A type 2 hybrid effectiveness-implementation trial of Community Health Workers to improve screening for postpartum diabetes in urban slums of India

对社区卫生工作者进行的 2 型混合有效性实施试验，以改善印度城市贫民窟的产后糖尿病筛查

• 批准号: 10672685
• 负责人: Jyoti S Mathad
• 金额: $ 65.81万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-18 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10672685
• 关键词: Affect; Cardiovascular Diseases; Caring; Cause of Death; Chronic Disease; Clinic; Clinical; Cluster randomized trial; Communities; Community Health Aides; Complications of Diabetes Mellitus; Consolidated Framework for Implementation Research; Counseling; Country; Data; Diabetes Mellitus; Diagnosis; Diagnostic; Disease; Early Diagnosis; Ensure; Fasting; Foundations; Funding; Gestational Diabetes; Glucose; Goals; Government; Health; High Risk Woman; Home; Hospitals; Hour; Hybrids; Incidence; India; Intervention; Interview; Knowledge; Life; Link; Longitudinal cohort study; Low income; Maternal Health; Methods; Modeling; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Oral; Participant; Pilot Projects; Population; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Prevalence; Prevention; Random Allocation; Randomized; Recommendation; Records; Research; Research Design; Services; Slum; Societies; Structure; Surveys; Testing; Training; Trust; United States National Institutes of Health; Urban Community; Woman; World Health Organization; adverse outcome; antenatal; arm; clinical care; effectiveness/implementation trial; experience; high risk; high risk population; home test; implementation determinants; implementation evaluation; implementation framework; implementation intervention; implementation outcomes; implementation science; implementation/effectiveness; improved; low and middle-income countries; member; mortality; novel strategies; post implementation; prevent; primary outcome; programs; progression risk; retention rate; screening; secondary analysis; testing uptake; two-arm study; underserved community; uptake; urban Native American

PROJECT SUMMARY & ABSTRACT By 2045, most of the new cases of diabetes will occur in low- and middle- income countries (LMIC) like India, but 50% of those afflicted will not know. Improving postpartum diabetes screening for women with gestational diabetes (GDM) – a marker of high risk for progression to type 2 diabetes (T2DM) – can help close this diagnostic gap. This is particularly important in India, where few women with GDM receive postpartum T2DM screening, even though 25% of women with GDM develop T2DM within the first year postpartum. Improving T2DM screening during the critical life stages of pregnancy and postpartum will help prevent the sequelae of untreated diabetes, including cardiovascular disease, the leading cause of death among Indian women. In partnership with the Deep Griha Society and King Edward Memorial Hospital Research Center, we propose a hybrid type II effectiveness-implementation cluster randomized trial to evaluate if community health workers (CHW) can improve postpartum T2DM screening in the urban slums of Pune, India. We will screen pregnant women living in slum communities in India for GDM during pregnancy. The slum communities will be randomized in equal number to one of two study arms: (1) the home-based testing arm, where women with GDM will be offered the WHO-recommended oral glucose tolerance test for T2DM screening in their homes; and (2) the referral arm, where women with GDM will be referred for clinic-based postpartum T2DM screening. Through a mixed-methods approach, we will determine the impact of CHW-delivered services on the uptake of postpartum T2DM testing as well as factors pertaining to intervention implementation. Our specific aims are to: 1. Determine the uptake of postpartum T2DM screening in home testing versus referral arms among women with GDM in Pune, India. The primary outcome is uptake of postpartum T2DM screening in women with GDM. We hypothesize that 70% of women in the home testing arm will accept screening for T2DM within one-year postpartum compared to 45% in the referral arm 2. Evaluate implementation of the CHW-delivered programs using a convergent, mixed methods study design and the Consolidated Framework for Implementation Research (CFIR). We will collect qualitative and quantitative data from Aim 1 participants with GDM in both study arms, as well as from CHW, clinical staff, and Ministry of Health Officials to systematically evaluate CFIR Domains. This will be the first study to determine if trained CHW can improve postpartum T2DM screening in urban Indian slums. The results of this study will improve uptake of postpartum T2DM screening, identify low-income women at the highest risk of postpartum T2DM in India, and potentially identify novel approaches for improving postpartum screening for other diseases in low- and middle-income countries, in line with the NIH PAR-22-132.

项目概要和摘要 到 2045 年，大多数新发糖尿病病例将发生在印度等低收入和中等收入国家 (LMIC)， 但 50% 的患者不知道如何改善妊娠期女性的产后糖尿病筛查。 糖尿病 (GDM)——进展为 2 型糖尿病 (T2DM) 高风险的标志物——可以帮助解决这一问题 这在印度尤为重要，因为印度很少有 GDM 女性会出现产后 T2DM。 筛查，尽管 25% 的 GDM 女性在产后第一年内发展为 T2DM。 在怀孕和产后的关键生命阶段进行 T2DM 筛查将有助于预防后遗症 未经治疗的糖尿病，包括心血管疾病，是印度女性死亡的主要原因。 我们与 Deep Griha Society 和爱德华国王纪念医院研究中心合作，建议 一项混合 II 型有效性实施集群随机试验，旨在评估社区卫生工作者是否 (CHW) 可以改善印度浦那城市贫民窟的产后 T2DM 筛查 我们将对孕妇进行筛查。 居住在印度贫民窟社区的妇女在怀孕期间会发生 GDM。 随机分配到两个研究组之一：(1) 家庭测试组，其中患有以下疾病的女性 GDM 将接受世界卫生组织推荐的口服葡萄糖耐量测试，以便在家中进行 T2DM 筛查； (2) 转诊部门，患有 GDM 的女性将被转诊进行基于临床的产后 T2DM 筛查。 通过混合方法，我们将确定社区卫生工作者提供的服务对采用的影响 产后 T2DM 测试以及与干预实施相关的因素我们的具体目标是： 1. 确定家庭测试与转诊组中产后 T2DM 筛查的采用情况 印度浦那患有 GDM 的女性的主要结果是产后 T2DM 的发生率。 我们勇敢地说，家庭检测部门中 70% 的女性会接受。 产后一年内筛查 T2DM，而转诊组的筛查率为 45% 2. 使用聚合、混合方法研究评估社区卫生工作者提供的计划的实施情况 我们将收集设计和实施研究综合框架（CFIR）。 来自两个研究组中患有 GDM 的 Aim 1 参与者以及来自 社区卫生工作者、临床工作人员和卫生部官员系统地评估 CFIR 领域。 这将是第一项确定经过培训的社区卫生工作者是否可以改善城市产后 T2DM 筛查的研究 印度贫民窟的这项研究结果将提高产后 T2DM 筛查的普及率，识别低收入人群。 印度女性患产后 T2DM 的风险最高，并有可能找到改善的新方法 根据 NIH PAR-22-132，在低收入和中等收入国家对其他疾病进行产后筛查。