Clinical trial NCT03134911: Health-related Quality of Life in Patients on Anticoagulants
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 535
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 diagnosed of non valvular atrial fibrillation and prescribed DOACs or VKA, who are seen in internal medicine from hospitals of 3 Autonomous Communities in Spain (Madrid, Comunidad Valenciana, Andalucía)

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


Eligibility criteria: 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).

Primary outcomes:
measure: Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
timeFrame: The study consisted of a single visit between April 2017 and January 2018
Secondary outcomes:
measure: Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day
timeFrame: The study consisted of a single visit between April 2017 and January 2018
measure: The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment
timeFrame: The study consisted of a single visit between April 2017 and January 2018
Other outcomes:
Locations:
city: Alcalá De Henares (Madrid)
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Alcalá De Henares (Madrid)
country: Spain
facility: HospitalUniversitario Príncipe de Asturias
city: Alcorcón (Madrid)
country: Spain
facility: Hospita Universitario Fundación Alcorcón
city: Alcoy (Alicante)
country: Spain
facility: Hospital Público Virgen de los Lirios
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: Almería
country: Spain
facility: Complejo Hospitalario Torrecárdenas
city: Boadilla Del Monte (Madrid)
country: Spain
facility: Hospital Universitario Monteprincipe
city: Bormujos (Sevilla)
country: Spain
facility: Hospital San Juan de Dios
city: Castellón De La Plana (Castellón)
country: Spain
facility: Hospital General Universitario de Castellón
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Elche (Alicante)
country: Spain
facility: Hospital General Universitario de Elche
city: Fuenlabrada (Madrid)
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Gandía (València)
country: Spain
facility: Hospital Comarcal Francesc de Borja
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Llíria (Valencia)
country: Spain
facility: Hospital De Llíria (depende del Arnau de Vilanova)
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hopital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
city: Majadahonda (Madrid)
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Marbella (Málaga)
country: Spain
facility: Hospital Costa del Sol
city: Málaga
country: Spain
facility: Complejo Hospitalario de Especialidades Virgen de la Victoria
city: Málaga
country: Spain
facility: Hospital Regional de Málaga (Carlos Haya)
city: Móstoles (Madrid)
country: Spain
facility: Hospital Universitario Rey Juan Carlos
city: Móstoles (Madrid)
country: Spain
facility: Hospital Universitario de Móstoles
city: Orihuela (Alicante)
country: Spain
facility: Hospital Vega Baja
city: Pamplona (Navarra)
country: Spain
facility: Hospital Virgen del Camino
city: Requena (Valencia)
country: Spain
facility: Hospital General de Requena
city: Sagunto (Valencia)
country: Spain
facility: Hospital de Sagunto
city: San Sebastián De Los Reyes (Madrid)
country: Spain
facility: Hospital Universitario Infanta Sofia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Torrrevieja (Alicante)
country: Spain
facility: Hospital Universitario de Torrevieja
city: Valencia
country: Spain
facility: Hospital Clínico Universitariio de Valencia
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Villarreal (Castellón)
country: Spain
facility: Hospital Universitario de La Plana
city: Xàtiva (Valencia)
country: Spain
facility: Hospital Lluis Alcanyis
Study officials:
affiliation: mireia.canals@boehringer-ingelheim.com
name: Mireia Canals, +34607550925
role: STUDY_CHAIR
References: