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
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
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.
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.
Date Issued
2023-08-09
Date Acceptance
2023-07-12
Citation
Trials, 2023, 24, pp.1-17
ISSN
1745-6215
Publisher
BMC
Start Page
1
End Page
17
Journal / Book Title
Trials
Volume
24
Copyright Statement
© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or
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to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this
licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco
mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or
other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line
to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this
licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco
mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
License URL
Identifier
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07510-x
Publication Status
Published
Article Number
510
Date Publish Online
2023-08-09