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Active, Not Recruiting

NCT Number: NCT03834844

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Paroxysmal Atrial Fibrillation Anxiety Disorders Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Health Care

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditation

Behavioral

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

AF Education

Other

6 weekly education modules on topics related to AF

Phone Calls

Other

Weekly phone call to discuss patient concerns or questions

Primary outcomes

  1. Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores

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

    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).

  2. Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores

    Time frame: Baseline (Initial), 6 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).

  3. 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).

  4. Change from Baseline in AF Quality of Life Score

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

    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.

  5. Change from Baseline in AF Quality of Life Score

    Time frame: Baseline (Initial), 6 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.

  6. 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

  1. Change from Baseline in Anxiety

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

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

  2. Change from Baseline in Anxiety

    Time frame: Baseline (Initial), 6 months

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

  3. Change from Baseline in Anxiety

    Time frame: Baseline (Initial), 12 months

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: MEND-AF2

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Feb 8, 2019
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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