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

Study Overview
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Brief Summary
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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.

Official Title
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Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Behavioral: Meditation
* Other: AF Education
* Other: Phone Calls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2 x 2 factorial design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>patient receives same care as patients not enrolled in study intervention | |
| Experimental: AF education<br>Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. | Other: AF Education<br>* 6 weekly education modules on topics related to AF<br>|
| Experimental: Mindfulness Meditation Practice<br>Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6. | Behavioral: Meditation<br>* Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks<br>|
| Experimental: Weekly Phone Calls<br>Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes. | Other: Phone Calls<br>* Weekly phone call to discuss patient concerns or questions<br>|
| Experimental: AF Education and Mindfulness Meditation<br>Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6. | Behavioral: Meditation<br>* Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks<br>Other: AF Education<br>* 6 weekly education modules on topics related to AF<br>|
| Experimental: AF Education and Weekly Phone Calls<br>Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes. | Other: AF Education<br>* 6 weekly education modules on topics related to AF<br>Other: Phone Calls<br>* Weekly phone call to discuss patient concerns or questions<br>|
| Experimental: Mindfulness Meditation and Phone Calls<br>Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes. | Behavioral: Meditation<br>* Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks<br>Other: Phone Calls<br>* Weekly phone call to discuss patient concerns or questions<br>|
| Experimental: Meditation and Education and Phone Calls<br>Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes. | Behavioral: Meditation<br>* Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks<br>Other: AF Education<br>* 6 weekly education modules on topics related to AF<br>Other: Phone Calls<br>* Weekly phone call to discuss patient concerns or questions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline (Initial), Post-Intervention (6 weeks) | 
| 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). | Baseline (Initial), 6 month | 
| 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). | 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. | Baseline (Initial), Post-Intervention (6 weeks) | 
| 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. | Baseline (Initial), 6 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. | Baseline (Initial), 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline (Initial), 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom Management, Quality of Life, Anxiety