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.

项目摘要和摘要 到2045年，大多数新的糖尿病病例将发生在印度等低收入和中等收入国家（LMIC）， 但是，受苦的人中有50％不知道。改善妊娠女性的产后糖尿病筛查 糖尿病（GDM） - 进展为2型糖尿病（T2DM）的高风险标志 - 可以帮助关闭这一点 诊断差距。这在印度尤为重要，那里很少有GDM女性接受产后T2DM 筛查，即使在产后第一年内GDM患有GDM的女性中有25％的妇女。改进 在怀孕和产后的关键生活阶段进行T2DM筛查将有助于防止后遗症 未经治疗的糖尿病，包括心血管疾病，这是印度妇女死亡的主要原因。 我们与Deep Griha协会和爱德华国王纪念医院研究中心合作，我们提出了 II型混合有效性 - 实现集群随机试验，以评估社区卫生工作者是否存在 （CHW）可以改善印度浦那城市贫民窟的产后T2DM筛查。我们将筛选怀孕 怀孕期间，居住在印度贫民窟社区中的GDM的妇女。贫民窟社区将是 等同于两个研究臂之一的随机数：（1）家庭测试部门，其中女性 将为GDM提供WHO征用的口服葡萄糖耐受性测试，以用于其家中的T2DM筛查； （2）转介臂，其中具有GDM的妇女将被转诊以用于基于诊所的产后T2DM筛查。 通过混合方法，我们将确定CHW服务的影响对 产后T2DM测试以及与干预实施有关的因素。我们的具体目的是： 1。确定产后T2DM在家庭测试与推荐臂的摄取 在印度浦那的GDM的妇女中。主要结果是吸收产后T2DM 在患有GDM的女性中进行筛查。我们假设家庭测试部门中有70％的妇女会接受 在产后一年内对T2DM进行筛查，而转介臂则为45％ 2。使用收敛的混合方法研究评估CHW分配程序的实施 设计和实施研究的合并框架（CFIR）。我们将收集 来自AIM 1的AIM 1参与者的定性和定量数据在两个研究组中以及 CHW，临床人员和卫生官员，系统地评估CFIR领域。 这将是第一项确定受过训练的CHW是否可以改善Urban中Urban中T2DM筛查的研究 印度贫民窟。这项研究的结果将改善产后T2DM筛查的吸收，识别低收入 印度产后T2DM风险最高的妇女，并有可能确定改善的新方法 与NIH PAR-22-132一致的低收入和中等收入国家的其他疾病的产后筛查。