Evaluating Quality of Life of AF Patients Following a Bleed (EQUAL-AF)

April 27, 2023 updated by: Swansea University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Oxford, England, United Kingdom, OX7 5SR
        • Arrhythmia Alliance
    • West Glamorgan
      • Swansea, West Glamorgan, United Kingdom, SA6 6NL
        • Morriston Hospital
      • Swansea, West Glamorgan, United Kingdom
        • Swansea City GP Cluster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18) who have AF are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 4 weeks prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria. Patients will be selected from the Swansea area only, who attend/have attended either anticoagulation clinics within the Swansea City Health Cluster, Morriston emergency department or have been admitted to wards at Morriston Hospital due to a bleed.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the feasibility of identifying and recruiting patients with both minor and major bleeds as a result of anticoagulant treatment for AF associated events
Time Frame: Following 6 months recruitment window
Recruitment of a minimum of 50 eligible patients onto the study
Following 6 months recruitment window
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score
Time Frame: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-
Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score
Time Frame: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-
3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT)
Time Frame: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by Atrial
Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT)
Time Frame: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by Atrial
3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q)
Time Frame: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by
Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q)
Time Frame: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by
3 months following first completion of study survey

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observe differences in QoL by type of bleed as measured by clinical classification of minor and major bleeds using BARC scale.
Time Frame: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
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.
Identifying the treatment received and the nature of the bleed experienced by capturing type of anticoagulant combined with bleed details from each participant.
Time Frame: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
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.
Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews.
Time Frame: Following completion of both 4 week and 3 month timepoint.
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.
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.
Time Frame: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swansea University

Collaborators

Bristol-Myers Squibb
Pfizer

Investigators

  • Principal Investigator: Hayley Hutchings, Swansea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 279646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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