Atrial Fibrillation Patient Preference Study
PRiSMA-AF
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study.
1 other identifier
observational
382
1 country
1
Brief Summary
The main research question of this patient survey is to assess AF patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban). VKA (Waran®) will be compared to Rivaroxaban.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedStudy Start
First participant enrolled
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2017
CompletedFebruary 7, 2018
February 1, 2018
12 months
October 16, 2015
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Frequency of intake (once/twice daily)
up to 4 weeks after enrollment of patient
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Need of International normalized ratio (INR) monitoring/dose adjustment (yes/no)
up to 4 weeks after enrollment of patient
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Need of bridging (yes/no)
up to 4 weeks after enrollment of patient
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Interactions with food/drugs (yes/no)
up to 4 weeks after enrollment of patient
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Distance to treating physician (1km or 50km).
up to 4 weeks after enrollment of patient
Secondary Outcomes (10)
Patient-related burden of treatment with anticoagulants measured by the Benefit and Burden Scale of the Anti-clot Treatment Scale (ACTS)
Baseline
Patient's quality of life measured using the SF-12 (interview version)
up to 4 weeks after enrollment of patient
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Age
Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Gender
Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: preferred Anticoagulation treatment (agent)
Baseline
- +5 more secondary outcomes
Study Arms (2)
VKA treatment of AF / Cohort 1
A sample of about 200 patients with non-valvular atrial fibrillation who are treated with VKAs for at least three months at date of study inclusion
NOAC treatment of AF / Cohort 2
A sample of about 200 patients with non-valvular atrial fibrillation who are treated with NOACs for at least three months at date of study inclusion
Interventions
VKA have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
Eligibility Criteria
Patients in primary care / internal medicine specialist practices or cardiology outpatient clinics in Sweden.
You may qualify if:
- Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
- Generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in Swedish language.
- Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke \& systemic embolism for at least the previous 3 months.
- Continuous anticoagulation with a VKA for prevention of Stroke \& systemic embolism for at least the previous 3 months.
You may not qualify if:
- Participation in another
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Multiple Locations, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2015
First Posted
November 23, 2015
Study Start
February 2, 2016
Primary Completion
January 26, 2017
Study Completion
February 16, 2017
Last Updated
February 7, 2018
Record last verified: 2018-02