We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility Testing of the Alert for Atrial Fibrillation Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01988974
First Posted: November 20, 2013
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pamela J. McCabe, R.N., Ph.D., Mayo Clinic
  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 Behavioral: Healthy Sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Pamela J. McCabe, R.N., Ph.D., Mayo Clinic:

Primary Outcome 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.


Enrollment: 80
Study Start Date: November 2013
Study Completion Date: September 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alert for AF Program
1) participation 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.
Active Comparator: Attention control condition
2) participation in the healthy sleep program
Behavioral: Healthy Sleep
Participants will receive a 45 minute face to face instruction about sleep hygiene

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988974


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Pamela J McCabe, PhD, RN Mayo Clinic
  More Information

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
First Submitted: November 14, 2013
First Posted: November 20, 2013
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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