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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 535
- 试验地点
- 39
- 主要终点
- Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
anticoagulation controlled patients
Treated with DOAC or VKA
干预措施: DOAC or VKA (Drug)
anticoagulation non controlled patients
Treated with VKA
干预措施: VKA (Drug)
结局指标
主要结局
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire
时间窗: 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.
次要结局
- 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)
- Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients(The study consisted of a single visit between April 2017 and January 2018)
- CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients(The study consisted of a single visit between April 2017 and January 2018)
- History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis(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(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(The study consisted of a single visit between April 2017 and January 2018)
- HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients(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(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(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(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(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(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(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 study consisted of a single visit between April 2017 and January 2018)
- History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis(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 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 study consisted of a single visit between April 2017 and January 2018)