Accepted for/Published in: JMIR Formative Research
Date Submitted: Nov 17, 2022
Open Peer Review Period: Nov 16, 2022 - Dec 19, 2022
Date Accepted: Jun 13, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
SMARThealth Pregnancy: A pilot cluster randomised trial in rural India to assess the feasibility and acceptability of a complex intervention using mobile clinical decision support for community health workers to screen, refer and counsel pregnant women at high risk of future cardiometabolic disorders.
ABSTRACT
Background:
Hypertensive Disorders of Pregnancy (HDP) and Gestational Diabetes Mellitus (GDM) carry independent risks for future cardiometabolic disorders (CMDs), including Type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) - the leading cause of death in women in India. Two-thirds of the population live in rural areas, with limited health service access. Early identification of high-risk women is crucial to reducing CVD deaths. We conducted in-depth contextual work in rural areas of two diverse States in India to design a complex intervention (SMARThealth Pregnancy), using mobile clinical decision support for Community Health Workers (CHWs) to screen, refer and counsel pregnant women at high risk of future CMDs. The intervention was informed by behaviour change theory and embedded 15 behaviour change techniques.
Objective:
To assess the intervention’s feasibility and acceptability.
Methods:
We piloted the intervention in a prospective unblinded cluster randomised controlled trial (cRCT), embedding a qualitative sub-study. Four Primary Health Centres (PHCs): two in Jhajjar district, Haryana, and two in Guntur district, Andhra Pradesh, were randomised to intervention or control (enhanced standard care) groups. CHWs based at the intervention PHCs underwent targeted education and training, focusing on three priority conditions: anaemia in pregnancy, HDP and GDM, identified by key stakeholders within the study districts.
Results:
Two hundred pregnant women, equally randomised to intervention (n=100) and control (enhanced standard care, n=100), were recruited within 5 months across all study sites, with minimal loss to follow-up (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% pre-pandemic. Baseline prevalence of moderate-severe anaemia in both intervention and control groups was high (47% and 58% of women, respectively). Prevalence of HDP (2.5%) and GDM (2%) was low in our study population. CHWs and pregnant/postpartum women found the SMARThealth Pregnancy intervention acceptable, easy to use, and perceived improvements in the quality of antenatal and postnatal care and their self-efficacy.
Conclusions:
SMARThealth Pregnancy is feasible and acceptable for CHWs to screen, refer and counsel pregnant women at high risk of future CMDs. Mobile clinical decision support for CHWs in rural India is as a useful method of task-sharing and health system strengthening and provides a model of integrated care during the transitions between antenatal, postnatal care and adult health services. Furthermore, the intervention has provided opportunities for home-based care for pregnant and postpartum women during the pandemic. Our experience has informed the decision to initiate a larger scale cRCT. Clinical Trial: Trial Registration: ClinicalTrials.gov (NCT03968952).
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.