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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：
10514983
负责人：
William Checkley
金额：
$ 142.27万
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 2027-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10514983
关键词：
Acceleration Address Adoption Adult Affect Altitude Andean Awareness Behavior Therapy Behavioral Blood Pressure Caring Chronic Care Clinical Clinical Research Clinical Trials Cluster randomized trial Collaborations Communities Community Health Community Health Aides Community Healthcare Consolidated Framework for Implementation Research Country Data Detection Diabetes Mellitus Diagnosis Diet Educational workshop Effectiveness Enrollment Ensure Epidemic Epidemiology Event Health Health Fairs Health Resources Health system High Prevalence Hypertension Indigenous Individual Intervention Intervention Trial Interview Investments Link Measures Methods Modeling Monitor Morbidity - disease rate Non-Insulin-Dependent Diabetes Mellitus Outcome Patients Persons Peru Peruvian Pharmaceutical Preparations Phase Policies Policy Maker Population Positioning Attribute Poverty Probability Samples Process Public Health Qualitative Methods Randomized Research Rural Savings Service delivery model Services Shapes Surveys System Testing Time Tuberculosis Vulnerable Populations aged barrier to care blood pressure reduction burden of illness community based care community based service community intervention cost cost effectiveness cost-effectiveness evaluation dietary disability-adjusted life years effectiveness evaluation experimental study follow-up health care settings health service use high risk human centered design hypertension control hypertension treatment implementation evaluation implementation fidelity implementation outcomes implementation science implementation strategy implementation/effectiveness innovation low and middle-income countries models and simulation mortality multi-component intervention patient engagement patient population pragmatic trial primary outcome response scale up secondary outcome service delivery success treatment as usual trial design usability

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.

项目总结/文摘