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
Study Type
OBSERVATIONAL
Enrollment
535
6 months - 2 years
6 months - 2 years
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.
Time frame: The study consisted of a single visit between April 2017 and January 2018
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.
Time frame: 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.
Time frame: 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.
Time frame: The study consisted of a single visit between April 2017 and January 2018
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Hospital Universitario Príncipe de Asturias
Alcalá de Henares (Madrid), Spain
HospitalUniversitario Príncipe de Asturias
Alcalá de Henares (Madrid), Spain
Hospita Universitario Fundación Alcorcón
Alcorcón (Madrid), Spain
Hospital Público Virgen de los Lirios
Alcoy (Alicante), Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitario San Juan de Alicante
Alicante, Spain
Complejo Hospitalario Torrecárdenas
Almería, Spain
Hospital Universitario Monteprincipe
Boadilla Del Monte (Madrid), Spain
Hospital San Juan de Dios
Bormujos (Sevilla), Spain
Hospital General Universitario de Castellón
Castellón de La Plana (Castellón), Spain
...and 29 more locations
Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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%).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The study consisted of a single visit between April 2017 and January 2018