Feasibility Testing of the Alert for Atrial Fibrillation Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Pamela J. McCabe, R.N., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01988974
First received: November 14, 2013
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Atrial Fibrillation
Behavioral: Alert for Atrial Fibrillation Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility Testing of the Alert for Atrial Fibrillation Program

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Changes on the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey [ Time Frame: Baseline, One Month, Two Months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: November 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alert for AF Program
Participants will participate in the Alert for Atrial Fibrillation program.
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988974

Contacts
Contact: Pamela J. McCabe, PhD, RN 507-293-1515 mccabe.pamela2@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Pamela McCabe, PhD, RN    507-293-1515    mccabe.pamela2@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Pamela J McCabe, PhD, RN Mayo Clinic
  More Information

No publications provided

Responsible Party: Pamela J. McCabe, R.N., Ph.D., Assistant Professor of Nursing, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01988974     History of Changes
Other Study ID Numbers: 13-007768
Study First Received: November 14, 2013
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014