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.
1 other identifier
observational
535
1 country
39
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Shorter than P25 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2017
CompletedStudy Start
First participant enrolled
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedResults Posted
Study results publicly available
April 18, 2019
CompletedApril 18, 2019
January 1, 2019
9 months
March 1, 2017
January 21, 2019
January 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (20)
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
The study consisted of a single visit between April 2017 and January 2018
Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
The study consisted of a single visit between April 2017 and January 2018
Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients
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
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
The study consisted of a single visit between April 2017 and January 2018
- +15 more secondary outcomes
Study Arms (2)
anticoagulation controlled patients
Treated with DOAC or VKA
anticoagulation non controlled patients
Treated with VKA
Interventions
Eligibility Criteria
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)
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Hospital Universitario Príncipe de Asturias
Alcalá de Henares (Madrid), 28805, Spain
HospitalUniversitario Príncipe de Asturias
Alcalá de Henares (Madrid), 28805, Spain
Hospita Universitario Fundación Alcorcón
Alcorcón (Madrid), 28922, Spain
Hospital Público Virgen de los Lirios
Alcoy (Alicante), 03804, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitario San Juan de Alicante
Alicante, 03550, Spain
Complejo Hospitalario Torrecárdenas
Almería, 04009, Spain
Hospital Universitario Monteprincipe
Boadilla Del Monte (Madrid), 28660, Spain
Hospital San Juan de Dios
Bormujos (Sevilla), 41930, Spain
Hospital General Universitario de Castellón
Castellón de La Plana (Castellón), 12004, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital General Universitario de Elche
Elche (Alicante), 03203, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada (Madrid), 28942, Spain
Hospital Comarcal Francesc de Borja
Gandía (València), 46702, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
Hospital De Llíria (depende del Arnau de Vilanova)
Llíria (Valencia), 46160, Spain
Hospital de La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hopital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario Doce de Octubre
Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro
Majadahonda (Madrid), 28222, Spain
Hospital Costa del Sol
Marbella (Málaga), 29603, Spain
Complejo Hospitalario de Especialidades Virgen de la Victoria
Málaga, 29010, Spain
Hospital Regional de Málaga (Carlos Haya)
Málaga, 29010, Spain
Hospital Universitario Rey Juan Carlos
Móstoles (Madrid), 28933, Spain
Hospital Universitario de Móstoles
Móstoles (Madrid), 28935, Spain
Hospital Vega Baja
Orihuela (Alicante), 03314, Spain
Hospital Virgen del Camino
Pamplona (Navarra), 31008, Spain
Hospital General de Requena
Requena (Valencia), 46340, Spain
Hospital de Sagunto
Sagunto (Valencia), 46520, Spain
Hospital Universitario Infanta Sofia
San Sebastián de Los Reyes (Madrid), 28703, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario de Torrevieja
Torrrevieja (Alicante), 03186, Spain
Hospital Clínico Universitariio de Valencia
Valencia, 46010, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitario de La Plana
Villarreal (Castellón), 12540, Spain
Hospital Lluis Alcanyis
Xàtiva (Valencia), 46800, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Centre
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Mireia Canals, +34607550925
mireia.canals@boehringer-ingelheim.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2017
First Posted
May 1, 2017
Study Start
April 24, 2017
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
April 18, 2019
Results First Posted
April 18, 2019
Record last verified: 2019-01