Health-related Quality of Life in Patients on Anticoagulants

Atrial Fibrillation Clinical Trial

— RE-QUOL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134911
• Other study ID #: 1160-0280
• Status: Completed
• Start date: April 24, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: January 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• DOAC or VKA
6 months - 2 years
• VKA
6 months - 2 years

Locations

Country	Name	City	State
Spain	Hospital Universitario Príncipe de Asturias	Alcalá De Henares (Madrid)
Spain	HospitalUniversitario Príncipe de Asturias	Alcalá De Henares (Madrid)
Spain	Hospita Universitario Fundación Alcorcón	Alcorcón (Madrid)
Spain	Hospital Público Virgen de los Lirios	Alcoy (Alicante)
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario San Juan de Alicante	Alicante
Spain	Complejo Hospitalario Torrecárdenas	Almería
Spain	Hospital Universitario Monteprincipe	Boadilla Del Monte (Madrid)
Spain	Hospital San Juan de Dios	Bormujos (Sevilla)
Spain	Hospital General Universitario de Castellón	Castellón De La Plana (Castellón)
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital General Universitario de Elche	Elche (Alicante)
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada (Madrid)
Spain	Hospital Comarcal Francesc de Borja	Gandía (València)
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital De Llíria (depende del Arnau de Vilanova)	Llíria (Valencia)
Spain	Hopital Clinico San Carlos	Madrid
Spain	Hospital de La Princesa	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Doce de Octubre	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda (Madrid)
Spain	Complejo Hospitalario de Especialidades Virgen de la Victoria	Málaga
Spain	Hospital Regional de Málaga (Carlos Haya)	Málaga
Spain	Hospital Costa del Sol	Marbella (Málaga)
Spain	Hospital Universitario de Móstoles	Móstoles (Madrid)
Spain	Hospital Universitario Rey Juan Carlos	Móstoles (Madrid)
Spain	Hospital Vega Baja	Orihuela (Alicante)
Spain	Hospital Virgen del Camino	Pamplona (Navarra)
Spain	Hospital General de Requena	Requena (Valencia)
Spain	Hospital de Sagunto	Sagunto (Valencia)
Spain	Hospital Universitario Infanta Sofia	San Sebastián De Los Reyes (Madrid)
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario de Torrevieja	Torrrevieja (Alicante)
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Hospital Clínico Universitariio de Valencia	Valencia
Spain	Hospital Universitario de La Plana	Villarreal (Castellón)
Spain	Hospital Lluis Alcanyis	Xàtiva (Valencia)

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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