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

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03834844
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 8
• Anticipated Duration (Months): 56
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Paroxysmal Atrial Fibrillation	Behavioral: Meditation; Other: AF Education; Other: Phone Calls	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: 2 x 2 factorial design2 x 2 factorial design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?
• Actual Study Start Date: May 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care patient receives same care as patients not enrolled in study intervention
Experimental: AF education Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.	Other: AF Education; 6 weekly education modules on topics related to AF
Experimental: Mindfulness Meditation Practice 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; Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
Experimental: Weekly Phone Calls 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; Weekly phone call to discuss patient concerns or questions
Experimental: AF Education and Mindfulness Meditation 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; 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
Experimental: AF Education and Weekly Phone Calls 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; 6 weekly education modules on topics related to AF; Other: Phone Calls; Weekly phone call to discuss patient concerns or questions
Experimental: Mindfulness Meditation and Phone Calls 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; Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks; Other: Phone Calls; Weekly phone call to discuss patient concerns or questions
Experimental: Meditation and Education and Phone Calls 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; 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; Other: Phone Calls; Weekly phone call to discuss patient concerns or questions

Outcome Measures

Primary Outcome Measures

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

1. Change from Baseline in Anxiety [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Health Care	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Linda Ottoboni, PhD, Clinician and research scientist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul Wang, Professor of Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT03834844
• Other Study ID Numbers: IRB-44919
• First Posted: Feb 8, 2019
• Last Update Posted: Apr 12, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Paul Wang, Professor of Medicine, Stanford University: Symptom Management; Quality of Life; Anxiety
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Apr 12, 2021