Atrial Fibrillation Screening and Education Study

Mayo Clinic

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Behavioral: AF awareness education

Study type: Interventional

Funder types: Other

Identifiers

NCT03440762

17-005031

Details and patient eligibility

About

The purpose of this study is to evaluate the outcomes of a community placed atrial fibrillation (AF) screening and education program

Full description

Background/significance: Atrial fibrillation (AF) is a global epidemic that accounts for 15%-20% of 795,000 strokes occurring annually in the US, at a cost of $3.2 billion per year. Atrial fibrillation-related stroke will rise with the aging population and places enormous strain on healthcare resources and quality of life; yet they are highly preventable, by early detection of AF. Timely treatment reduces AF-related stroke risk by 68%, yet treatment is often delayed because people may not recognize the symptoms of AF or may be asymptomatic. Given the number of people at risk for development of AF and the dire consequences of untreated AF, efforts to promote early detection of AF through proactive screening of older adults at risk for AF have been successfully undertaken in Europe and Australia. However, little is known about the outcomes of conducting programs to screen for and educate people about AF in community settings in the US.

Purpose: The purpose of this descriptive pragmatic study to evaluate the outcomes of a community placed AF screening and education program. Primary outcomes include feasibility, number of participants who screen positive for AF, and changes in participants' Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Self-Monitoring (KABAF-SM) scores from baseline to two-weeks after enrollment.

Methods: Up to 250-participants who have at least two risk factors for developing AF and have no previous diagnosis of AF will be recruited from Midwest community settings and will be screened for AF using a mobile ECG recorder and will receive written information sheet about AF. A portion (up to 125) of those 250 participants will be invited to complete the KABAF-SM at baseline and 2-weeks after enrollment. Participants will have the option to participate in a variety of AF educational activities to reinforce and enhance the written information. Participants will be surveyed about their perceptions of the educational program after the screening and participating in the educational activities.

Evaluation methods: Descriptive statistics will be used to analyze feasibility (enrollment numbers, participants perception of the value of the educational activities, time required for study procedures,and AF detection.T-tests will be used to test for differences between KABAF-SM baseline and two-week scores for those who completed the KABAF-SM.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion :

Any two of the following:

• Hypertension
• Diabetes
• Sleep apnea
• Obesity
• Age > 75 years
• Peripheral arterial disease
• Female

Exclusion :

• Previous diagnosis of atrial fibrillation or atrial flutter
• Uncompensated visual impairment
• Uncompensated hearing impairment
• Inability to communicate verbally in English

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

AF awareness education

Other group

Description:

AF awareness education face to face

Treatment:

Behavioral: AF awareness education