ClinicalTrials.gov
ClinicalTrials.gov Menu

Atrial Fibrillation Screening and Education Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03440762
Recruitment Status : Active, not recruiting
First Posted : February 21, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Heart Rhythm Society
Information provided by (Responsible Party):
Pamela J. McCabe, R.N., Ph.D., Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Behavioral: AF awareness education Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group pre-post educational intervention
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of a Community-Placed Atrial Fibrillation Screening and Education Program
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Feasibility-number enrolled [ Time Frame: 5 months ]
    number of participants enrolled

  2. Feasibility-time required for study procedure [ Time Frame: 5 months ]
    Number of minutes require to perform mobile ECG

  3. Participants' perception of the usefulness of the Learning Station activities [ Time Frame: 5 months ]
    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 :
  1. Change in knowledge attitude, and beliefs scores about AF self monitoring from baseline [ Time Frame: 5 months ]
    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.

  2. Number of cases of atrial fibrillation detected with portable ECG [ Time Frame: 5 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440762


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Heart Rhythm Society
Investigators
Principal Investigator: Pamela J McCabe Mayo Clinic

Responsible Party: Pamela J. McCabe, R.N., Ph.D., Nurse Scientist, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03440762     History of Changes
Other Study ID Numbers: 17-005031
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pamela J. McCabe, R.N., Ph.D., Mayo Clinic:
Screening
Education
AFib Awareness
Stroke prevention

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes