Feasibility Testing of the Alert for Atrial Fibrillation Program

Atrial Fibrillation Clinical Trial

Official title:

Feasibility Testing of the Alert for Atrial Fibrillation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988974
• Other study ID #: 13-007768
• Status: Completed
• Phase: N/A
• First received: November 14, 2013
• Last updated: March 22, 2017
• Start date: November 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey	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.	Baseline, One Month, Two Months