An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
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|ClinicalTrials.gov Identifier: NCT00681759|
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : October 31, 2008
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1836 participants|
|Official Title:||A Prospective Descriptive, Multi-National, Multi-Centre Observational Study of Burden of Upper GI-Symptoms in Subjects With Cardiovascular Risk or Disease Receiving Treatment With Low-Dose Aspirin|
|Study Start Date :||January 2008|
|Actual Study Completion Date :||September 2008|
Patients who have been prescribed Low Dose Aspirin (LDA) usage in the past 12 months, or those about to begin LDA, will complete a one-time in-office survey using an electronic personal digital assistant (PDA) device (termed SitePro).
420 subjects stratified into three groups varying on length of time using Low Dose Aspirin (LDA)
Up to 20 subjects from the three EMA groups will be interviewed to further debrief their experience with Low Dose Aspirin (LDA) and upper GI symptoms.
- Cross-sectional survey, SitePro Survey Domains including; background, UGI screening, PPI and H2 blocker usage, interaction between UGI and LDA ,UGI symptoms, HADS, Morisky Medication Taking Behavior Scale, SF12, SSA-P [ Time Frame: Once at enrollment ]
- EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization [ Time Frame: Four times daily for three months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681759
|United States, Tennessee|
|Brentwood, Tennessee, United States|
|St. Laurent, Quebec, Canada|