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

Paroxysmal Atrial Fibrillation Clinical Trial

— MEND-AF2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03834844
• Other study ID #: IRB-44919
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Stanford University
• Contact: Linda Ottoboni, PhD
• Phone: 6504985914
• Email: lottoboni[@]stanfordhealthcare.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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

Other:
• AF Education
6 weekly education modules on topics related to AF
• Phone Calls
Weekly phone call to discuss patient concerns or questions

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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	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)
Secondary	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
Secondary	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