<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03834844</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-44919</org_study_id>
    <nct_id>NCT03834844</nct_id>
  </id_info>
  <brief_title>Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)</brief_title>
  <acronym>MEND-AF2</acronym>
  <official_title>Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project is to determine whether the entire intervention (Mindfulness&#xD;
      meditation, AF education, and weekly phone visits) that is nurse delivered to individuals&#xD;
      with paroxysmal atrial fibrillation is more effective than a combination, single or no&#xD;
      intervention in the reduction of overall AF symptoms, anxiety, and negative illness&#xD;
      perception; or the improvement of quality of life (QOL) and functional status.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>2 x 2 factorial design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores</measure>
    <time_frame>Baseline (Initial), Post-Intervention (6 weeks)</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores</measure>
    <time_frame>Baseline (Initial), 6 month</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores</measure>
    <time_frame>Baseline (Initial), 12 month</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in AF Quality of Life Score</measure>
    <time_frame>Baseline (Initial), Post-Intervention (6 weeks)</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in AF Quality of Life Score</measure>
    <time_frame>Baseline (Initial), 6 month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in AF Quality of Life Score</measure>
    <time_frame>Baseline (Initial), 12 month</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Anxiety</measure>
    <time_frame>Baseline (Initial), Post-Intervention (6 weeks)</time_frame>
    <description>Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Anxiety</measure>
    <time_frame>Baseline (Initial), 6 months</time_frame>
    <description>Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Anxiety</measure>
    <time_frame>Baseline (Initial), 12 months</time_frame>
    <description>Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patient receives same care as patients not enrolled in study intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AF education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness Meditation Practice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weekly Phone Calls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AF Education and Mindfulness Meditation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AF Education and Weekly Phone Calls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness Meditation and Phone Calls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meditation and Education and Phone Calls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Meditation</intervention_name>
    <description>Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks</description>
    <arm_group_label>AF Education and Mindfulness Meditation</arm_group_label>
    <arm_group_label>Meditation and Education and Phone Calls</arm_group_label>
    <arm_group_label>Mindfulness Meditation Practice</arm_group_label>
    <arm_group_label>Mindfulness Meditation and Phone Calls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AF Education</intervention_name>
    <description>6 weekly education modules on topics related to AF</description>
    <arm_group_label>AF Education and Mindfulness Meditation</arm_group_label>
    <arm_group_label>AF Education and Weekly Phone Calls</arm_group_label>
    <arm_group_label>AF education</arm_group_label>
    <arm_group_label>Meditation and Education and Phone Calls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phone Calls</intervention_name>
    <description>Weekly phone call to discuss patient concerns or questions</description>
    <arm_group_label>AF Education and Weekly Phone Calls</arm_group_label>
    <arm_group_label>Meditation and Education and Phone Calls</arm_group_label>
    <arm_group_label>Mindfulness Meditation and Phone Calls</arm_group_label>
    <arm_group_label>Weekly Phone Calls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Individuals with Symptomatic Paroxysmal Atrial Fibrillation&#xD;
&#xD;
          2. A symptomatic episode of PAF within last 6 months&#xD;
&#xD;
          3. 18 years old or greater&#xD;
&#xD;
          4. Able to read and understand English&#xD;
&#xD;
          5. Able to participate in weekly phone calls&#xD;
&#xD;
          6. Able to attend two video visit/phone sessions that are 6 weeks apart&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with low cardiac function (NYHA Class IV)&#xD;
&#xD;
          2. Life expectancy of less than 6 months&#xD;
&#xD;
          3. Hospitalized in prior 3 months for illness other than PAF&#xD;
&#xD;
          4. Previously practiced mindfulness&#xD;
&#xD;
          5. Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda Ottoboni, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinician and research scientist</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Linda Ottoboni, PhD</last_name>
    <phone>6504985914</phone>
    <email>lottoboni@stanfordhealthcare.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford Health Care</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>December 6, 2022</last_update_submitted>
  <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Paul Wang</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Symptom Management</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03834844
org study id: IRB-44919
nct id: NCT03834844
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: 2 x 2 factorial design
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
time frame: Baseline (Initial), Post-Intervention (6 weeks)
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).
measure: Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
time frame: Baseline (Initial), 6 month
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).
measure: Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
time frame: Baseline (Initial), 12 month
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).
measure: Change from Baseline in AF Quality of Life Score
time frame: Baseline (Initial), Post-Intervention (6 weeks)
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.
measure: Change from Baseline in AF Quality of Life Score
time frame: Baseline (Initial), 6 month
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.
measure: Change from Baseline in AF Quality of Life Score
time frame: Baseline (Initial), 12 month
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.
measure: Change from Baseline in Anxiety
time frame: Baseline (Initial), Post-Intervention (6 weeks)
description: Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.
measure: Change from Baseline in Anxiety
time frame: Baseline (Initial), 6 months
description: Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.
measure: Change from Baseline in Anxiety
time frame: Baseline (Initial), 12 months
description: Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.
arm group label: Usual Care
arm group type: No Intervention
description: patient receives same care as patients not enrolled in study intervention
arm group label: AF education
arm group type: Experimental
description: Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.
arm group label: Mindfulness Meditation Practice
arm group type: Experimental
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 group label: Weekly Phone Calls
arm group type: Experimental
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 group label: AF Education and Mindfulness Meditation
arm group type: Experimental
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 group label: AF Education and Weekly Phone Calls
arm group type: Experimental
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 group label: Mindfulness Meditation and Phone Calls
arm group type: Experimental
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 group label: Meditation and Education and Phone Calls
arm group type: Experimental
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: Meditation
description: Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
arm group label: AF Education and Mindfulness Meditation
arm group label: Meditation and Education and Phone Calls
arm group label: Mindfulness Meditation Practice
arm group label: Mindfulness Meditation and Phone Calls
intervention type: Other
intervention name: AF Education
description: 6 weekly education modules on topics related to AF
arm group label: AF Education and Mindfulness Meditation
arm group label: AF Education and Weekly Phone Calls
arm group label: AF education
arm group label: Meditation and Education and Phone Calls
intervention type: Other
intervention name: Phone Calls
description: Weekly phone call to discuss patient concerns or questions
arm group label: AF Education and Weekly Phone Calls
arm group label: Meditation and Education and Phone Calls
arm group label: Mindfulness Meditation and Phone Calls
arm group label: Weekly Phone Calls
criteria: 
gender: All
gender based: Yes
gender description: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Linda Ottoboni, PhD
role: Principal Investigator
affiliation: Clinician and research scientist
last name: Linda Ottoboni, PhD
phone: 6504985914
email: lottoboni@stanfordhealthcare.org
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Paul Wang
investigator title: Professor of Medicine
mesh term: Atrial Fibrillation
sharing ipd: No