sleep disturbances as covariates.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients are eligible if they are:
- Controls are eligible if they are:
Key exclusion criteria (4 listed)
- Patients and controls are excluded if they:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 18 Dec 2006.
- Background: PubMed 14635282Mancuso CA, Paget SA, Charlson ME. Adaptations made by rheumatoid arthritis patients to continue working: a pilot study of workplace challenges and successful adaptations. Arthritis Care Res. 2000 Apr;13(2):89-99.
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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.
Carol A Mancuso, MD principal investigator
Hospital for Special Surgery, New York
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hospital for Special Surgery, New York at 2 sites in United States.
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 8 inclusion and 4 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 18 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412399, which also lists 1 linked publication.
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 18 Dec 2006.