Clinical trial NCT03440762: Atrial Fibrillation Screening and Education Study
Official title: Evaluation of a Community-Placed Atrial Fibrillation Screening and Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Screening
Education
AFib Awareness
Stroke prevention
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Heart Rhythm Society
First posted: 2018-02-22
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pre-post educational intervention
Primary purpose: SCREENING

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Feasibility-number enrolled
timeFrame: 5 months
measure: Feasibility-time required for study procedure
timeFrame: 5 months
measure: Participants' perception of the usefulness of the Learning Station activities
timeFrame: 5 months
Secondary outcomes:
measure: Change in knowledge attitude, and beliefs scores about AF self monitoring from baseline
timeFrame: 5 months
measure: Number of cases of atrial fibrillation detected with portable ECG
timeFrame: 5 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Pamela J McCabe
role: PRINCIPAL_INVESTIGATOR
References: