Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF) (MEND-AF2)
Status
Active, not recruiting
Conditions
Paroxysmal Atrial Fibrillation
Treatments
Behavioral: Meditation
Other: AF Education
Other: Phone Calls
Details and patient eligibility
About
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.
Enrollment
50 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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 design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
None (Open label)
50 participants in 8 patient groups
Usual Care
No Intervention group
Description:
patient receives same care as patients not enrolled in study intervention
AF education
Experimental group
Description:
Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.
Treatment:
Other: AF Education
Mindfulness Meditation Practice
Experimental group
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.
Treatment:
Behavioral: Meditation
Weekly Phone Calls
Experimental group
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.
Treatment:
Other: Phone Calls
AF Education and Mindfulness Meditation
Experimental group
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.
Treatment:
Other: AF Education
Behavioral: Meditation
AF Education and Weekly Phone Calls
Experimental group
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.
Treatment:
Other: Phone Calls
Other: AF Education
Mindfulness Meditation and Phone Calls
Experimental group
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.
Treatment:
Other: Phone Calls
Behavioral: Meditation
Meditation and Education and Phone Calls
Experimental group
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.
Treatment:
Other: Phone Calls
Other: AF Education
Behavioral: Meditation
Trial contacts and locations
1
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Central trial contact
Linda Ottoboni, PhD
Data sourced from clinicaltrials.gov
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