Feasibility Testing of the Alert for Atrial Fibrillation Program

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2015

Detailed Description

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.

Interventions

  • Behavioral: 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.
  • Behavioral: Healthy Sleep
    • Participants will receive a 45 minute face to face instruction about sleep hygiene

Arms, Groups and Cohorts

  • Experimental: Alert for AF Program
    • 1) participation in the Alert for Atrial Fibrillation program ) .
  • Active Comparator: Attention control condition
    • 2) participation in the healthy sleep program

Clinical Trial Outcome Measures

Primary Measures

  • Changes on the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey
    • Time Frame: Baseline, One Month, Two Months
    • The KABAFS assesses patient knowledge of Atrial Fibrillation (AF) and the belief factors associated with delay in seeking treatment for AF. Participants will be measured at baseline (before the intervention), and then at 1 and 2 months after the intervention to identify if participants’ knowledge and beliefs about treatment seeking have improved and continue to be improved from baseline as indicated by the KABAFS score.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pamela J. McCabe, R.N., Ph.D., Assistant Professor of Nursing – Mayo Clinic
  • Overall Official(s)
    • Pamela J McCabe, PhD, RN, Principal Investigator, Mayo Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.