SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial.
SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial.
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DOI：
10.3389/fgwh.2021.620759
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Hirst JE
中科院分区：
文献类型：
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作者：
Nagraj S;Kennedy SH;Jha V;Norton R;Hinton L;Billot L;Rajan E;Arora V;Praveen D;Hirst JE
导言：印度正处于流行病向非传染性疾病的重大转变过程中。心血管疾病（CVD）是印度妇女死亡的主要原因。诱发独立风险因素包括妊娠相关疾病，例如，妊娠期高血压疾病（HDP）和妊娠期糖尿病（GDM）-也与围产期死亡率和发病率显著相关。早期识别，转诊和管理孕妇在未来心血管疾病的风险增加可能提供预防的机会。在印度农村，社区卫生工作者提供大部分产前和产后护理。需要有创新的解决办法，以解决农村妇女在产前、产后和一般保健服务之间过渡期间的综合保健问题。乔治研究所的SMARThealth计划表明，印度农村的社区卫生工作者使用决策支持系统对非怀孕成年人进行心血管风险筛查是可行的。在此基础上，我们为社区卫生工作者制定了一项有针对性的培训计划，并制定了一项复杂的系统级干预措施，该措施使用移动的临床决策支持，为社区卫生工作者和初级保健医生筛查高危孕妇。除了解决HDP和GDM，干预措施还筛查妊娠贫血。方法/设计：试点研究将在印度的两个不同的农村地区：Jhajjar（哈里亚纳邦）和Guntur（安得拉邦）。将在每个研究中心将两个初级卫生中心集群随机分配至干预组或对照组。本初步研究的主要目的是探索SMARThealth妊娠干预的可行性和可接受性。次要目的是估计：（a）研究中心中度至重度贫血、HDPs和GDM的患病率;（B）转诊率和随访率，以及（c）常规产后6周访视时的平均血红蛋白和血压值。将使用定性方法进行过程评价，以探索SMARThealth妊娠干预对孕妇和医护人员的可接受性。讨论内容：预计这项试点研究的结果将有助于确定SMARThealth妊娠干预措施的可行性和可接受性，并强调如何进一步开发干预措施，以便在更大规模的随机分组对照试验中进行评估。临床试验注册：www.ClinicalTrials.gov，标识符：NCT 03968952。
Introduction: India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy. Methods/Design: A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods. Discussion: It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03968952.