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Mind Your Heart Intervention for American Indian Women

对美国印第安妇女进行心脏干预

基本信息

批准号：
10655474
负责人：
Jada L Brooks
金额：
$ 15.62万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-20 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10655474
关键词：
Address Age Age Years American Indians Area Attention Blood Pressure Buffers Cardiac health Cardiovascular Diseases Categories Cessation of life Characteristics Clinical Trials Clinical Trials Design Communities Control Groups Coping Skills Data Data Collection Death Rate Diet Discrimination Disparate Elements Enrollment Exclusion Exercise Foundations Future Goals Health Health Benefit Health Personnel Health Promotion Health Promotion and Education Health behavior Health education Heart Indigenous Informal Social Control Infrastructure Injury Institutional Review Boards Intervention Life Longevity Manuals Metabolic Methodology Methods Mind Modeling National Heart, Lung, and Blood Institute Non-Insulin-Dependent Diabetes Mellitus North Carolina Obesity Outcome Overweight Pilot Projects Post-Traumatic Stress Disorders Poverty Premature Mortality Preparation Procedures Process Protocols documentation Psychosocial Factor Psychosocial Stress Quality of Care Race Randomized Randomized, Controlled Trials Recording of previous events Reporting Research Research Personnel Risk Sample Size Sampling Self Efficacy Stress Testing Time Trauma Tribes Underserved Population Vulnerable Populations Waiting Lists Well in self Woman Work acceptability and feasibility cardiovascular disorder risk cardiovascular health clinical trial protocol community based participatory research community intervention cost cultural values data management design efficacy trial evidence base experience feasibility testing group intervention heart rate variability improved inflammatory marker innovation instrument intervention mapping intervention refinement men mindfulness mindfulness-based stress reduction mortality operation premature prevent programs psychologic recruit retention rate secondary outcome skills training stress management stress reduction stressor therapy design trial planning young woman

项目摘要

PROJECT SUMMARY/ABSTRACT Premature deaths due to cardiovascular disease (CVD) are increasing among American Indian women. Using a collaborative intervention planning approach that blends community-based participatory research (CBPR) principles and Intervention Mapping, we will implement a 3-year clinical trial planning project to adapt and investigate the feasibility, acceptability, and initial efficacy of a multi-component cardiovascular health promotion pilot intervention for American Indian women living in the southeast. First, we will adapt Mind Your Heart – an intervention with cardiovascular health education, mindfulness self-regulation, and coping skills training – culturally through qualitative formative research involving Talking Circles and Intervention Mapping with American Indian women ages 18-50 at risk for CVD, tribal citizens, and American Indian healthcare providers and traditional healers. Second, we will conduct a randomized controlled pilot study to examine feasibility, acceptability, and initial efficacy of the adapted Mind Your Heart intervention in American Indian women at risk for CVD. Third, we will refine the study infrastructure and intervention, obtain tribal and institutional review board approval, modify recruitment and retention strategies, develop a Clinical Trials Protocol, develop a Manual of Operations, and refine data collection and management procedures. Accomplishing these aims would provide the foundation for a future R01 clinical trial that directly aligns with the National Heart, Lung, and Blood Institute's scientific focus area of promoting cardiovascular health and preventing CVD across the lifespan. Preliminary evidence on the acceptability and feasibility of the adapted Mind Your Heart intervention for American Indian women would support the design and execution of a future R01 clinical trial to evaluate its efficacy. Our long- term goal is to develop a sustainable cardiovascular health program that promotes positive psychological well- being in American Indian women to prevent premature mortality from CVD.

项目总结/摘要在美洲印第安妇女中，由于心血管疾病（CVD）导致的过早死亡正在增加。使用协作干预规划方法，融合了基于社区的参与性研究（CBPR）原则和干预映射，我们将实施一个为期3年的临床试验规划项目，以适应和调查多成分心血管健康促进的可行性、可接受性和初步疗效对居住在东南部的美洲印第安妇女进行试点干预。首先，我们将调整你的心-一个心血管健康教育、正念自我调节和应对技能培训的干预- 通过涉及谈话圈和干预映射的定性形成性研究， 18-50岁的美国印第安妇女有CVD风险，部落公民和美国印第安人医疗保健提供者和传统的治疗师第二，我们会进行一项随机对照试验研究，以探讨可行性，在美国印第安妇女中进行适应性“关心你的心”干预的可接受性和初步疗效对于CVD。第三，我们将细化研究基础设施和干预措施，获得部落和机构审查委员会批准，修改招募和保留策略，制定临床试验方案，制定业务，并完善数据收集和管理程序。实现这些目标将提供未来R 01临床试验的基础，直接与国家心脏，肺和血液研究所的促进心血管健康和预防心血管疾病的科学重点领域。初步关于美国印第安人适应"关心你的心“干预的可接受性和可行性的证据妇女将支持未来R 01临床试验的设计和执行，以评估其疗效。我们长久以来- 长期目标是制定一个可持续的心血管健康计划，促进积极的心理健康，在美国印第安妇女中预防CVD过早死亡。