Evidence mapPaperPMID 41769783Full record

ArticleWomen's health (London, England)

Protocol for a process and implementation evaluation of the SMARThealth pregnancy hybrid type 2 cluster randomised controlled trial.

Nicole Votruba, Sreya Majumdar, Sudhir Thout Raj, Vaaruni Nayak, Ankita Sharma, David Peiris, Hueiming Liu, Varun Arora, Minakshi Verma, Mohammad Abdul Ameer and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Women's health (London, England). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

12 authors.

Nicole VotrubaNuffield Department of Women's & Reproductive Health, University of Oxford, UK.ORCID 0000-0003-0680-1290
Sreya MajumdarThe George Institute for Global Health, New Delhi, India.
Sudhir Thout RajThe George Institute for Global Health, New Delhi, India.
Vaaruni NayakThe George Institute for Global Health, Imperial College, London, UK.
Ankita SharmaNuffield Department of Women's & Reproductive Health, University of Oxford, UK.
David PeirisThe George Institute for Global Health, University of New South Wales, Australia.
Hueiming LiuThe George Institute for Global Health, University of New South Wales, Australia.
Varun AroraPGIMS Rohtak, Haryana, India.
Minakshi VermaThe George Institute for Global Health, New Delhi, India.
Mohammad Abdul AmeerThe George Institute for Global Health, New Delhi, India.
Devarsetty PraveenThe George Institute for Global Health, New Delhi, India.
Jane E HirstNuffield Department of Women's & Reproductive Health, University of Oxford, UK.ORCID 0000-0002-0176-2651

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis protocol outlines the process and implementation evaluation of the SMARThealth Pregnancy (SHP) pragmatic, type 2 hybrid cluster randomised trial conducted in two states in India (Haryana/Telangana). The SHP trial aims to improve the community-level identification, diagnosis, referral and management of women with anaemia, diabetes, and hypertension during pregnancy and in the year after birth.

objectivesThe process and implementation evaluation aims to understand how, why, and for whom the SHP intervention may be effective (or not). It aims to identify contextual factors, barriers, and facilitators relevant to the implementation of the intervention, and understand mechanisms and strategies employed during its implementation.

designThe study utilised a process evaluation design.

methodA mixed methods evaluation drawing from realist evaluation, normalisation process theory, the Medical Research Council framework, reach, effectiveness, adoption, implementation and maintenance framework, and Proctor's typology will be employed for understanding the implementation process. The evaluation will involve focus group discussions and semi-structured interviews with healthcare providers (Accredited Social Health Activist, primary care doctors, and auxiliary nurse midwife), women, and field staff. Quantitative process data describing reach, fidelity, dose, and adoption of intervention will be collected. Observations of trial setup and implementation will be conducted. Both qualitative and quantitative data will be analysed iteratively before the effectiveness outcomes of the SHP trial are available and will subsequently be triangulated with the trial primary outcome evaluation data. DISCUSSION: The findings from this process evaluation will provide an understanding of how the intervention works in practice, its potential to detect and manage anaemia, diabetes and hypertension during pregnancy and in the year after birth, and its scalability as an integrated model for the management of non-communicable diseases in pregnancy/postnatal care.

Indexed as

AnemiaPregnancy ComplicationsPrenatal CareDigital HealthFemaleFocus GroupsHumansHypertensionIndiaMaternal Health ServicesPregnancyRandomized Controlled Trials as TopicResearch DesignTelemedicineanaemiaclinical decision supportcommunity health workerscomplex interventiongestational diabetesmaternal healthmHealthnon-communicable diseasespreeclampsiarural India

Identifiers

PMID41769783
PMCPMC12954037

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.