Feasibility Testing of the Alert for Atrial Fibrillation Program
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alert for Atrial Fibrillation Program
Healthy Sleep
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alert for AF Program
Attention control condition
Arm Description
1) participation in the Alert for Atrial Fibrillation program ) .
2) participation in the healthy sleep program
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01988974
Brief Title
Feasibility Testing of the Alert for Atrial Fibrillation Program
Official Title
Feasibility Testing of the Alert for Atrial Fibrillation Program
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alert for AF Program
Arm Type
Experimental
Arm Description
1) participation in the Alert for Atrial Fibrillation program ) .
Arm Title
Attention control condition
Arm Type
Active Comparator
Arm Description
2) participation in the healthy sleep program
Intervention Type
Behavioral
Intervention Name(s)
Alert for Atrial Fibrillation Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Sleep
Intervention Description
Participants will receive a 45 minute face to face instruction about sleep hygiene
Primary Outcome Measure Information:
Title
Changes on the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey
Description
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.
Time Frame
Baseline, One Month, Two Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela J McCabe, PhD, RN
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Testing of the Alert for Atrial Fibrillation Program
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