COAG study visit and data collection schedule.
Month 1 | Month 1 | Month 1 | Month 1 | Month 2* | Month 3 | Month 4* | Month 5* | Month 6 | ||||
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Baseline | Week 1 | Week 2 | Week 3 | Week 4 | ||||||||
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Day -1/0 | Day 4 | Day 7 | Day A | Day B | ||||||||
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Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | Visit 10 | Visit 11 | Visit 12 | |
Informed consent | X | |||||||||||
Participant contact information | X | X | X | X | X | X | X | X | X | X | X | X |
Enrollment information | X | |||||||||||
Eligibility confirmation | X | |||||||||||
Randomization | X | |||||||||||
Genotyping information | X | |||||||||||
Dose requisition information | X | X | X | X | X | X | X | PRN | PRN | PRN | PRN | PRN |
Personal history | X | |||||||||||
Medical history | X | |||||||||||
Diet information | X | X | X | X | X | X | X | |||||
EQ-5D Health Questionnaire | X | X | X | X | ||||||||
Health Status Questionnaire | X | X | X | |||||||||
INRs | X | X | X | X | X | X | X | X | X | X | X | X |
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X |
Concomitant medications | X | X | X | X | X | X | X | X | X | |||
Medical events | X | X | X | X | X | X | X | X | X | X | X | |
Hospitalization information | PRN | PRN | PRN | PRN | PRN | PRN | PRN | PRN | PRN | PRN | PRN | |
Duke Anti-Coagulation Satisfaction Survey | PRN | PRN | PRN | PRN | PRN | |||||||
Adherence Questionnaire | PRN | PRN | PRN | PRN |
These visits may be conducted by telephone.