Atrial FibrillationAFNCT03910192
Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation
A study testing Mindfulness-based coaching and Dietary cardiovascular risk reduction coaching in people with Atrial Fibrillation and Hypertension, run by York University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Hypertension, Mindfulness
- What is being tested?
- Mindfulness-based coaching and Dietary cardiovascular risk reduction coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Scheduled for Surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Paul Ritvo, PhD, 4165808021, pritvo@yorku.ca
Paul Ritvo, PhD
About this study
Official title: Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation
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.
- Being tested
- Mindfulness-based coaching, Dietary cardiovascular risk reduction coaching
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based coachingBehavioural
16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
Dietary cardiovascular risk reduction coachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Dietary cardiovascular risk reduction coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 Weeks
Secondary outcomes (8)
Nocturnal Dipping
ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values
Measured: 16 Weeks
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
Measured: 16 Weeks
Hospital Anxiety and Depression Scale (HADS)
14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations
Measured: 16 Weeks
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
Measured: 16 Weeks
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.
Measured: 16 Weeks
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).
Measured: 16 Weeks
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.
Measured: 16 Weeks
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.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start14 Mar 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Southlake Health
- Responsible party
- Principal investigator, Paul Ritvo, York University
- Investigators
- Paul Ritvo, Ph.D, Principal investigator, York Univrsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910192
- Sponsor's protocol ID
- 0031-1617
- Acronym
- AF
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03910192
- Acronym / sponsor ID
- AF / 0031-1617
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Southlake Health
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation coaching | Experimental | Behavioral: Mindfulness-based coachingMindfulness-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. |
| dietary cardiovascular risk reduction coaching | Active comparator | Behavioral: Dietary cardiovascular risk reduction coachingCardiovascular 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Scheduled for Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based coaching16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement. | Behavioural | Mindfulness meditation coaching |
| Dietary cardiovascular risk reduction coachingRegular 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. | Behavioural | dietary cardiovascular risk reduction coaching |
Primary outcome
Night time (Sleep) Systolic Blood Pressure
Time frame: 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
Time frame: 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.
8 secondary outcomes
Nocturnal Dipping
Time frame: 16 Weeks
Atrial Tachyarrhythmia Episodes
Time frame: 16 Weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 16 Weeks
Profile of Mood States (POMS-SF)
Time frame: 16 Weeks
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Time frame: 16 Weeks
SF-12 v2 Health Survey
Time frame: 16 Weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 16 Weeks
Cardiac Anxiety Questionnaire (CAQ)
Time frame: 16 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Ritvo, Ph.D principal investigator
York Univrsity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based coaching and Dietary cardiovascular risk reduction coaching in people with Atrial Fibrillation and Hypertension, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Ritvo, Ph.D (416-736-2100 ext. 22396, pritvo@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Night time (Sleep) Systolic Blood Pressure (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.