NCT02607371CompletedNot Applicable
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 198
- Primary Endpoint
- AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview
Study Overview
Brief Summary
The main research question of this patient survey is to assess AF (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).
VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.
Detailed Description
The objective of this study is to investigate the following research questions in a cross-sectional survey of German-speaking Swiss AF patients being treated either with a VKA or with a NOAC:
- Which attributes of a medication to prevent stroke do AF patients view as important?
- Do AF patients have a preference regarding the attributes of the medication options VKA or NOAC and, in case of NOACs, with regards to rivaroxaban attributes?
- Are there subgroups of AF patients whose preference for one of the medication options appears above or below average?
- What is the quality of life of Swiss German-speaking AF patients? Are there subgroups with differences in their quality of life (for example: subgroups of patients with different CHA2DS2-VASc scores)?
- Which burden do German-speaking Swiss AF patients experience in association with their anticoagulation therapy? Are there differences in the burden of treatment (ACTS) between patients treated with VKA or with NOACs?
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria for AF patients in both the NOAC and the VKA groups:
- •Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
- •Age of at least 18 years at time of study inclusion,
- •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 German language.
- •Additional inclusion criterion for Group 1 (NOAC):
- •Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke & systemic embolism for at least the previous 3 months.
- •Additional inclusion criterion for Group 2 (VKA):
- •Continuous anticoagulation with a VKA for prevention of Stroke & systemic embolism for at least the previous 3 months.
Exclusion Criteria
- •Exclusion criteria for both groups:
- •Participation in another study (clinical intervention / observational) within the 3 months prior to enrollment,
- •Interruption of VKA/NOAC therapy of more than 2 weeks (bridging) within the prior 3 months or planned bridging in 4 weeks after study inclusion.
Outcomes
Primary Outcomes
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview
Time Frame: up to 4 weeks
* DCE is based on the following attributes /attribute levels: * Frequency of intake (once/twice daily), * Need of INR monitoring/dose adjustment (yes/no), * Need of bridging (yes/no), * Interactions with food/drugs (yes/no), * Distance to treating physician (1km or 15km).
Secondary Outcomes
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score(up to 4 weeks)
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Gender(up to 4 weeks)
- Health-related quality of life measured by the SF-12 questionnaire(up to 4 weeks)
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA(up to 4 weeks)
- Burden associated with anticoagulation treatment measured by the questionnaire ACTS(Baseline)
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)(up to 4 weeks)
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: preferred anticoagulation treatment (agent)(up to 4 weeks)
- Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Age(up to 4 weeks)
Investigators
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