Skip to main content
OpenTrials
Completed

NCT Number: NCT03134911

Health-related Quality of Life in Patients on Anticoagulants

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Príncipe de Asturias, Alcalá de Henares (Madrid), Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DOAC or VKA

Drug

6 months - 2 years

VKA

Drug

6 months - 2 years

Primary outcomes

  1. Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire

    Time frame: 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 outcomes

  1. Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    Time frame: 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.

  2. Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    Time frame: The study consisted of a single visit between April 2017 and January 2018

    Height of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.

  3. Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    Time frame: The study consisted of a single visit between April 2017 and January 2018

    Weight of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.

  4. Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    Time frame: The study consisted of a single visit between April 2017 and January 2018

    BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.

  5. Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    Time frame: 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.

  6. History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis

    Time frame: 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).

  7. History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis

    Time frame: 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.

  8. Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    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 is presented.

  9. Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    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 LVEF depression) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented qualitatively.

  10. CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    Time frame: 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.

  11. HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    Time frame: 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.

  12. Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories

    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 are presented.

  13. Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories

    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 are presented.

  14. Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    Time frame: 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.

  15. Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    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 determined by the Rosendaal method (poor control < 65%) or by the direct method (poor control < 60%).

  16. Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients

    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 was calculated as the time from the start date of treatment to the date of the baseline visit.

  17. Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment

    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 VKA treatment is presented.

  18. The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant 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 at least one other concomitant diseases recorded in the medical history.

  19. The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day

    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 was calculated on total patients who presented each of the diseases.

  20. The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment

    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 is presented.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Acronym: RE-QUOL

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 1, 2017
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.