Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation
NCT ID: NCT03910192
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2017-03-14
2019-12-31
Brief Summary
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Both groups will undergo 24-hour ambulatory blood pressure monitoring, along with assessments of psychological measures (see bellow) at study baseline, midpoint (8 weeks), and conclusion (16 weeks).
In addition, both groups will also undergo 24-hour Holter monitoring assessments at study beginning and conclusion to assess possible episodes of atrial tachyarrhythmia during the assessed interval.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mindfulness meditation coaching
Mindfulness-based coaching - participants will receive instructions on (a) mindfulness meditation and gentle mindful movement through home-based and in-class participation at the Southlake Cardiovascular Rehabilitation Clinic and (b) personal coaching support. The health coach will further assist participants through either face-to-face or telephone-based discussions. They will meet with the health coach at mutually-agreed upon on times for designated time periods.
Mindfulness-based coaching
16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
dietary cardiovascular risk reduction coaching
Cardiovascular risk reduction education - No change to standard of care where participants will receive instructions (in person or by phone call) on how to integrate exercise and dietary changes in your lifestyle to reduce your risk of future cardiovascular events. These instructions will be centered around the DASH dietary practices.
Dietary cardiovascular risk reduction coaching
Regular in-person meetings, phone calls, or email from study coordinator instructing them on how to integrate exercise and dietary changes in their lifestyle to reduce their risk of future cardiovascular events.
Interventions
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Mindfulness-based coaching
16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
Dietary cardiovascular risk reduction coaching
Regular in-person meetings, phone calls, or email from study coordinator instructing them on how to integrate exercise and dietary changes in their lifestyle to reduce their risk of future cardiovascular events.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed Atrial Fibrillation
* Night time (Sleep Time) Systolic Blood Pressure≥120 OR Daytime (awake) Systolic Blood Pressure ≥ 135
* Able and Willing to sign Informed Consent Form
Exclusion Criteria
50 Years
80 Years
ALL
No
Sponsors
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Southlake Regional Health Centre
OTHER
York University
OTHER
Responsible Party
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Paul Ritvo
Full Professor
Principal Investigators
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Paul Ritvo, Ph.D
Role: PRINCIPAL_INVESTIGATOR
York Univrsity
Locations
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Southlake Regional Health Centre
Newmarket, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0031-1617
Identifier Type: -
Identifier Source: org_study_id
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