Health-related Quality of Life in Patients on Anticoagulants

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03134911

Acronym

RE-QUOL

Enrollment

535

Registered

2017-05-01

Start date

2017-04-24

Completion date

2018-01-31

Last updated

2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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

Interventions

DRUGDOAC or VKA

6 months - 2 years

DRUGVKA

6 months - 2 years

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire	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

Measure	Time frame	Description
Height 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 is presented.
Weight 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 is presented.
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	BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
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	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	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	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	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	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	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.
Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients	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.
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 thromboembolic events by categories are presented.
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	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	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	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	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	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	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	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	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.
HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients	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.

Countries

Spain

Participant flow

Recruitment details

This was an observational, multicentre and cross-sectional study conducted in Departments of Internal Medicine from 47 sites in Spain. The patient received the same anticoagulant treatment for at least 6 months and no more than 2 years.

Pre-assignment details

Data were obtained from a single visit that coincided with one of those performed by the patients as part of routine follow-up of their disease, without interfering with usual clinical practice of the investigator. 535 patients were enrolled and 34 excluded from analysis due to being screening failure and not meeting inclusion/ exclusion criteria.

Participants by arm

Arm	Count
Uncontrolled Group Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group.	171
Controlled Group Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group.	330
Total	501

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Not meeting inclusion/exclusion criteria	3
Overall Study	Screen failure	31

Baseline characteristics

Characteristic	Controlled Group	Total	Uncontrolled Group
Age, Continuous	79.3 Years STANDARD_DEVIATION 8.8	79.7 Years STANDARD_DEVIATION 8.7	80.4 Years STANDARD_DEVIATION 8.7
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants	—
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	0 Participants	—
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants	—
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	330 Participants	501 Participants	171 Participants
Sex: Female, Male Female	152 Participants	247 Participants	95 Participants
Sex: Female, Male Male	178 Participants	254 Participants	76 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 171	0 / 69	0 / 261
other Total, other adverse events	0 / 171	0 / 69	0 / 261
serious Total, serious adverse events	0 / 171	0 / 69	1 / 261

Outcome results

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.