Hypertension Clinical Trial
— AFOfficial title:
Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation
Verified date | April 2019 |
Source | York University |
Contact | Paul Ritvo, Ph.D |
Phone | 416-736-2100 |
pritvo[@]yorku.ca | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Southlake Regional Health Centre | Newmarket | Ontario |
Lead Sponsor | Collaborator |
---|---|
York University | Southlake Regional Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Nocturnal Dipping | ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values | 16 Weeks | |
Secondary | Atrial Tachyarrhythmia Episodes | 24-hour Holter monitoring assessments using the MARSĀ® ambulatory ECG system at baseline and 4 months to assess atrial tachyarrhythmia episodes lasting 30 seconds or more | 16 Weeks | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | 14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations | 16 Weeks | |
Secondary | 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 | 16 Weeks | |
Secondary | 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. | 16 Weeks | |
Secondary | 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). | 16 Weeks | |
Secondary | 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. | 16 Weeks | |
Secondary | 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. | 16 Weeks |
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