Initial Validation of PROMIS Physical Function/Disability Scales in Rheumatoid Arthritis (RA)

NCT00786227 | Completed

• 3 other identifiers: 07-015U01AR0521585U01AR052158-02
• Study Type: observational
• Target: 761
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 at 6 and 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from three sources will be included in the study: ARAMIS RA cohort, Stanford RA registry, and Stanford RA clinical trials patients.

You may qualify if:

• 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

You may not qualify if:

• Unable or unwilling to complete questionnaires

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• QualityMetrics: collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• James F. Fries, MD

  Stanford School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)