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Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation (AF)

Primary Purpose

Atrial Fibrillation, Hypertension, Mindfulness

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-based coaching
Dietary cardiovascular risk reduction coaching
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Southlake Regional Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness meditation coaching

dietary cardiovascular risk reduction coaching

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Nocturnal Dipping
ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values
Atrial Tachyarrhythmia Episodes
24-hour Holter monitoring assessments using the MARS® ambulatory ECG system at baseline and 4 months to assess atrial tachyarrhythmia episodes lasting 30 seconds or more
Hospital Anxiety and Depression Scale (HADS)
14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations
Profile of Mood States (POMS-SF)
65 item self-report questionnaire examining mood and changes in mood over a period, POMS, in both original and shorter 37 item format, has been extensively used in clinical settings
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
24 item the magnitude and changes over time in mindfulness levels, including its five - observing, describing experience, acting with awareness, non-judging of inner experience, and nonreactivity to inner experience facets.
SF-12 v2 Health Survey
assesses self reported physical and mental health, providing separate scores for 8 sub-domains of physical and mental health (e.g. physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).
Pittsburgh Sleep Quality Index (PSQI)
The instrument, widely used in epidemiological or clinical contexts, is comprised of seven sub-components (i.e. sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, medication use, and daytime dysfunction) leading to a global sleep quality score.
Cardiac Anxiety Questionnaire (CAQ)
18 item index of HFA, a measure of anxiety sensitivity specific to cardiovascular patients. The CAQ conceptualizes HFA as a 3 dimensional measure, including heart-related fear, avoidance, attention subscales.

Full Information

First Posted
April 8, 2019
Last Updated
April 8, 2019
Sponsor
York University
Collaborators
Southlake Regional Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03910192
Brief Title
Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation
Acronym
AF
Official Title
Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
Southlake Regional Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Hypertension, Mindfulness, Cardiovascular Risk Reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness meditation coaching
Arm Type
Experimental
Arm 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.
Arm Title
dietary cardiovascular risk reduction coaching
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based coaching
Intervention Description
16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
Intervention Type
Behavioral
Intervention Name(s)
Dietary cardiovascular risk reduction coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Night time (Sleep) Systolic Blood Pressure
Description
The primary outcome of this study will be change in ANBP from baseline when compared to subsequent follow-up study time points.
Time Frame
16 weeks
Title
Daytime time (Awake) Systolic Blood Pressure
Description
The primary outcome of this study will be change in daytime ABP from baseline when compared to subsequent follow-up study time points.
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Nocturnal Dipping
Description
ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values
Time Frame
16 Weeks
Title
Atrial Tachyarrhythmia Episodes
Description
24-hour Holter monitoring assessments using the MARS® ambulatory ECG system at baseline and 4 months to assess atrial tachyarrhythmia episodes lasting 30 seconds or more
Time Frame
16 Weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations
Time Frame
16 Weeks
Title
Profile of Mood States (POMS-SF)
Description
65 item self-report questionnaire examining mood and changes in mood over a period, POMS, in both original and shorter 37 item format, has been extensively used in clinical settings
Time Frame
16 Weeks
Title
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Description
24 item the magnitude and changes over time in mindfulness levels, including its five - observing, describing experience, acting with awareness, non-judging of inner experience, and nonreactivity to inner experience facets.
Time Frame
16 Weeks
Title
SF-12 v2 Health Survey
Description
assesses self reported physical and mental health, providing separate scores for 8 sub-domains of physical and mental health (e.g. physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).
Time Frame
16 Weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The instrument, widely used in epidemiological or clinical contexts, is comprised of seven sub-components (i.e. sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, medication use, and daytime dysfunction) leading to a global sleep quality score.
Time Frame
16 Weeks
Title
Cardiac Anxiety Questionnaire (CAQ)
Description
18 item index of HFA, a measure of anxiety sensitivity specific to cardiovascular patients. The CAQ conceptualizes HFA as a 3 dimensional measure, including heart-related fear, avoidance, attention subscales.
Time Frame
16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Ritvo, Ph.D
Phone
416-736-2100
Ext
22396
Email
pritvo@yorku.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Ritvo, Ph.D
Organizational Affiliation
York Univrsity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Ritvo, PhD
Phone
4165808021
Email
pritvo@yorku.ca
First Name & Middle Initial & Last Name & Degree
Paul Ritvo, PhD
First Name & Middle Initial & Last Name & Degree
Meysam Pirbaglou, MSc
First Name & Middle Initial & Last Name & Degree
Yaariv Khaykin, MD
First Name & Middle Initial & Last Name & Degree
Pouria Alipour, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation

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