NCT03440762

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2019

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

February 1, 2018

Last Update Submit

September 11, 2020

Conditions

Keywords

ScreeningEducationAFib AwarenessStroke prevention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in knowledge attitude, and beliefs scores about AF self monitoring from baseline

    5 months

  • Number of cases of atrial fibrillation detected with portable ECG

    5 months

Study Arms (1)

AF awareness education

OTHER

AF awareness education face to face

Behavioral: AF awareness education

Interventions

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

AF awareness education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pamela J McCabe

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Single group pre-post educational intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Scientist

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 22, 2018

Study Start

August 16, 2017

Primary Completion

February 28, 2018

Study Completion

August 27, 2019

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations