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Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF) (MEND-AF2)

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation
AF Education
Phone Calls
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Symptom Management, Quality of Life, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Usual Care

AF education

Mindfulness Meditation Practice

Weekly Phone Calls

AF Education and Mindfulness Meditation

AF Education and Weekly Phone Calls

Mindfulness Meditation and Phone Calls

Meditation and Education and Phone Calls

Arm Description

patient receives same care as patients not enrolled in study intervention

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 6, 2019
Last Updated
December 6, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03834844
Brief Title
Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)
Acronym
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?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Symptom Management, Quality of Life, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 x 2 factorial design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
patient receives same care as patients not enrolled in study intervention
Arm Title
AF education
Arm Type
Experimental
Arm Description
Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.
Arm Title
Mindfulness Meditation Practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Weekly Phone Calls
Arm Type
Experimental
Arm Description
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.
Arm Title
AF Education and Mindfulness Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
AF Education and Weekly Phone Calls
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness Meditation and Phone Calls
Arm Type
Experimental
Arm Description
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.
Arm Title
Meditation and Education and Phone Calls
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Intervention Description
Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
Intervention Type
Other
Intervention Name(s)
AF Education
Intervention Description
6 weekly education modules on topics related to AF
Intervention Type
Other
Intervention Name(s)
Phone Calls
Intervention Description
Weekly phone call to discuss patient concerns or questions
Primary Outcome Measure Information:
Title
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
Description
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)
Title
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
Description
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), 6 month
Title
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
Description
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), 12 month
Title
Change from Baseline in AF Quality of Life Score
Description
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)
Title
Change from Baseline in AF Quality of Life Score
Description
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), 6 month
Title
Change from Baseline in AF Quality of Life Score
Description
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), 12 month
Secondary Outcome Measure Information:
Title
Change from Baseline in Anxiety
Description
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)
Title
Change from Baseline in Anxiety
Description
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
Title
Change from Baseline in Anxiety
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Ottoboni, PhD
Phone
6504985914
Email
lottoboni@stanfordhealthcare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Ottoboni, PhD
Organizational Affiliation
Clinician and research scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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