Status:
COMPLETED
Investigating the Impact of Mode of Administration on Item Response
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
QualityMetrics
Conditions:
Chronic Obstructive Pulmonary Disease
Depression
Eligibility:
All Genders
18+ years
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...
Detailed Description
This study is designed to systematically test the impact of mode of administration on patient-reported outcomes measures included in the PROMIS item banks. It is designed as a randomized cross-over st...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00783991
Start Date
April 1 2009
End Date
December 1 2009
Last Update
June 6 2013
Active Locations (2)
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1
Polimetrix
Palo Alto, California, United States, 94301
2
Rheumatology Associates of Long Island
Smithtown, New York, United States, 11787