Addressing HyperteNsion and Diabetes through Community-Engaged Systems in Puno, Peru (ANDES study)

通过秘鲁普诺的社区参与系统解决高血压和糖尿病问题（ANDES 研究）

基本信息

批准号：
9974818
负责人：
William Checkley
金额：
$ 64.1万
依托单位：
UNIVERSIDAD PERUANA CAYETANO HEREDIA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-30 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9974818
关键词：
Address Adoption Adult Affect Altitude Andean Awareness Behavior Therapy Behavioral Blood Pressure Caring Chronic Care Clinical Clinical Research Clinical Trials Cluster randomized trial Collaborations Comb animal structure Communities Community Health Community Health Aides Country Data Detection Diabetes Mellitus Diagnosis Diet Educational workshop Effectiveness Enrollment Ensure Epidemic Epidemiology Event Health Health Fairs Health Resources Health system High Prevalence Human Hypertension Indigenous Individual Intervention Intervention Trial Interview Investments Link Logistics Measures Methods Modeling Monitor Morbidity - disease rate Non-Insulin-Dependent Diabetes Mellitus Outcome Patients Persons Peru Peruvian Pharmaceutical Preparations Phase Policies Population Positioning Attribute Probability Samples Process Public Health Qualitative Methods Randomized Research Rural Savings Service delivery model Services Shapes Structure Surveys System Testing Time Tuberculosis Vulnerable Populations aged barrier to care base blood pressure reduction burden of illness care costs community based care community based service community intervention cost cost effectiveness design disability-adjusted life years effectiveness evaluation experimental study follow-up health care settings health service use high risk hypertension control hypertension treatment implementation research implementation science implementation strategy innovation low and middle-income countries models and simulation mortality multi-component intervention patient population pragmatic trial primary outcome response scale up secondary outcome service delivery success treatment as usual trial design

项目摘要

PROJECT SUMMARY/ABSTRACT Hypertension (HTN) and has become the largest driver of morbidity and mortality (M&M) worldwide, affecting nearly 1 billion persons, the vast majority living in low- and middle-income countries (LMICs). While clinical research has identified highly-efficacious and inexpensive options to control HTN, rates of awareness, treatment and control of HTN are abysmally low. Implementation strategies that can effectively reach and engage patient populations while feasible within the constraints of frail health systems are urgently needed. In Peru, less than 10% of those with HTN are optimally controlled and thus avoidable M&M continues to increase at unacceptable levels. In the proposed ANDES strategy, we will study a vulnerable, impoverished indigenous Andean population that has a high prevalence of HTN (18.5%) and T2D (7.4%); living at high altitude (similar to ~140 million people worldwide–thus highly significant). The study has two phases: UG3/UH3. The formative UG3 phase (24 months) will draw from two implementation strategies: a) health fairs (HFs) that draw an entire community to an event using community mobilization and entertainment where HTN diagnoses can be rapidly made and linked to care, and b) community health worker (CHW)-based multicomponent intervention to overcome logistical and structural barriers to treatment. CHWs are used in LMIC for episodic conditions, but adaptations are required to effectively address HTN. We draw from the Consolidated Framework for Implementation Research to guide a formal adaptation process including using: a) key stakeholder qualitative interviews, b) discrete choice experiments, and c) human centered design to re-shape the HFs and CHWs to meet community needs and fit health system context. The UG3 phase will end with a 12-month pilot intervention of HF and CHWs in two communities focusing on implementation outcomes. The UH3 phase will test the adapted ANDES strategy in a cluster-randomized trial. We will enroll 1,608 individuals with HTN (with/without type 2 diabetes, T2D), aged 55-89 years, from 24 clusters (67 subjects/cluster); all 24 clusters receive the HFs, but 12 clusters will be randomized to a CHW-based multicomponent intervention (i.e., diet, behavioral, medications) vs. usual care in the other 12 clusters. We will assess the implementation, service delivery and clinical outcomes. The primary outcome is change in SBP at 12 months. Secondary outcomes include proportion of subjects with controlled HTN (SBP/DBP<140/90 mmHg) and controlled T2D (HgbA1c<7%). We will also assess implementation fidelity and adaptations, engagement in care, costs and early sustainability. We have assembled a strong research team from Peru and USA with a robust track record of collaboration and expertise in HTN, implementation science and clinical trials, and have partnered with the Peruvian Ministry of Health. We are uniquely positioned to advance the implementation science agenda to address HTN in Peru, a major stakeholder for the scale-up phase. The pragmatic trial design will provide rigorous and relevant evidence to inform national and global policies and subsequent intervention scaling-up.

项目概要/摘要高血压 (HTN) 已成为全球发病率和死亡率 (M&M) 的最大驱动因素，影响近 10 亿人，其中绝大多数生活在低收入和中等收入国家 (LMIC)。研究已经确定了控制 HTN、意识率、能够有效达到和控制高血压的实施策略非常低。迫切需要在卫生系统薄弱的限制下，在可行的情况下让患者群体参与进来。秘鲁，只有不到 10% 的 HTN 患者得到最佳控制，因此可避免的 M&M 继续增加在拟议的 ANDES 战略中，我们将研究脆弱、贫困的土著居民。居住在高海拔地区的安第斯人群高血压（18.5%）和二型糖尿病（7.4%）患病率较高；全球约 1.4 亿人——因此非常重要）。该研究分为两个阶段：UG3/UH3。 UG3 阶段（24 个月）将借鉴两种实施策略：a) 吸引整个群体的健康博览会 (HF) 社区参与利用社区动员和娱乐的活动，可以快速诊断 HTN b) 基于社区卫生工作者 (CHW) 的多成分干预克服后勤和结构性障碍来治疗中低收入国家的突发情况，但为了有效解决 HTN，需要进行调整，我们借鉴了《综合框架》。指导正式适应过程的实施研究，包括使用： a) 主要利益相关者定性访谈，b) 离散选择实验，以及 c) 以人为本的设计，以重塑 HF 和 CHW，满足社区需求并适应卫生系统背景 UG3 阶段将以 12 个月的试点结束。 UH3 阶段将重点关注两个社区的 HF 和 CHW 的干预。在整群随机试验中测试改编后的 ANDES 策略我们将招募 1,608 名 HTN 患者。（患有/不患有 2 型糖尿病，T2D），年龄 55-89 岁，来自 24 个组（所有 24 个组 67 名受试者）；接受 HF，但 12 个集群将被随机分配到基于 CHW 的多成分干预（即饮食、我们将评估其他 12 个集群的实施情况、服务。主要结果是 12 个月时收缩压的变化。包括高血压受控（SBP/DBP<140/90 mmHg）和 T2D 受控的受试者比例（HgbA1c<7%）我们还将评估实施的保真度和适应性、护理参与度、成本和我们组建了一支来自秘鲁和美国的强大研究团队，拥有良好的业绩记录。 HTN、实施科学和临床试验方面的合作和专业知识，并与秘鲁卫生部具有独特的优势，可以推动实施科学议程，以实现以下目标：秘鲁的 HTN 是扩大阶段的主要利益相关者，务实的试验设计将提供。为国家和全球政策以及随后扩大干预措施提供信息的严格且相关的证据。