Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation (AF)

York University

Status: Unknown

Conditions: Hypertension; Atrial Fibrillation; Cardiovascular Risk Reduction; Mindfulness

Treatments: Behavioral: Mindfulness-based coaching; Behavioral: Dietary cardiovascular risk reduction coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT03910192

0031-1617

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Mindfulness meditation coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based coaching

dietary cardiovascular risk reduction coaching

Active Comparator group

Description:

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.

Treatment:

Behavioral: Dietary cardiovascular risk reduction coaching