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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Behavioral | Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Initial), Post-Intervention (6 weeks) |
| Change from Baseline in Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
All
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| Name | Affiliation | Role |
|---|---|---|
| Linda Ottoboni, PhD | Clinician and research scientist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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2 x 2 factorial design
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|
| 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. |
|
| 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. |
|
| 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. |
|
| AF Education | Other | 6 weekly education modules on topics related to AF |
|
| Phone Calls | Other | Weekly phone call to discuss patient concerns or questions |
|
| 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. | 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. | Baseline (Initial), 12 month |
Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety. |
| 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. | Baseline (Initial), 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |