Health-related Quality of Life in Patients on Anticoagulants
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: DOAC or VKADrug: VKA
- Registration Number
- NCT03134911
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 535
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description anticoagulation controlled patients DOAC or VKA Treated with DOAC or VKA anticoagulation non controlled patients VKA Treated with VKA
- Primary Outcome Measures
Name Time Method Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire The study consisted of a single visit between April 2017 and January 2018 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.
- Secondary Outcome Measures
Name Time Method Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 Height of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 Weight of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 Kidney function of uncontrolled non-valvular atrial fibrillation (NVAF) patients measured by creatinine clearance is presented.
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 Age group, work status and life status of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis The study consisted of a single visit between April 2017 and January 2018 Age at diagnosis of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients 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 is presented.
Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 Percentage of patients with left ventricular ejection fraction (LVEF) depression (% of LVEF depression) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented qualitatively.
CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 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.
HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 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.
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories 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 are presented.
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories 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 are presented.
Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients The study consisted of a single visit between April 2017 and January 2018 Number of visits to the internal medicine specialist per year of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients 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 determined by the Rosendaal method (poor control \< 65%) or by the direct method (poor control \< 60%).
Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients 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 was calculated as the time from the start date of treatment to the date of the baseline visit.
Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment The study consisted of a single visit between April 2017 and January 2018 Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients received type VKA treatment is presented.
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant 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 at least one other concomitant diseases recorded in the medical history.
History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis The study consisted of a single visit between April 2017 and January 2018 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 Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day 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 was calculated on total patients who presented each of the diseases.
The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment 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 is presented.
Trial Locations
- Locations (39)
Hospital Universitario Príncipe de Asturias
🇪🇸Alcalá De Henares (Madrid), Spain
Hospital Público Virgen de los Lirios
🇪🇸Alcoy (Alicante), Spain
Hospital San Juan de Dios
🇪🇸Bormujos (Sevilla), Spain
Hospital General Universitario de Castellón
🇪🇸Castellón De La Plana (Castellón), Spain
Hospital Universitario de La Plana
🇪🇸Villarreal (Castellón), Spain
Hospital Universitario de Torrevieja
🇪🇸Torrrevieja (Alicante), Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital de La Princesa
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario de Móstoles
🇪🇸Móstoles (Madrid), Spain
Hospital Comarcal Francesc de Borja
🇪🇸Gandía (València), Spain
Hospital De Llíria (depende del Arnau de Vilanova)
🇪🇸Llíria (Valencia), Spain
Hospital Universitario Doce de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Infanta Sofia
🇪🇸San Sebastián De Los Reyes (Madrid), Spain
Hospital Lluis Alcanyis
🇪🇸Xàtiva (Valencia), Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital de Sagunto
🇪🇸Sagunto (Valencia), Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda (Madrid), Spain
Hospital Vega Baja
🇪🇸Orihuela (Alicante), Spain
Hospital Regional de Málaga (Carlos Haya)
🇪🇸Málaga, Spain
Hospita Universitario Fundación Alcorcón
🇪🇸Alcorcón (Madrid), Spain
HospitalUniversitario Príncipe de Asturias
🇪🇸Alcalá De Henares (Madrid), Spain
Hospital General Universitario de Elche
🇪🇸Elche (Alicante), Spain
Hospital Universitario de Fuenlabrada
🇪🇸Fuenlabrada (Madrid), Spain
Hospital Universitario Monteprincipe
🇪🇸Boadilla Del Monte (Madrid), Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Complejo Hospitalario Torrecárdenas
🇪🇸Almería, Spain
Hospital Universitario San Juan de Alicante
🇪🇸Alicante, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hopital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Costa del Sol
🇪🇸Marbella (Málaga), Spain
Complejo Hospitalario de Especialidades Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Rey Juan Carlos
🇪🇸Móstoles (Madrid), Spain
Hospital Virgen del Camino
🇪🇸Pamplona (Navarra), Spain
Hospital General de Requena
🇪🇸Requena (Valencia), Spain
Hospital Clínico Universitariio de Valencia
🇪🇸Valencia, Spain