Health-related Quality of Life in Patients on Anticoagulants (RE-QUOL)

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.

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: DOAC or VKA; Drug: VKA

• Study Type: Observational
• Enrollment (Actual): 535

Contacts and Locations

Study Locations

• Spain
  • Alcalá De Henares (Madrid), Spain, 28805
    • Hospital Universitario Príncipe de Asturias
  • Alcalá De Henares (Madrid), Spain, 28805
    • HospitalUniversitario Príncipe de Asturias
  • Alcorcón (Madrid), Spain, 28922
    • Hospita Universitario Fundación Alcorcón
  • Alcoy (Alicante), Spain, 03804
    • Hospital Público Virgen de los Lirios
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Alicante, Spain, 03550
    • Hospital Universitario San Juan de Alicante
  • Almería, Spain, 04009
    • Complejo Hospitalario Torrecárdenas
  • Boadilla Del Monte (Madrid), Spain, 28660
    • Hospital Universitario Montepríncipe
  • Bormujos (Sevilla), Spain, 41930
    • Hospital San Juan de Dios
  • Castellón De La Plana (Castellón), Spain, 12004
    • Hospital General Universitario de Castellon
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía
  • Elche (Alicante), Spain, 03203
    • Hospital General Universitario de Elche
  • Fuenlabrada (Madrid), Spain, 28942
    • Hospital Universitario de Fuenlabrada
  • Gandía (València), Spain, 46702
    • Hospital Comarcal Francesc De Borja
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova
  • Llíria (Valencia), Spain, 46160
    • Hospital De Llíria (depende del Arnau de Vilanova)
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28006
    • Hospital de La Princesa
  • Madrid, Spain, 28041
    • Hospital Universitario Doce de Octubre
  • Madrid, Spain, 28040
    • Hopital Clinico San Carlos
  • Majadahonda (Madrid), Spain, 28222
    • Hospital Universitario Puerta de Hierro
  • Marbella (Málaga), Spain, 29603
    • Hospital Costa del Sol
  • Málaga, Spain, 29010
    • Complejo Hospitalario de Especialidades Virgen de la Victoria
  • Málaga, Spain, 29010
    • Hospital Regional de Málaga (Carlos Haya)
  • Móstoles (Madrid), Spain, 28933
    • Hospital Universitario Rey Juan Carlos
  • Móstoles (Madrid), Spain, 28935
    • Hospital Universitario de Móstoles
  • Orihuela (Alicante), Spain, 03314
    • Hospital Vega Baja
  • Pamplona (Navarra), Spain, 31008
    • Hospital Virgen del Camino
  • Requena (Valencia), Spain, 46340
    • Hospital General de Requena
  • Sagunto (Valencia), Spain, 46520
    • Hospital de Sagunto
  • San Sebastián De Los Reyes (Madrid), Spain, 28703
    • Hospital Universitario Infanta Sofía
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Torrrevieja (Alicante), Spain, 03186
    • Hospital Universitario de Torrevieja
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario de Valencia
  • Valencia, Spain, 46010
    • Hospital Clínico Universitariio de Valencia
  • Villarreal (Castellón), Spain, 12540
    • Hospital Universitario de La Plana
  • Xàtiva (Valencia), Spain, 46800
    • Hospital Lluis Alcanyis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
anticoagulation controlled patients; Treated with DOAC or VKA	Drug: DOAC or VKA; 6 months - 2 years
anticoagulation non controlled patients; Treated with VKA	Drug: VKA; 6 months - 2 years

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 1160-0280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No