- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03127085
A.Fib Emergency Department Study Atrial Fibrillation
Patient Specific Reasons for Attending the Emergency Department in the Setting of a Background History of Atrial Fibrillation
Study Overview
Status
Conditions
Detailed Description
This study is a multi-centre, multi-provincial, patient survey using mixed methods. 778 patients will be enrolled from 9 centres in 3 provinces from academic, urban, and rural centres to achieve geographical and health system heterogeneity. The planned duration of the entire study (enrollment through follow-up) is approximately 12 months. Patients presenting to the ED with a primary diagnosis of AF and with a prior diagnosis of established AF will be approached to participate. Each centre will be responsible for obtaining local consent. Data will be stored confidentially and securely at the coordinating centre (Queens University, Kingston, Ontario).
Patients who meet the inclusion criteria will be invited to take part at the time of presentation to the ED or after their ED visit. For all enrolled patients, one follow up telephone call will be made within one to four weeks of the ED visit by a social scientist with specialised training in questionnaires based in Queens University, Kingston, Ontario.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre - Kingston General Hospital Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female ≥ 18 years of age
- Atrial fibrillation is the primary reason for ED visit (documented by 12-lead ECG or Holter rhythm strip by a member of the healthcare team providing care to the patient).
- Patients with an established history of AF (prior diagnosis with ECG / rhythm strip evidence of AF)
- Patient must be literate in English
- Patient must provide informed consent
Exclusion Criteria:
- Male or female < 18 years of age
- Non-English speaking
- unable and/or unwilling to consent
- Acute coronary syndrome (ischemic chest pain, ST changes, + troponin [mild troponin elevation alone does not exclude the patient])
- Cardiogenic shock or class IV congestive heart failure at the time of visit
- Enrolled in a cardiovascular drug or device research study
- New onset atrial fibrillation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient decisions and perceptions before an after attending the emergency department with symptoms which may be related to atrial fibrillation
Time Frame: All surveys will occur within a time period of less than or equal to four weeks post emergency department visit
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A detailed telephone survey will be performed in which patients with a known history of atrial fibrillation and symptoms which they feel are related to their diagnosis and who are agreeable to take part in the study will be called by a social scientist.
They will be asked a series of questions and their responses will be recorded either on a Likert scale (symptom severity, satisfaction with treatment, quality of life) or as qualitative data (exact symptoms, fears and concerns relating to their underlying diagnosis)
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All surveys will occur within a time period of less than or equal to four weeks post emergency department visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benedict Glover, MD, Queen's University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF ED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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