NCT03910192

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

April 8, 2019

Last Update Submit

April 8, 2019

Conditions

Atrial FibrillationHypertensionMindfulnessCardiovascular Risk Reduction

Outcome Measures

Primary Outcomes (2)

  • Night time (Sleep) Systolic Blood Pressure

    The primary outcome of this study will be change in ANBP from baseline when compared to subsequent follow-up study time points.

    16 weeks

  • Daytime time (Awake) Systolic Blood Pressure

    The primary outcome of this study will be change in daytime ABP from baseline when compared to subsequent follow-up study time points.

    16 Weeks

Secondary Outcomes (8)

  • Nocturnal Dipping

    16 Weeks

  • Atrial Tachyarrhythmia Episodes

    16 Weeks

  • Hospital Anxiety and Depression Scale (HADS)

    16 Weeks

  • Profile of Mood States (POMS-SF)

    16 Weeks

  • Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)

    16 Weeks

  • +3 more secondary outcomes

Study Arms (2)

Mindfulness meditation coaching

EXPERIMENTAL

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.

Behavioral: Mindfulness-based coaching

dietary cardiovascular risk reduction coaching

ACTIVE COMPARATOR

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.

Behavioral: Dietary cardiovascular risk reduction coaching

Interventions

Mindfulness-based coachingBEHAVIORAL

16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.

Mindfulness meditation coaching
Dietary cardiovascular risk reduction coachingBEHAVIORAL

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.

dietary cardiovascular risk reduction coaching

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Scheduled for Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationHypertension

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Officials

  • Paul Ritvo, Ph.D

    York Univrsity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Ritvo, Ph.D

CONTACT

416-736-2100pritvo@yorku.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 10, 2019

Study Start

March 14, 2017

Primary Completion

August 31, 2019

Study Completion

December 31, 2019

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)