Atrial Fibrillation Screening and Education Study

Evaluation of a Community-Placed Atrial Fibrillation Screening and Education Program

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Behavioral: AF awareness education

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AF awareness education; AF awareness education face to face	Behavioral: AF awareness education; Participants will receive education about a description of AF, complications, recognition of signs and symptoms of AF, pulse taking, and how to recognize an irregular pulse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility-number enrolled	number of participants enrolled	5 months
Feasibility-time required for study procedure	Number of minutes require to perform mobile ECG	5 months
Participants' perception of the usefulness of the Learning Station activities	The outcome will be measured by the Participant Perception of Learning Station Activities survey. This survey is an investigator developed 9-item Survey that asks participants to rate how useful learning activities were to increase their knowledge about atrial fibrillation and to what extent their knowledge about atrial fibrillation has increased after participating in the Learning Station activities. Psychometric testing has not been performed on this survey.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge attitude, and beliefs scores about AF self monitoring from baseline	Knowledge, attitudes, beliefs about self-monitoring for AF signs and symptoms will be measured by the Knowledge Attitudes and Beliefs about Atrial Fibrillation Self-Monitoring (KABAF-SM) instrument.The KABAF-SM is a 40-item instrument that measures knowledge of AF symptoms (8 items yes/no response, score range 0-8); symptoms not related to AF (6 items yes/no response, score range 0-6); and Likert- responses items (strongly disagree-1 to strongly agree-4) for beliefs about the participant's risk for developing AF(5 items), seriousness of AF,(4 items) benefits (5 items), and barriers (5 items) to monitoring for signs and symptoms of AF. Total score range for the Likert items is 14-56. Perceived confidence is measured by 7 items, rated from 0-10 (score range, 0-70) for ability to self-monitor for signs and symptoms of AF. Higher scores reflect more knowledge and more accurate beliefs and positive attitudes toward self-monitoring.	5 months
Number of cases of atrial fibrillation detected with portable ECG	The Alive Cor portable ECG recorder will be used to detect atrial fibrillation. The device displays the participants rhythm as normal sinus, possible or probable atrial fibrillation, or unable to analyze	5 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Heart Rhythm Society
• Investigators: Principal Investigator: Pamela J McCabe, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): August 27, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Screening; Education; Stroke prevention; AFib Awareness
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 17-005031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No