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Completed

NCT Number: NCT04921176

Evaluating Quality of Life of AF Patients Following a Bleed

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrhythmia Alliance, Oxford, England, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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-

  3. 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-

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Collaborators

  • Bristol-Myers Squibb
  • Pfizer

Registry information

Acronym: EQUAL-AF

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2021
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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