Paroxysmal Atrial FibrillationMEND-AF2NCT03834844
Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)
A study testing Meditation, AF Education and Phone Calls in people with Paroxysmal Atrial Fibrillation, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Meditation, AF Education and Phone Calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?
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
- Being tested
- Meditation, AF Education, Phone Calls
- Keywords
- Symptom Management, Quality of Life, Anxiety
- Medical subject headings
- Atrial Fibrillation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
AF EducationOther
6 weekly education modules on topics related to AF
Phone CallsOther
Weekly phone call to discuss patient concerns or questions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Meditation; Other: AF Education; Other: Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Initial), 12 month
Secondary outcomes (3)
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.
Measured: Baseline (Initial), Post-Intervention (6 weeks)
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.
Measured: Baseline (Initial), 6 months
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.
Measured: Baseline (Initial), 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 May 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 factorial design
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Wang, Stanford University
- Investigators
- Linda Ottoboni, PhD, Principal investigator, Clinician and research scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834844
- Sponsor's protocol ID
- IRB-44919
- Acronym
- MEND-AF2
- Status last verified
- Nov 2024
- First submitted
- 6 Feb 2019
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?
- ClinicalTrials.gov ID
- NCT03834844
- Acronym / sponsor ID
- MEND-AF2 / IRB-44919
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Symptom Management, Quality of Life, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- 2 x 2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –patient receives same care as patients not enrolled in study intervention |
| AF education | Experimental | Other: AF EducationParticipant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. |
| Mindfulness Meditation Practice | Experimental | Behavioral: MeditationEach 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. |
| Weekly Phone Calls | Experimental | Other: Phone CallsEach 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. |
| AF Education and Mindfulness Meditation | Experimental | Behavioral: Meditation, Other: AF EducationParticipant 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. |
| AF Education and Weekly Phone Calls | Experimental | Other: AF Education, Other: Phone CallsParticipant 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. |
| Mindfulness Meditation and Phone Calls | Experimental | Behavioral: Meditation, Other: Phone CallsEach 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. |
| Meditation and Education and Phone Calls | Experimental | Behavioral: Meditation, Other: AF Education, Other: Phone CallsEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationGuided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks | Behavioural | AF Education and Mindfulness Meditation, Meditation and Education and Phone Calls, Mindfulness Meditation Practice, Mindfulness Meditation and Phone Calls |
| AF Education6 weekly education modules on topics related to AF | Other | AF Education and Mindfulness Meditation, AF Education and Weekly Phone Calls, AF education, Meditation and Education and Phone Calls |
| Phone CallsWeekly phone call to discuss patient concerns or questions | Other | AF Education and Weekly Phone Calls, Meditation and Education and Phone Calls, Mindfulness Meditation and Phone Calls, Weekly Phone Calls |
Primary outcome
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
Time frame: 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).
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
Time frame: 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).
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
Time frame: 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).
Change from Baseline in AF Quality of Life Score
Time frame: 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.
Change from Baseline in AF Quality of Life Score
Time frame: 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.
Change from Baseline in AF Quality of Life Score
Time frame: 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.
3 secondary outcomes
Change from Baseline in Anxiety
Time frame: Baseline (Initial), Post-Intervention (6 weeks)
Change from Baseline in Anxiety
Time frame: Baseline (Initial), 6 months
Change from Baseline in Anxiety
Time frame: Baseline (Initial), 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Ottoboni, PhD principal investigator
Clinician and research scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation, AF Education and Phone Calls in people with Paroxysmal Atrial Fibrillation, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores (time frame: Baseline (Initial), Post-Intervention (6 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.