An observational study in Atrial Fibrillation, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Duke University · Observational
This study will survey atrial fibrillation patients to better understand patient perspective of DOAC treatment, and providers to assess knowledge, practice patterns, and beliefs surrounding anticoagulation for AF.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 581 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study is targeting AF patients and providers.
Retrospective Analysis:
Prospective Analysis:
Exclusion Criteria:
Retrospective Analysis:
Prospective Analysis:
Patients registered on ResearchMatch.org with Atrial Fibrillation as a medical condition; or who participate in afib-related social media platforms and confirm a diagnosis of afib, will be invited to participate in this study. Patients will be consented using an online consent form and then will be asked to complete 1 survey that contains scenarios and ranking questions.
Providers who have contributed at least 25 Atrial Fibrillation patients to the Symphony pharmacy claims dataset will be contacted to participate. Interested providers will be consented using an online consent form and then will be asked to complete 1 survey that contains scenarios and ranking questions.
The co-primary outcome for the retrospective analysis is rate of 12-month medication discontinuation.
The pharmacy claims dataset will be used to obtain records of patient prescription fills, and the characteristics of those patients filling the prescriptions. The index event for each patient will be defined by when the second NVAF claim was filed. The dose will be initially determined from the index prescription. Of those patients prescribed a DOAC, the 12-month DOAC discontinuation rates will be examined. DOAC discontinuation will be defined as a gap in fill ≥30 days following the run-out date of the last observed claim for the index therapy. Twelve-month DOAC discontinuation will be stratified according to whether the patient received a dose reduction following labeled criteria, a dose reduction inconsistent with labeled criteria, or were prescribed the full dose, per labeled criteria.
Time frame: up to 12 months
The co-primary outcome for the retrospective analysis is 12-month adherence rates.
The pharmacy claims dataset will be used to obtain records of patient prescription fills, and the characteristics of those patients filling the prescriptions. The index event for each patient will be defined by when the second NVAF claim was filed. The dose will be initially determined from the index prescription. Of those patients prescribed a DOAC, medication adherence rates will be examined. DOAC adherence, defined as the proportion of days covered ≥80%, is calculated by the number of days any anticoagulant is available divided by the number of days in the follow-up period. Twelve-month adherence rates will be stratified according to whether the patient received a dose reduction following labeled criteria, a dose reduction inconsistent with labeled criteria, or were prescribed the full dose, per labeled criteria.
Time frame: up to 12 months
Prevalence of under-dosing
Providers who contributed at least 25 NVAF patients on DOACs to the pharmacy claims dataset will be grouped into tertiles based on the frequency of under-dosing: high, intermediate, and low. We will examine the association of provider factors with the likelihood of under-dosing.
Time frame: up to 12 months
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Duke University