Feasibility Testing of the Alert for Atrial Fibrillation Program

NCT ID: NCT01988974

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to determine the psychometric properties of the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS) and to generate critical, practical knowledge about the feasibility of conducting a randomized trial to test the effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of Atrial Fibrillation (AF).

Detailed Description

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The purpose of the proposed research is to evaluate the psychometric properties of the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS), which is an instrument designed to tailor the delivery of the Alert for Atrial Fibrillation program. The proposed research will also test the feasibility of studying the effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of AF in a larger, randomized trial. This research is significant, because current research suggests that treatment seeking for AF is hindered when people do not recognize symptoms that represent AF, attribute those symptoms to alternative causes, or do not believe symptoms are serious enough to require medical evaluation. Interventions tailored to modify patient-specific knowledge, attitudes, and beliefs that hinder early treatment-seeking are critically needed in order to improve early detection of AF. The long term goal of this research is to improve health outcomes of those at risk for developing AF.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Alert for AF Program

1\) participation in the Alert for Atrial Fibrillation program ) .

Group Type EXPERIMENTAL

Alert for Atrial Fibrillation Program

Intervention Type BEHAVIORAL

Participants' baseline knowledge of AF symptoms, and attitudes and beliefs about AF will be assessed using the KABAFS, and patients will receive cognitive-behavioral training directed toward survey responses associated with delay of treatment. Training will incorporate the content developed by the American College of Cardiology Foundation (ACCF), and participants will receive education about how to recognize an irregular pulse, and how to record the pulse rhythm in a daily log. The PI/RN coordinator will review the completed KABAFS to assess knowledge deficits, and identify attitudes and beliefs about AF that may hinder early treatment-seeking.

Attention control condition

2\) participation in the healthy sleep program

Group Type ACTIVE_COMPARATOR

Healthy Sleep

Intervention Type BEHAVIORAL

Participants will receive a 45 minute face to face instruction about sleep hygiene

Interventions

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Alert for Atrial Fibrillation Program

Participants' baseline knowledge of AF symptoms, and attitudes and beliefs about AF will be assessed using the KABAFS, and patients will receive cognitive-behavioral training directed toward survey responses associated with delay of treatment. Training will incorporate the content developed by the American College of Cardiology Foundation (ACCF), and participants will receive education about how to recognize an irregular pulse, and how to record the pulse rhythm in a daily log. The PI/RN coordinator will review the completed KABAFS to assess knowledge deficits, and identify attitudes and beliefs about AF that may hinder early treatment-seeking.

Intervention Type BEHAVIORAL

Healthy Sleep

Participants will receive a 45 minute face to face instruction about sleep hygiene

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 65 years of age or older
* Under the care of providers from the Department of Medicine
* English-speaking
* Community dwelling,
* Have access to and ability to communicate via a telephone
* Have one or more risks for developing AF
* Not be diagnosed with AF

Exclusion Criteria

* Documented cognitive impairment
* Uncompensated hearing or visual deficits
* Scheduled for surgery or have undergone a surgical procedure in the last 30 days,
* Undergoing active treatment for a malignancy
* Receiving hospice care will be excluded
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Pamela J. McCabe, R.N., Ph.D.

Assistant Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela J McCabe, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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13-007768

Identifier Type: -

Identifier Source: org_study_id

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