Evaluating Quality of Life of AF Patients Following a Bleed

NCT ID: NCT04921176

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2022-03-09

Brief 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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Swansea University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hayley Hutchings

Role: PRINCIPAL_INVESTIGATOR

Swansea University

Locations

Arrhythmia Alliance

Oxford, England, United Kingdom

Morriston Hospital

Swansea, West Glamorgan, United Kingdom

Swansea City GP Cluster

Swansea, West Glamorgan, United Kingdom

Countries

United Kingdom

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Provided Documents

Document Type: Study Protocol

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Related Links

http://hbr.org/2013/10/the-strategy-that-will-fix-health-care

Related Info

Other Identifiers

279646

Identifier Type: -

Identifier Source: org_study_id