ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03834844
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Wang, Stanford University

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
AF Symptom Severity, Anxiety, Quality of Life Behavioral: Meditation Other: AF Education Other: Phone Calls Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2 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: Do They Need to Be Offered Together?
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from Baseline Atrial Fibrillation Symptom Frequency and Severity Score [ Time Frame: Baseline (Initial), Post-Intervention (6 weeks) ]
    Atrial Fibrillation Symptom Frequency and Severity will be assessed using the Atrial Fibrillation Symptom Frequency and Severity Scale

  2. Change from Baseline Atrial Fibrillation Symptom Frequency and Severity Score [ Time Frame: Baseline (Initial), 6 month ]
    Atrial Fibrillation Symptom Frequency and Severity will be assessed using the Atrial Fibrillation Symptom Frequency and Severity Scale

  3. Change from Baseline Atrial Fibrillation Symptom Frequency and Severity Score [ Time Frame: Baseline (Initial), 12 month ]
    Atrial Fibrillation Symptom Frequency and Severity will be assessed using the Atrial Fibrillation Symptom Frequency and Severity Scale

  4. Change from Baseline in Quality of Life Score [ Time Frame: Baseline (Initial), Post-Intervention (6 weeks) ]
    Quality of Life will be assessed using the Atrial Fibrillation Effect on Quality of Life Questionnaire

  5. Change from Baseline in Quality of Life Score [ Time Frame: Baseline (Initial), 6 month ]
    Quality of Life will be assessed using the Atrial Fibrillation Effect on Quality of Life Questionnaire

  6. Change from Baseline in Quality of Life Score [ Time Frame: Baseline (Initial), 12 month ]
    Quality of Life will be assessed using the Atrial Fibrillation Effect on Quality of Life Questionnaire


Secondary Outcome Measures :
  1. Change from Baseline in Anxiety [ Time Frame: Baseline (Initial), Post-Intervention (6 weeks) ]
    Anxiety will be measured using the Cardiac Anxiety Questionnaire

  2. Change from Baseline in Anxiety [ Time Frame: Baseline (Initial), 6 months ]
    Anxiety will be measured using the Cardiac Anxiety Questionnaire

  3. Change from Baseline in Anxiety [ Time Frame: Baseline (Initial), 12 months ]
    Anxiety will be measured using the Cardiac Anxiety Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All
Accepts Healthy Volunteers:   No
Criteria

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 sessions in clinic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834844


Contacts
Contact: Linda Ottoboni, PhD 6504985914 lottoboni@stanfordhealthcare.org

Locations
United States, California
Stanford Health Care Recruiting
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Linda Ottoboni, PhD Clinician and research scientist

Responsible Party: Paul Wang, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03834844     History of Changes
Other Study ID Numbers: IRB-44919
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
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, Stanford University:
Symptom management, Illness perception, functional status