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Atrial Fibrillation Screening and Education Study

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AF awareness education
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atrial Fibrillation focused on measuring Screening, Education, AFib Awareness, Stroke prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AF awareness education

Arm Description

AF awareness education face to face

Outcomes

Primary Outcome Measures

Feasibility-number enrolled
number of participants enrolled
Feasibility-time required for study procedure
Number of minutes require to perform mobile ECG
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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
February 1, 2018
Last Updated
September 11, 2020
Sponsor
Mayo Clinic
Collaborators
Heart Rhythm Society
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1. Study Identification

Unique Protocol Identification Number
NCT03440762
Brief Title
Atrial Fibrillation Screening and Education Study
Official Title
Evaluation of a Community-Placed Atrial Fibrillation Screening and Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
August 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Heart Rhythm Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Screening, Education, AFib Awareness, Stroke prevention

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group pre-post educational intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AF awareness education
Arm Type
Other
Arm Description
AF awareness education face to face
Intervention Type
Behavioral
Intervention Name(s)
AF awareness education
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility-number enrolled
Description
number of participants enrolled
Time Frame
5 months
Title
Feasibility-time required for study procedure
Description
Number of minutes require to perform mobile ECG
Time Frame
5 months
Title
Participants' perception of the usefulness of the Learning Station activities
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Change in knowledge attitude, and beliefs scores about AF self monitoring from baseline
Description
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.
Time Frame
5 months
Title
Number of cases of atrial fibrillation detected with portable ECG
Description
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
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela J McCabe
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Atrial Fibrillation Screening and Education Study

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