Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)

N/AActive Not RecruitingNCT03834844

Stanford University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

MeditationBEHAVIORAL

Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks

AF EducationOTHER

6 weekly education modules on topics related to AF

Phone CallsOTHER

Weekly phone call to discuss patient concerns or questions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Individuals with Symptomatic Paroxysmal Atrial Fibrillation 2. A symptomatic episode of PAF within last 6 months 3. 18 years old or greater 4. Able to read and understand English 5. Able to participate in weekly phone calls 6. Able to attend two video visit/phone sessions that are 6 weeks apart Exclusion Criteria: 1. Diagnosed with low cardiac function (NYHA Class IV) 2. Life expectancy of less than 6 months 3. Hospitalized in prior 3 months for illness other than PAF 4. Previously practiced mindfulness 5. Cognitive impairment

Locations (1)

Stanford Health Care

Stanford, California, United States

Outcomes

Primary Outcomes

Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores

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).

Time frame: Baseline (Initial), Post-Intervention (6 weeks)

Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores

Time frame: Baseline (Initial), 6 month

Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores

Time frame: Baseline (Initial), 12 month

Change from Baseline in AF Quality of Life Score

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.

Time frame: Baseline (Initial), Post-Intervention (6 weeks)

Data from ClinicalTrials.gov

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Secondary Outcomes

Change from Baseline in Anxiety

Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.

Time frame: Baseline (Initial), Post-Intervention (6 weeks)

Change from Baseline in Anxiety

Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.

Time frame: Baseline (Initial), 6 months

Change from Baseline in Anxiety

Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.

Time frame: Baseline (Initial), 12 months