Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation

NCT ID: NCT03910192

Last Updated: 2019-04-10

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-14

Study Completion Date

2019-12-31

Brief Summary

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The aim of this study is to evaluate the effectiveness of a 16 week mindfulness-based coaching program compared to a cardiovascular risk reduction education program.

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.

Detailed Description

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Conditions

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Atrial Fibrillation Hypertension Mindfulness Cardiovascular Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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.

Group Type EXPERIMENTAL

Mindfulness-based coaching

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Dietary cardiovascular risk reduction coaching

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 50-80
* 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

* Scheduled for Surgery
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southlake Regional Health Centre

OTHER

Sponsor Role collaborator

York University

OTHER

Sponsor Role lead

Responsible Party

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Paul Ritvo

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Paul Ritvo, Ph.D

Role: CONTACT

416-736-2100 ext. 22396

Facility Contacts

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Paul Ritvo, PhD

Role: primary

4165808021

Other Identifiers

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0031-1617

Identifier Type: -

Identifier Source: org_study_id

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