Clinical trial NCT02611635: Atrial Fibrillation Patient Preference Study
Official title: AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: non-valvular Atrial Fibrillation
Patient treatment preference
NOAC
VKA
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in primary care / internal medicine specialist practices or cardiology outpatient clinics in Sweden.

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.

Detailed description: The objective of this study is to investigate the following research questions in a cross-sectional survey of Swedish 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 Swedish 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 Swedish 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?

Eligibility criteria: 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 Swedish 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

Primary outcomes:
measure: 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)
timeFrame: up to 4 weeks after enrollment of patient
measure: 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)
timeFrame: up to 4 weeks after enrollment of patient
measure: 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)
timeFrame: up to 4 weeks after enrollment of patient
measure: 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)
timeFrame: up to 4 weeks after enrollment of patient
measure: 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).
timeFrame: up to 4 weeks after enrollment of patient
Secondary outcomes:
measure: Patient-related burden of treatment with anticoagulants measured by the Benefit and Burden Scale of the Anti-clot Treatment Scale (ACTS)
timeFrame: Baseline
measure: Patient's quality of life measured using the SF-12 (interview version)
timeFrame: up to 4 weeks after enrollment of patient
measure: Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Age
timeFrame: Baseline
measure: Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Gender
timeFrame: Baseline
measure: Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: preferred Anticoagulation treatment (agent)
timeFrame: Baseline
measure: Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score
timeFrame: Baseline
measure: Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA
timeFrame: Baseline
measure: Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)
timeFrame: Baseline
measure: Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Lifestyle variables
timeFrame: Baseline
measure: Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Previous switch of anticoagulation treatment
timeFrame: Baseline
Other outcomes:
Locations:
city: Multiple Locations
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: