AF: Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation

Sponsor

York University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03910192

Collaborator

Southlake Regional Health Centre (Other)

Enrollment

Location

Arms

33.6

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Hypertension Mindfulness Cardiovascular Risk Reduction	Behavioral: Mindfulness-based coaching Behavioral: Dietary cardiovascular risk reduction coaching	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation

Actual Study Start Date :

Mar 14, 2017

Anticipated Primary Completion Date :

Aug 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Mindfulness-based coaching 16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Mindfulness-based coaching

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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

Night time (Sleep) Systolic Blood Pressure [16 weeks]
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 [16 Weeks]
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 [16 Weeks]
ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values
Atrial Tachyarrhythmia Episodes [16 Weeks]
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) [16 Weeks]
14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations
Profile of Mood States (POMS-SF) [16 Weeks]
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) [16 Weeks]
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 [16 Weeks]
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) [16 Weeks]
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) [16 Weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southlake Regional Health Centre	Newmarket	Ontario	Canada	L3Y 2P9

Sponsors and Collaborators

York University
Southlake Regional Health Centre

Investigators

Principal Investigator: Paul Ritvo, Ph.D, York Univrsity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul Ritvo, Full Professor, York University

ClinicalTrials.gov Identifier:

NCT03910192

Other Study ID Numbers:

0031-1617

First Posted:

Apr 10, 2019

Last Update Posted:

Apr 10, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Atrial Fibrillation

Study Results

No Results Posted as of Apr 10, 2019