Atrial FibrillationNCT03440762
Atrial Fibrillation Screening and Education Study
A study testing AF awareness education in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the outcomes of a community placed atrial fibrillation (AF) screening and education program Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- AF awareness education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2017to 27 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any two of the following:
- Hypertension
- Diabetes
- Sleep apnea
- Obesity
- Age > 75 years
- Peripheral arterial disease
- Female
Who cannot join
- Previous diagnosis of atrial fibrillation or atrial flutter
- Uncompensated visual impairment
- Uncompensated hearing impairment
- Inability to communicate verbally in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- AF awareness education
- Keywords
- Screening, Education, AFib Awareness, Stroke prevention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF awareness educationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| AF awareness education | Other | AF awareness education face to face Receives: Behavioral: AF awareness education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility-number enrolled
number of participants enrolled
Measured: 5 months
Feasibility-time required for study procedure
Number of minutes require to perform mobile ECG
Measured: 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.
Measured: 5 months
Secondary outcomes (2)
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.
Measured: 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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start16 Aug 2017
- Primary completion28 Feb 2018
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre-post educational intervention
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Rhythm Society
- Responsible party
- Principal investigator, Pamela J. McCabe, R.N., Ph.D., Mayo Clinic
- Investigators
- Pamela J McCabe, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440762
- Sponsor's protocol ID
- 17-005031
- Status last verified
- Sep 2020
- First submitted
- 1 Feb 2018
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Community-Placed Atrial Fibrillation Screening and Education Program
- ClinicalTrials.gov ID
- NCT03440762
- Acronym / sponsor ID
- 17-005031
- Conditions
- Atrial Fibrillation
- Keywords
- Screening, Education, AFib Awareness, Stroke prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Heart Rhythm Society
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre-post educational intervention
| Arm | Type | Receives |
|---|---|---|
| AF awareness education | Other | Behavioral: AF awareness educationAF awareness education face to face |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hypertension
- Diabetes
- Sleep apnea
- Obesity
- Age > 75 years
Key exclusion criteria (4 listed)
- Previous diagnosis of atrial fibrillation or atrial flutter
- Uncompensated visual impairment
- Uncompensated hearing impairment
- Inability to communicate verbally in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF awareness educationParticipants 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 | Behavioural | AF awareness education |
Primary outcome
Feasibility-number enrolled
Time frame: 5 months
number of participants enrolled
Feasibility-time required for study procedure
Time frame: 5 months
Number of minutes require to perform mobile ECG
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.
2 secondary outcomes
Change in knowledge attitude, and beliefs scores about AF self monitoring from baseline
Time frame: 5 months
Number of cases of atrial fibrillation detected with portable ECG
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingPhase 4
A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela J McCabe principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF awareness education in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility-number enrolled (time frame: 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.