Health-related Quality of Life in Patients on Anticoagulants

Study Overview
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Brief Summary
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The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. It will be conducted in Departments of Internal Medicine from approximately 50 centers in Spain. It consists of an only visit that will coincide with one of those performed by the patients as part of routine follow-up of their disease. 500 patients seen in internal medicine are planned to be included in the study

Official Title
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Non-Interventional, Cross-sectional Study to Describe Health-related Quality of Life Among Controlled and Uncontrolled Patients With Nonvalvular Atrial Fibrillation on Anticoagulants. RE-QUOL Study.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: DOAC or VKA
* Drug: VKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is willing and provides written informed consent to participate in this study. The patient is at least 18 years of age The patient has a diagnosis of non-valvular atrial fibrillation The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years. If treated with VKA, availability of % Time in Therapeutic Range (TTR) in past analytical records or enough amount of International Normalized Ratio (INR) measures to calculate it. Exclusion Criteria: Current participation in any clinical trial of a drug or device Contraindication to the use of DOAC or VKA as described in the Summary of Product Characteristics (SmPC).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| anticoagulation controlled patients<br>Treated with DOAC or VKA | Drug: DOAC or VKA<br>* 6 months - 2 years<br>|
| anticoagulation non controlled patients<br>Treated with VKA | Drug: VKA<br>* 6 months - 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire | Sawicki questionnaire includes 32 items grouped in 5 dimensions: 1) general treatment satisfaction, 2) self-efficacy, 3) strained social network, 4) daily hassles and 5) distress. Patients estimated the impact of each item on their self-perceived treatment-related QoL on a scale of 1 (total disagreement) to 6 (total agreement). Response options for each question were: 1=not at all, 2=very little, 3=a little, 4=somewhat, 5=a lot, 6=very much. High scores in general treatment satisfaction and self-efficacy dimensions indicate high perceived HRQoL. Low scores in the strained social network, daily hassles and distress dimensions indicate high perceived HRQoL. The summary score for each dimension was calculated by dividing the total score of the sum of the items that comprise each dimension into the number of items included in that dimension. For the general treatment satisfaction dimension, the scores of individual questions have to be inverted first to calculate the dimension score. | The study consisted of a single visit between April 2017 and January 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Age group, work status and life status of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Height of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Weight of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Kidney function of uncontrolled non-valvular atrial fibrillation (NVAF) patients measured by creatinine clearance is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis | Analysis of data regarding the specific NVAF profile of uncontrolled patients indicated that the average (± SD) time since diagnosis (calculated as the time from the date of diagnosis to the date of the baseline visit). | The study consisted of a single visit between April 2017 and January 2018 | 
| History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis | Age at diagnosis of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Left ventricular ejection fraction (LVEF) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Percentage of patients with left ventricular ejection fraction (LVEF) depression (% of LVEF depression) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented qualitatively. | The study consisted of a single visit between April 2017 and January 2018 | 
| CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. | The study consisted of a single visit between April 2017 and January 2018 | 
| HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. | The study consisted of a single visit between April 2017 and January 2018 | 
| Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories | Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of thromboembolic events by categories are presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories | Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of haemorrhagic events by categories are presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Number of visits to the internal medicine specialist per year of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Therapeutic time in range (TTR%) of uncontrolled non-valvular atrial fibrillation (NVAF) patients determined by the Rosendaal method (poor control < 65%) or by the direct method (poor control < 60%). | The study consisted of a single visit between April 2017 and January 2018 | 
| Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients | Time since treatment initiation of uncontrolled non-valvular atrial fibrillation (NVAF) patients was calculated as the time from the start date of treatment to the date of the baseline visit. | The study consisted of a single visit between April 2017 and January 2018 | 
| Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment | Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients received type VKA treatment is presented. | The study consisted of a single visit between April 2017 and January 2018 | 
| The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases | The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with at least one other concomitant diseases recorded in the medical history. | The study consisted of a single visit between April 2017 and January 2018 | 
| The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day | The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with active concomitant diseases on visit day. The percentage was calculated on total patients who presented each of the diseases. | The study consisted of a single visit between April 2017 and January 2018 | 
| The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment | The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with concomitant treatment is presented. | The study consisted of a single visit between April 2017 and January 2018 |