Smartphone Delivered Meditation for BP Control Among Prehypertensives

智能手机为高血压前期患者提供控制血压的冥想

• 批准号: 8506076
• 负责人: Frank A Treiber
• 金额: $ 67.7万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8506076
• 关键词: Address; Adherence; Adult; Affect; African American; Anxiety; Awareness; Behavioral; Blood Pressure; Breathing; Cardiovascular Diseases; Cognitive; Consensus; Data; Development; Dietary Intervention; Education; Effectiveness; Enrollment; Equilibrium; Essential Hypertension; Ethnic group; Event; Feedback; Focus Groups; Future; Geographic Locations; Health Personnel; Health Technology; Health education; Heart Rate; Hostility; Hour; Hydrocortisone; Individual; Intervention; Interview; Learning; Life Style; Link; Locales; Maintenance; Measures; Mediator of activation protein; Meditation; Modeling; Modification; Monitor; Outcome; Patients; Pharmacotherapy; Physical activity; Prevention program; Primary Health Care; Primary Prevention; Process; Provider; Psychological Stress; Psychological reinforcement; Qualitative Research; Race; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Research; Rest; Risk; Risk Factors; Rural; Sampling; Secondary Prevention; Self Determination; Series; Site; Sleep; Specific qualifier value; Staging; Stress; Suggestion; Sympathetic Nervous System; Technology; Telephone; Testing; Time; alpha-amylase; arm; base; behavior change; biobehavior; blood pressure regulation; cardiovascular disorder risk; clinical practice; depressive symptoms; design; dosage; functional improvement; health disparity; hypothalamic-pituitary-adrenal axis; improved; mindfulness; post intervention; practice-based research network; primary outcome; programs; prototype; psychologic; public health relevance; racial and ethnic; satisfaction; secondary outcome; social; standard of care; success; theories; therapy development; trial comparing; usability

DESCRIPTION (provided by applicant): Stage 2 pre essential hypertension (preEH; 130-139/<90 mmHg) entails a 3-fold risk of developing EH and 2- fold risk of cardiovascular disease (CVD) events compared to those with optimal blood pressure (<120/80 mmHg). Prevention programs are needed which can be sustained by preEHs and readily disseminated by healthcare providers. Psychological stress is a risk factor for future EH and CVD. Stress reduction via meditation has shown promise in reducing blood pressure (BP) but adult studies have not determined optimal dosage level nor evaluated dosage adherence objectively. Multiple underlying biobehavioral mechanisms linking meditation with BP reduction also require additional scrutiny. The proposed research will address these issues by further developing and optimizing a smart phone breathing awareness meditation program (Tension Tamer:TT). Stage 2 preEH 21-50 year old African Americans and Whites balanced by geographical locale (urban vs. rural) and healthcare providers from 12 practice sites (6 urban/6 rural with 12,843 stage 2 preEHs) within the OQUIN practice based research network will be enrolled. The 3 stage process of intervention development specified in PA-11-063 will involve: 1) Optimization of TT content and delivery formats guided by behavioral and technological theories using 6 focus groups of OQUIN healthcare providers and 6 focus groups with preEHs (8 preEHs per group); 2) 6 month TT proof of concept study (n=60 stage 2 preEHs) to establish dosage tolerability and impact upon resting and 24 hour SBP and biobehavioral mechanisms: worry, rumination, anxiety, hostility, mindfulness, sleep, physical activity, sympathetic nervous system (SNS) and hypothalamic pituitary adrenal axis (HPA) activity; 3) 12 month 2-arm randomized control trial (RCT; TT vs enhanced standard of care smart phone health education program; total n=80) to generate estimates needed for design of a large scale RCT. This series of iterative studies, implemented and guided by healthcare providers and their preEH patients, will result in an intervention acceptable to multiple racial/ethnic groups in both urban and rural settings, feasible to conduct in clinical practice settings, effective in reducing SBP in a pilot RCT and ready for a large scale RCT.

描述（由申请人提供）：与最佳血压（<120/80 mmHg）相比，2期原发性高血压前期（preEH; 130-139/<90 mmHg）发生EH的风险为3倍，心血管疾病（CVD）事件风险为2倍。预防方案是必要的，这些方案可以由preEHs维持，并易于由医疗保健提供者传播。心理压力是未来EH和CVD的危险因素。通过冥想减轻压力已显示出降低血压的希望，但成人研究尚未确定最佳剂量水平，也未客观评估剂量依从性。将冥想与血压降低联系起来的多种潜在生物行为机制也需要进一步的审查。拟议的研究将通过进一步开发和优化智能手机呼吸意识冥想程序（Tension Tamer:TT）来解决这些问题。在OQUIN基于实践的研究网络中，21-50岁的非裔美国人和白人按地理位置（城市与农村）和来自12个实践点（6个城市/6个农村，12,843个阶段preEHs）的医疗保健提供者进行平衡。PA-11-063中规定的三个阶段的干预发展过程将包括：1)在行为和技术理论的指导下，使用6个OQUIN医疗保健提供者焦点小组和6个preEHs焦点小组（每组8个preEHs）优化TT内容和交付形式；2)为期6个月的TT概念验证研究（n=60例2期preEHs），以确定剂量耐受性、对静息和24小时收压的影响以及生物行为机制：担忧、反思性、焦虑、敌意、正力、睡眠、身体活动、交感神经系统（SNS）和下丘脑-垂体-肾上腺轴（HPA）活动；3) 12个月的2组随机对照试验（RCT； TT vs增强护理标准智能手机健康教育计划；总n=80），以产生设计大规模RCT所需的估计。这一系列的反复研究，由医疗保健提供者及其pre - eh患者实施和指导，将导致城市和农村环境中多种族/族裔群体可接受的干预措施，可行