Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Paroxysmal Atrial Fibrillation
- Sponsor
- Stanford University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The aim of this project is to determine whether the entire intervention (Mindfulness meditation, AF education, and weekly phone visits) that is nurse delivered to individuals with paroxysmal atrial fibrillation is more effective than a combination, single or no intervention in the reduction of overall AF symptoms, anxiety, and negative illness perception; or the improvement of quality of life (QOL) and functional status.
Investigators
Paul Wang
Professor of Medicine
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Individuals with Symptomatic Paroxysmal Atrial Fibrillation
- •A symptomatic episode of PAF within last 6 months
- •18 years old or greater
- •Able to read and understand English
- •Able to participate in weekly phone calls
- •Able to attend two video visit/phone sessions that are 6 weeks apart
Exclusion Criteria
- •Diagnosed with low cardiac function (NYHA Class IV)
- •Life expectancy of less than 6 months
- •Hospitalized in prior 3 months for illness other than PAF
- •Previously practiced mindfulness
- •Cognitive impairment
Outcomes
Primary Outcomes
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
Time Frame: Baseline (Initial), 12 month
Atrial Fibrillation Burden and Symptom Severity will be calculated from the patient-completed responses on the Atrial Fibrillation Symptom Severity Scale-Symptom Burden can range from 3.25 (minimally bothersome) to 30 (continuous symptomatic episodes) and is based on event frequency (1-10), duration (1.25-10), and global episode (1-10). Symptom severity is based on symptom specific subscale with range from 0(no symptoms) to 35 (severe symptoms).
Change from Baseline in AF Quality of Life Score
Time Frame: Baseline (Initial), 12 month
Quality of Life will be assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire. The AFEQT score is a combined score of 21 items (21-100) with a higher score representing greater QOL.
Secondary Outcomes
- Change from Baseline in Anxiety(Baseline (Initial), 12 months)