SMARThealth PRegnancy And Mental Health study: protocol for a situational analysis of perinatal mental health in women living in rural India.

Introduction: The situation for women experiencing mental health problems during pregnancy and postpartum in rural India is critical: a high burden of disease, a high estimated number of women are undiagnosed and untreated with mental health problems, a substantial gap in research on women's perinatal health, and severe stigma and discrimination. The SMARThealth Pregnancy study is a cluster randomised trial using a digital intervention to identify and manage anaemia, hypertension, and diabetes in the first year after birth in rural India. Within this study, the SMARThealth Pregnancy and Mental Health (PRAMH) study is a situational analysis to understand mental health problems during pregnancy and in the first year following birth in this population. Methods/design: This situational analysis aims to analyse and to assess the context of perinatal mental health, health services, barriers, facilitators, and gaps in Siddipet district of Telangana state in India, to develop an implementation framework for a future intervention. A tested, standardised situational analysis tool will be adapted and applied to perinatal mental health in rural India. A desktop and policy review will be conducted to identify and analyse relevant mental health and pregnancy care policies at the national and state levels. We will conduct in-depth interviews with policymakers, planners, mental health professionals and other experts in perinatal mental health (n = 10-15). We will also conduct focus group discussions with key stakeholders, including women with perinatal mental health problems, their families and carers, and community health workers (n = 24-40). A theory of change workshop with key stakeholders will be conducted which will also serve as a priority setting exercise, and will clarify challenges and opportunities, priorities, and objectives for a pilot intervention study. The analysis of qualitive data will be done using thematic analysis. Based on the data analysis and synthesis of the findings, an implementation framework will be developed to guide development, testing and scale up of a contextually relevant intervention for perinatal mental health. Discussion: The situational analysis will help to establish relationships with all relevant stakeholders, clarify the context and hypotheses for the pilot intervention and implementation.

A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial.

BACKGROUND: Medical complications during pregnancy, including anaemia, gestational diabetes mellitus and hypertensive disorders of pregnancy place women are at higher risk of long-term complications. Scalable and low-cost strategies to integrate non-communicable disease screening into pregnancy care are needed. We aim to determine the effectiveness and implementation components of a community-based, digitally enabled approach, "SMARThealth Pregnancy," to improve health during pregnancy and the first year after birth. METHODS: A pragmatic, parallel-group, cluster randomised, type 2 hybrid effectiveness-implementation trial of a community-based, complex intervention in rural India to decrease anaemia (primary outcome, defined as haemoglobin < 12g/dL) and increase testing for haemoglobin, glucose and blood pressure (secondary outcomes) in the first year after birth. Primary Health Centres (PHCs) are the unit of randomisation. PHCs are eligible with (1) > 1 medical officer and > 2 community health workers; and (2) capability to administer intravenous iron sucrose. Thirty PHCs in Telangana and Haryana will be randomised 1:1 using a matched-pair design accounting for cluster size and distance from the regional centre. The intervention comprises (i) an education programme for community health workers and PHC doctors; (ii) the SMARThealth Pregnancy app for health workers to support community-based screening, referral and follow-up of high-risk cases; (iii) a dashboard for PHC doctors to monitor high-risk women in the community; (iv) supply chain monitoring for consumables and medications and (v) stakeholder engagement to co-develop implementation and sustainability pathways. The comparator is usual care with additional health worker education. Secondary outcomes include implementation outcomes assessed by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance), clinical endpoints (anaemia, diabetes, hypertension), clinical service delivery indicators (quality of care score), mental health and lactation practice (PHQ9, GAD7, EuroQoL-5D, WHO IYCF questionnaire). DISCUSSION: Engaging women with screening after a high-risk pregnancy is a challenge and has been highlighted as a missed opportunity for the prevention of non-communicable diseases. The SMARThealth Pregnancy trial is powered for the primary outcome and will address gaps in the evidence around how pregnancy can be used as an opportunity to improve women's lifelong health. If successful, this approach could improve the health of women living in resource-limited settings around the world. TRIAL REGISTRATION: ClinicalTrials.gov NCT05752955. Date of registration 3 March 2023.

A Mobile Clinical Decision Support System for High-Risk Pregnant Women in Rural India (SMARThealth Pregnancy): Pilot Cluster Randomized Controlled Trial.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in women in India. Early identification is crucial to reducing deaths. Hypertensive disorders of pregnancy (HDP) and gestational diabetes mellitus (GDM) carry independent risks for future CVD, and antenatal care is a window to screen and counsel high-risk women. In rural India, community health workers (CHWs) deliver antenatal and postnatal care. We developed a complex intervention (SMARThealth Pregnancy) involving mobile clinical decision support for CHWs and evaluated it in a pilot cluster randomized controlled trial (cRCT). OBJECTIVE: The aim of the study is to co-design a theory-informed intervention for CHWs to screen, refer, and counsel pregnant women at high risk of future CVD in rural India and evaluate its feasibility and acceptability. METHODS: In phase 1, we used qualitative methods to explore community priorities for high-risk pregnant women in rural areas of 2 diverse states in India. In phase 2, informed by behavior change theory and human-centered design, we used these qualitative data to develop the intervention components and implementation strategies for SMARThealth Pregnancy in an iterative process with end users. In phase 3, using mixed methods, we evaluated the intervention in a cRCT with an embedded qualitative substudy across 4 primary health centres: 2 in Jhajjar district, Haryana, and 2 in Guntur district, Andhra Pradesh. RESULTS: SMARThealth Pregnancy embedded a total of 15 behavior change techniques and included (1) community awareness programs; (2) targeted training, including point-of-care blood pressure and hemoglobin measurement; and (3) mobile clinical decision support for CHWs to screen women in their homes. The intervention focused on 3 priority conditions: anemia, HDP, and GDM. The evaluation involved a total of 200 pregnant women, equally randomized to intervention or enhanced standard care (control). Recruitment was completed within 5 months, with minimal loss to follow-up (4/200, 2%) at 6 weeks postpartum. A total of 4 primary care doctors and 54 CHWs in the intervention clusters took part in the study. Fidelity to intervention practices was 100% prepandemic. Over half the study population was affected by moderate to severe anemia at baseline. The prevalence of HDP (2.5%) and GDM (2%) was low in our study population. Results suggest a possible improvement in mean hemoglobin (anemia) in the intervention group, although an adequately powered trial is needed. The model of home-based care was feasible and acceptable for pregnant or postpartum women and CHWs, who perceived improvements in quality of care, self-efficacy, and professional recognition. CONCLUSIONS: SMARThealth Pregnancy is an innovative model of home-based care for high-risk pregnant women during the transitions between antenatal and postnatal care and adult health services. The use of theory and co-design during intervention development facilitated acceptability of the intervention and implementation strategies. Our experience has informed the decision to initiate a larger-scale cRCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT03968952; https://clinicaltrials.gov/ct2/show/NCT03968952. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3389/fgwh.2021.620759.

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.

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.