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

NCT03834844 | Active Not Recruiting

• 1 other identifier: IRB-44919
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Symptom Management; Quality of Life; Anxiety

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Change from Baseline in Anxiety

  Baseline (Initial), Post-Intervention (6 weeks)

• Change from Baseline in Anxiety

  Baseline (Initial), 6 months

• Change from Baseline in Anxiety

  Baseline (Initial), 12 months

Study Arms (8)

Usual Care

NO INTERVENTION

patient receives same care as patients not enrolled in study intervention

AF education

EXPERIMENTAL

Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.

Other: AF Education

Mindfulness Meditation Practice

EXPERIMENTAL

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

Weekly Phone Calls

EXPERIMENTAL

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

AF Education and Mindfulness Meditation

EXPERIMENTAL

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; Other: AF Education

AF Education and Weekly Phone Calls

EXPERIMENTAL

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; Other: Phone Calls

Mindfulness Meditation and Phone Calls

EXPERIMENTAL

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; Other: Phone Calls

Meditation and Education and Phone Calls

EXPERIMENTAL

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; Other: AF Education; Other: Phone Calls

Interventions

Meditation BEHAVIORAL

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

AF Education and Mindfulness Meditation; Meditation and Education and Phone Calls; Mindfulness Meditation Practice; Mindfulness Meditation and Phone Calls

AF Education OTHER

6 weekly education modules on topics related to AF

AF Education and Mindfulness Meditation; AF Education and Weekly Phone Calls; AF education; Meditation and Education and Phone Calls

Phone Calls OTHER

Weekly phone call to discuss patient concerns or questions

AF Education and Weekly Phone Calls; Meditation and Education and Phone Calls; Mindfulness Meditation and Phone Calls; Weekly Phone Calls

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with Symptomatic Paroxysmal Atrial Fibrillation
• A symptomatic episode of PAF within last 6 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Anxiety Disorders

Interventions

Meditation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Linda Ottoboni, PhD

  Clinician and research scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 2 x 2 factorial design

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: May 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)