Rheumatoid ArthritisNCT00786227
Initial Validation of PROMIS Physical Function/Disability Scales in Rheumatoid Arthritis (RA)
An observational study of Rheumatoid Arthritis, run by Stanford University at 1 site in United States.
Trial summary
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 761 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2009
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients from three sources will be included in the study: ARAMIS RA cohort, Stanford RA registry, and Stanford RA clinical trials patients.
Who may be able to join
- Rheumatologist-diagnosed RA
- Meets one of the conditions for treatment intensification as described in the protocol
- Ability to read, write, and speak English
- Ability to understand and provide informed consent
Who cannot join
- Unable or unwilling to complete questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.
Read the detailed description
This is a longitudinal clinical validation study of the PROMIS physical function, fatigue, and pain impact short forms in patients with rheumatoid arthritis (RA). Patients will complete assessments at two points: baseline and 6 months post-baseline. The responsiveness of six PROMIS static forms (physical function [HAQ, PF-10, 10 and 20 item short forms], fatigue, and pain impact) will be evaluated for change over the 6-month period. Physical function change scores will be contrasted with established Legacy physical function instruments. The test of "responsiveness" is defined as the ability of the instrument to detect change after major treatment intensification, self-reported improvement in functioning, or positive changes in patient global scores. The order of presentation of forms will be randomly assigned to eliminate questionnaire fatigue or other order effects as factors. We will also evaluate the test-retest reliability of four PROMIS static forms (HAQ and PF-10 physical function, fatigue, and pain impact) in a random subsample of patients at 1-week post-baseline. In addition, we will evaluate convergent validity of PROMIS measures of physical function by comparing self-report with observation of performance of physical function tasks in a subsample of patients randomly selected from the local geographic region.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Legacy HAQ-DI first, PROMIS 20-item short form first | To eliminate effects due to order of administration, patients with RA will be randomized to complete either the Legacy measure HAQ-DI first in the assessment battery or the PROMIS 20-item short forms first. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of Legacy or PROMIS instruments to detect change over 6 and 12 months in RA: (a) when an anti-TNF drug has been begun, (b) when the patient reports improvement over the prior period, (c) when the patient global has improved over the prior period
Measured: Measured at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionJul 2009
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.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), QualityMetrics
- Responsible party
- Sponsor
- Investigators
- James F. Fries, MD, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786227
- Sponsor's protocol ID
- 07-01
- Other IDs
- 5U01AR052158, 5U01AR052158-02
- Status last verified
- May 2013
- First submitted
- 5 Nov 2008
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Validation of PROMIS Physical Function/Disability Scales in Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT00786227
- Acronym / sponsor ID
- 07-01
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), QualityMetrics
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Nov 2008 (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 Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.
Detailed description
This is a longitudinal clinical validation study of the PROMIS physical function, fatigue, and pain impact short forms in patients with rheumatoid arthritis (RA). Patients will complete assessments at two points: baseline and 6 months post-baseline. The responsiveness of six PROMIS static forms (physical function [HAQ, PF-10, 10 and 20 item short forms], fatigue, and pain impact) will be evaluated for change over the 6-month period. Physical function change scores will be contrasted with established Legacy physical function instruments. The test of "responsiveness" is defined as the ability of the instrument to detect change after major treatment intensification, self-reported improvement in functioning, or positive changes in patient global scores. The order of presentation of forms will be randomly assigned to eliminate questionnaire fatigue or other order effects as factors. We will also evaluate the test-retest reliability of four PROMIS static forms (HAQ and PF-10 physical function, fatigue, and pain impact) in a random subsample of patients at 1-week post-baseline. In addition, we will evaluate convergent validity of PROMIS measures of physical function by comparing self-report with observation of performance of physical function tasks in a subsample of patients randomly selected from the local geographic region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Legacy HAQ-DI first, PROMIS 20-item short form first | – | –To eliminate effects due to order of administration, patients with RA will be randomized to complete either the Legacy measure HAQ-DI first in the assessment battery or the PROMIS 20-item short forms first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from three sources will be included in the study: ARAMIS RA cohort, Stanford RA registry, and Stanford RA clinical trials patients.
Key inclusion criteria (4 listed)
- Rheumatologist-diagnosed RA
- Meets one of the conditions for treatment intensification as described in the protocol
- Ability to read, write, and speak English
- Ability to understand and provide informed consent
Key exclusion criteria (1 listed)
- Unable or unwilling to complete questionnaires
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
Ability of Legacy or PROMIS instruments to detect change over 6 and 12 months in RA: (a) when an anti-TNF drug has been begun, (b) when the patient reports improvement over the prior period, (c) when the patient global has improved over the prior period
Time frame: Measured at 6 and 12 months
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 3 May 2013.
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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.
James F. Fries, MD principal investigator
Stanford School of Medicine
1 site 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 Stanford University at 1 site 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 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 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Ability of Legacy or PROMIS instruments to detect change over 6 and 12 months in RA: (a) when an anti-TNF drug has been begun, (b) when the patient reports improvement over the prior period, (c) when the patient global has improved over the prior period (time frame: Measured at 6 and 12 months). 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 3 May 2013.