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Abstract
Background
Non-communicable diseases (NCDs) cause 4.7 million deaths annually in India. Floods increasingly disrupt NCD care, especially in Bihar, one of India’s most flood-prone and socioeconomically disadvantaged states. This study aims to strengthen the capacity of the community and primary healthcare systems to improve NCD outcomes during annual flooding in Bihar.
Methods
We describe a type II, hybrid implementation-effectiveness parallel cluster randomised controlled trial with an embedded qualitative process evaluation. A multi-component, co-developed intervention targeting primary care and community settings will be implemented and evaluated over two flood seasons in 26 flood-prone community development blocks in three districts of Bihar. Normalisation Process Theory (NPT) will guide the interpretation and adaptation of the intervention for broader applicability. Data will be collected through baseline and follow-up cross-sectional surveys conducted immediately after and 6 months following each annual flood season. Mixed-methods implementation and effectiveness outcomes will be evaluated using the RE-AIM-QuEST (Reach, Effectiveness, Adoption, Implementation, and Maintenance, Qualitative Evaluation for Systematic Translation) framework. Co-primary outcomes are patient medication adherence and availability of a flood-proof kit with medication and clinical handover information during floods. A preliminary health economic evaluation will estimate the cost-effectiveness of the intervention from a healthcare and societal perspective, with and without the use of early-warning flood forecasting.
Conclusion
The FUSION (Floods, UnderStanding clImate change and nON communicable disease) trial will generate evidence on effective and scalable strategies to enhance health system and community resilience for the continuity of NCD care during recurrent flooding in India. Findings will inform public health policy and disaster preparedness efforts in similar resource-constrained, climate-vulnerable settings.
Non-communicable diseases (NCDs) cause 4.7 million deaths annually in India. Floods increasingly disrupt NCD care, especially in Bihar, one of India’s most flood-prone and socioeconomically disadvantaged states. This study aims to strengthen the capacity of the community and primary healthcare systems to improve NCD outcomes during annual flooding in Bihar.
Methods
We describe a type II, hybrid implementation-effectiveness parallel cluster randomised controlled trial with an embedded qualitative process evaluation. A multi-component, co-developed intervention targeting primary care and community settings will be implemented and evaluated over two flood seasons in 26 flood-prone community development blocks in three districts of Bihar. Normalisation Process Theory (NPT) will guide the interpretation and adaptation of the intervention for broader applicability. Data will be collected through baseline and follow-up cross-sectional surveys conducted immediately after and 6 months following each annual flood season. Mixed-methods implementation and effectiveness outcomes will be evaluated using the RE-AIM-QuEST (Reach, Effectiveness, Adoption, Implementation, and Maintenance, Qualitative Evaluation for Systematic Translation) framework. Co-primary outcomes are patient medication adherence and availability of a flood-proof kit with medication and clinical handover information during floods. A preliminary health economic evaluation will estimate the cost-effectiveness of the intervention from a healthcare and societal perspective, with and without the use of early-warning flood forecasting.
Conclusion
The FUSION (Floods, UnderStanding clImate change and nON communicable disease) trial will generate evidence on effective and scalable strategies to enhance health system and community resilience for the continuity of NCD care during recurrent flooding in India. Findings will inform public health policy and disaster preparedness efforts in similar resource-constrained, climate-vulnerable settings.
Trial registration
CTRI/2025/07/092055 [Registered on 30/07/2025] http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=138142; ISCTRN18019775 [Registered on 12/08/2025] https://www.isrctn.com/ISRCTN18019775.
| Original language | English |
|---|---|
| Journal | Trials |
| DOIs | |
| Publication status | Published - 31 Mar 2026 |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being -
SDG 13 Climate Action
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Dive into the research topics of 'Improving primary healthcare for non-communicable diseases during annual flooding in Bihar, India: study protocol for a hybrid implementation-effectiveness parallel cluster randomised controlled trial'. Together they form a unique fingerprint.Projects
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Improving primary healthcare for patients with non-communicable diseases during severe flooding in India
Manaseki-Holland, S. (Principal Investigator), Hemming, K. (Co-Investigator), Sitch, A. (Co-Investigator), Jowett, S. (Co-Investigator), Greenfield, S. (Co-Investigator), Han, S. (Co-Investigator), Nirantharakumar, K. (Co-Investigator), Hall, J. (Co-Investigator), Blackburn, S. (Co-Investigator), Widmann, M. (Co-Investigator), Jordan, R. (Co-Investigator) & Krause, S. (Co-Investigator)
1/01/24 → 31/12/28
Project: Other Government Departments
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