Dyslipidemia Clinical Trial
Official title:
A Randomized, Double-blind, Parallel, Multicenter, Placebo-controlled, Prospective Study to Evaluate the Functionality of the Flushing ASsessment Tool (FAST) in Subjects Administered Niaspan® Plus Acetylsalicylic Acid (ASA), Niaspan® Plus ASA Placebo or Niaspan® Placebo Plus ASA Placebo Daily for Six Weeks
The primary purpose of this study was to evaluate the psychometric characteristics
(reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects
receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks.
The FAST is a questionnaire that was developed to provide a detailed assessment of flushing
symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on
flushing symptoms, as measured by the FAST, was also evaluated.
This study was designed to evaluate the psychometric characteristics of the FAST
questionnaire.
The FAST is a self-administered questionnaire, completed using a hand-held electronic data
capture device (LogPad e-diary). Subjects recorded the start and stop date and time of each
flushing event, the presence and severity of individual flushing symptoms (redness, warmth,
tingling and/or itching), and an overall assessment of their flushing experience.
Evaluation of the psychometric characteristics of the FAST was based on 3 primary data
analyses: 1 ) test-retest reliability based on the intraclass correlation coefficient; 2)
construct validity based on Spearman correlation coefficients; and 3) responsiveness based
on changes in FAST scores. The mean and maximum severity of flushing events, as measured by
the FAST, were the primary variables evaluated in each of the 3 data analyses mentioned
above. Psychometric analyses were performed blinded to treatment group assignment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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