Investigating the Impact of Mode of Administration on Item Response

NCT00783991 | Completed

• 2 other identifiers: 07-055U01AR052170-02
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

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. This study is designed to examine how differences in modes of data capture affect psychometric properties and score differences and to evaluate the consistency of these results across three PROMIS health domains: emotional distress-depression, fatigue, and physical function. Four modes of administration will be compared: interactive voice response (IVR) technology, paper and pencil questionnaire, personal computer, and personal digital assistant (PDA). A total of 800 patients will be enrolled from three diagnostic groups: chronic obstructive pulmonary disease (COPD), depression, and rheumatoid arthritis. The study will test for equivalence across modes of administration, with the hypothesis that there are no mode effects; if mode effects are found, their magnitude across modes will be estimated. This network project will result in an improved understanding of the effect of assessment mode on patient-reported outcome (PRO) data. Guidance from this project can help in planning future PROMIS activities beyond the present PROMIS program.

Conditions

Chronic Obstructive Pulmonary Disease; Depression; Rheumatoid Arthritis

Keywords

IVF; PDA; PC; CAT; COPD; MDD; RA

Outcome Measures

Primary Outcomes (2)

• IRT-derived scores from two parallel static short forms containing eight items each from three PROMIS domains (emotional distress-depression, fatigue, physical function)

  One time assessment

• Respondent preference and satisfaction with mode of administration

  One time assessment

Study Arms (4)

IVR-PC

This group will have instruments administered through interactive voice response (IVR) and personal computer (PC).

PP-PC

This group will have instruments administered through paper and pencil (PP) and PC.

PDA-PC

This group will have instruments administered by personal digital assistant (PDA) and PC.

PC-PC

This group will have all instruments administered through PC.

Eligibility Criteria

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

Study Population

Community samples with at least one of these conditions: chronic obstructive pulmonary disease (COPD), depression (DEP), or rheumatoid arthritis (RA).

You may qualify if:

• Diagnosis given by treating physician
• Respondents required to take one or more of the following medications for their treatment:
• COPD: Inhalative steroids (e.g., budesonide, beclometasone), oral medication with theophylline (dimethylxanthine), 2 mimetic (e.g., formoterol, salmeterol), leukotriene antagonists (e.g., montelukast), or oral corticosteroids (e.g., prednisolone)
• DEP: Anti-depressive drugs (e.g., mirtazapine, escitalopram) and/or received a recognized psychotherapeutic treatment for depression within the last year
• RA: Anti-inflammatory medications (e.g., Cox-2 inhibitors, acetylsalicylic acid of more than 500mg/d, diclofenac, ibuprofen), immunosuppressants (e.g., methotrexate, leflunomide), immune modulators (e.g., infliximab, etanercept), or steroids (e.g., prednisolone) for current treatment of RA
• Fluent in English
• Have Internet access and an e-mail address (for the IVR-PC, PP-PC and PC-PC arms)
• Willing and able to give informed consent

Sponsors & Collaborators

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

Study Sites (2)

Polimetrix

Palo Alto, California, 94301, United States

Location

Rheumatology Associates of Long Island

Smithtown, New York, 11787, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Depression; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John E. Ware, PhD

  QualityMetrics

  PRINCIPAL INVESTIGATOR

• Arthur Stone, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 3, 2008
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 6, 2013

Record last verified: 2013-06

Locations

US (2)