Evaluating Quality of Life of AF Patients Following a Bleed

Atrial Fibrillation Clinical Trial

— EQUAL-AF  

Official title:

Evaluating Quality of Life of AF Patients Following a Bleed

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04921176
• Other study ID #: 279646
• Status: Completed
• Start date: December 22, 2020
• Est. completion date: March 9, 2022

Study information

• Verified date: September 2022
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

EQUAL-AF is an observational feasibility study which will determine if there is a long-term effect of bleeding for patients diagnosed with AF, who are taking anticoagulants. The investigators will use three validated questionnaires/PROMs (AFEQT, EQ5D-3L, and PACT-Q) to gather data from a patient perspective. Patients will complete all questionnaires no more than 4 weeks following a bleed and a second time 3 months later. As this study tests feasibility, progression criteria will apply. The primary objective is to assess recruitment success to ensure that the patient population is accessible and willing to engage with the research team. Additionally, the investigators will look to identify the need for a specific bleeding PROM which will assess long-term quality of life impact for patients experiencing bleeds while anticoagulated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Adult patients (>= 18 years old)

• Patients who can understand all study information and literature to provide fully informed consent

• Atrial fibrillation (AF) as the primary diagnosis

• Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment

• Receiving oral anticoagulation therapy for AF

Exclusion Criteria:

• Pregnant women

• Patients with active cancer

• Patients unable to consent for themselves

• Patient on concomitant antiplatelet therapy

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United Kingdom	Arrhythmia Alliance	Oxford	England
United Kingdom	Morriston Hospital	Swansea	West Glamorgan
United Kingdom	Swansea City GP Cluster	Swansea	West Glamorgan

Sponsors (3)

Lead Sponsor	Collaborator
Swansea University	Bristol-Myers Squibb, Pfizer

Country where clinical trial is conducted

United Kingdom, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the feasibility of identifying and recruiting patients with both minor and major bleeds as a result of anticoagulant treatment for AF associated events	Recruitment of a minimum of 50 eligible patients onto the study	Following 6 months recruitment window
Primary	Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score	Patient quality of life in both primary and secondary care settings as measured by EQ-5D-	Within 4 weeks following bleed
Primary	Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score	Patient quality of life in both primary and secondary care settings as measured by EQ-5D-	3 months following first completion of study survey
Primary	Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT)	Patient quality of life in both primary and secondary care settings as measured by Atrial	Within 4 weeks following bleed
Primary	Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT)	Patient quality of life in both primary and secondary care settings as measured by Atrial	3 months following first completion of study survey
Primary	Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q)	Patient quality of life in both primary and secondary care settings as measured by	Within 4 weeks following bleed
Primary	Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q)	Patient quality of life in both primary and secondary care settings as measured by	3 months following first completion of study survey
Secondary	Observe differences in QoL by type of bleed as measured by clinical classification of minor and major bleeds using BARC scale.	A small number of additional relevant questions will be asked of the patient, regarding when the bleed occurred, the nature of the bleed and their current treatment.	One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
Secondary	Identifying the treatment received and the nature of the bleed experienced by capturing type of anticoagulant combined with bleed details from each participant.	Identifying the treatment received and the nature of the bleed experienced by capturing	One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
Secondary	Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews.	Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews.	Following completion of both 4 week and 3 month timepoint.
Secondary	Appropriateness of three chosen PROMs (EQ5D, AFEQT and PACT-Q, part 2) in capturing QoL data for patients who have experienced a bleed while anticoagulated as measured by responses to suitability questions within the participant survey.	Additional questions to evaluate appropriateness of chosen PROMs in capturing Quality of Life issues for patients diagnosed with AF who are anticoagulated	One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.

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