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NCT00783991 · ClinicalTrials.gov registry record
Investigating the Impact of Mode of Administration on Item Response
A clinical trial, sponsored by Stony Brook University.
- Completed
- Registry status
- 800
- Enrollment target
NCT00783991 is a clinical trial that has completed, run by Stony Brook University. The registered enrollment target is 800 participants.
The verdict
NCT00783991 has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- 800 participants
- Enrollment target
Study 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 i
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00783991
The ClinicalTrials.gov registry entry for NCT00783991 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00783991 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00783991 about?
NCT00783991 is a clinical study titled "Investigating the Impact of Mode of Administration on Item Response". 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 ...
What is the current status of trial NCT00783991?
This trial is currently completed. The enrollment target is 800 participants. The study started on 2009-04. Estimated completion is 2009-12.
Who is sponsoring clinical trial NCT00783991?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
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