Evaluating Quality of Life of AF Patients Following a Bleed

NCT04921176 | Completed

• 1 other identifier: 279646
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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

Keywords

Quality of Life; Bleed events; Patient Reported Outcome Measure; Anticoagulation

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Observe differences in QoL by type of bleed as measured by clinical classification of minor and major bleeds using BARC scale.

  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.

  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.

  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.

  One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Patients with active cancer
• Patients unable to consent for themselves
• Patient on concomitant antiplatelet therapy

Sponsors & Collaborators

• Swansea University: lead
• Bristol-Myers Squibb: collaborator
• Pfizer: collaborator

Study Sites (3)

Arrhythmia Alliance

Oxford, England, OX7 5SR, United Kingdom

Location

Morriston Hospital

Swansea, West Glamorgan, SA6 6NL, United Kingdom

Location

Swansea City GP Cluster

Swansea, West Glamorgan, United Kingdom

Location

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Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Hayley Hutchings

  Swansea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: June 10, 2021
• Study Start: December 22, 2020
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: April 28, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)