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

January 21, 2019 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Sofia
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The study consisted of a single visit between April 2017 and January 2018

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
The study consisted of a single visit between April 2017 and January 2018
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.
The study consisted of a single visit between April 2017 and January 2018
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.
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
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.
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
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.
The study consisted of a single visit between April 2017 and January 2018
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).
The study consisted of a single visit between April 2017 and January 2018
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.
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
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.
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
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.
The study consisted of a single visit between April 2017 and January 2018
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.
The study consisted of a single visit between April 2017 and January 2018
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.
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
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.
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
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.
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
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.
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
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%).
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 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.
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
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.
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
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.
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
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.
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
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.
The study consisted of a single visit between April 2017 and January 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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