Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Night time (Sleep) Systolic Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Scheduled for Surgery
研究组 & 干预措施
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.
干预措施: Mindfulness-based coaching (Behavioral)
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.
干预措施: Dietary cardiovascular risk reduction coaching (Behavioral)
结局指标
主要结局
Night time (Sleep) Systolic Blood Pressure
时间窗: 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
时间窗: 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.
次要结局
- Atrial Tachyarrhythmia Episodes(16 Weeks)
- Hospital Anxiety and Depression Scale (HADS)(16 Weeks)
- SF-12 v2 Health Survey(16 Weeks)
- Profile of Mood States (POMS-SF)(16 Weeks)
- Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)(16 Weeks)
- Nocturnal Dipping(16 Weeks)
- Pittsburgh Sleep Quality Index (PSQI)(16 Weeks)
- Cardiac Anxiety Questionnaire (CAQ)(16 Weeks)