Health-related Quality of Life in Patients on Anticoagulants (RE-QUOL)
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| ClinicalTrials.gov Identifier: NCT03134911 |
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Recruitment Status :
Completed
First Posted : May 1, 2017
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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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
| Condition or disease | Intervention/treatment |
|---|---|
| Atrial Fibrillation | Drug: DOAC or VKA Drug: VKA |
| Study Type : | Observational |
| Actual Enrollment : | 535 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| 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. |
| Actual Study Start Date : | April 24, 2017 |
| Actual Primary Completion Date : | January 31, 2018 |
| Actual Study Completion Date : | January 31, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial atrial fibrillation
| Group/Cohort | Intervention/treatment |
|---|---|
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anticoagulation controlled patients
Treated with DOAC or VKA
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Drug: DOAC or VKA
6 months - 2 years |
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anticoagulation non controlled patients
Treated with VKA
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Drug: VKA
6 months - 2 years |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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%).
- 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.
- 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 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 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 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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)
Criteria
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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134911
Locations
Show 39 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Mireia Canals, +34607550925 | mireia.canals@boehringer-ingelheim.com |
Study Documents (Full-Text)
Documents provided by Boehringer Ingelheim:
Documents provided by Boehringer Ingelheim:
Study Protocol [PDF] January 5, 2017
Statistical Analysis Plan [PDF] December 11, 2017
Additional Information:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT03134911 |
| Other Study ID Numbers: |
1160-0280 |
| First Posted: | May 1, 2017 Key Record Dates |
| Results First Posted: | April 18, 2019 |
| Last Update Posted: | April 18, 2019 |
| Last Verified: | January 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |