Feasibility Testing of the Alert for Atrial Fibrillation Program

NCT01988974 | Completed DMC

• 1 other identifier: 13-007768
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Alert for AF Program

EXPERIMENTAL

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

Behavioral: Alert for Atrial Fibrillation Program

Attention control condition

ACTIVE COMPARATOR

2\) participation in the healthy sleep program

Behavioral: Healthy Sleep

Interventions

Alert for Atrial Fibrillation Program 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.

Alert for AF Program

Healthy Sleep BEHAVIORAL

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

Attention control condition

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pamela J McCabe, PhD, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)