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：
10470891
负责人：
Jada L Brooks
金额：
$ 23.39万
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/10470891
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 Clinical trial protocol document Cohort Effect Communities Control Groups Coping Skills Data Data Collection Death Rate Discrimination Elements Enrollment Foundations Future Goals Health Health Benefit Health Personnel Health Promotion 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 Randomized Randomized Controlled Trials Recording of previous events Research Research Personnel Risk Sample Size Sampling Self Efficacy Stress Testing Time Trauma Underserved Population Vulnerable Populations Waiting Lists Well in self Woman Work acceptability and feasibility base cardiovascular disorder risk cardiovascular health community based participatory research community intervention cost cultural values data management design diet and exercise efficacy trial evidence base experience feasibility testing group intervention healing heart rate variability improved inflammatory marker innovation instrument intervention mapping 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 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.

项目摘要/摘要美洲印度妇女的心血管疾病（CVD）导致的过早死亡正在增加。使用结合基于社区的参与研究（CBPR）的协作干预计划方法原则和干预映射，我们将实施一个为期3年的临床试验计划项目，以适应和研究多组分心血管健康促进的可行性，可接受性和初始效率居住在东南部的美洲印第安妇女的飞行员干预。首先，我们会适应您的心 - 干预心血管健康教育，正念自我调节和应对技能培训 - 通过定性形成性研究在文化上，涉及谈话圈子和干预映射 18-50岁的美国印第安妇女有CVD，部落公民和美洲印第安医疗保健提供者的风险和传统的治疗师。其次，我们将进行一项随机对照试验研究，以检查可行性，可接受性和适应性思维的最初效率您对处于危险中的美洲印第安妇女的心脏干预对于CVD。第三，我们将完善研究基础设施和干预，获得部落和机构审查委员会批准，修改招聘和保留策略，制定临床试验协议，制定手册操作，并完善数据收集和管理程序。完成这些目标将提供未来R01临床试验的基础，该试验直接与国家心脏，肺和血液研究所的相吻合促进心血管健康和防止CVD的科学重点领域。初步的关于适应性思维的可接受性和可行性的证据妇女将支持未来R01临床试验的设计和执行，以评估其有效性。我们的长期术语目标是制定可持续的心血管健康计划，以促进积极的心理健康在美洲印第安妇女中，以防止CVD过早死亡。