Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation (AF)

Y

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

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

Trial contacts and locations

0

Loading...

Central trial contact

Paul Ritvo, Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems