Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT02239250
Brief Summary:
DelAgua Health Rwanda (Implementation) Ltd. together with Rwanda Ministry of Health (MoH) are delivering an intervention, consisting on the free distribution of one advance water filter and one improved cookstove to all household classified as ubudehe 1 and 2 according to government approved registers (poorest tertile), in Western Province. The aim of this intervention is to reduce the morbidity and mortality associated with diarrhoeal diseases and pneumonia in Rwanda.
The London School of Hygiene and Tropical Medicine (LSHTM) will be undertaking an independent evaluation of this large-scale intervention to assess its impact on health. The trial will evaluate whether the provision of improved cookstoves and advance water filters can reduce pneumonia and diarrhoea disease in children under 5 years of age.
A cluster randomized controlled trial (CRCT) with two arms of unequal size (3:1 ratio) will be use to answer this question. The 96 sectors in Western Province, Rwanda, will be randomised to either receive the intervention or the control. Each eligible household in intervention sectors will receive one EcoZoom™ Spartan and one Vestergaard Frandsen Lifestraw Family™ 2.1 water filter free of charge. Eligible households in control sectors will continue with their traditional cooking and drinking practices. Health data on children under 5 years of age will be collected from community health worker (CHW) and health facility records all across Western Province to evaluate the health impact of the intervention. The study will encompass 12 months of follow-up. After this time the control sectors will receive the intervention.
This independent evaluation will also include a nested village-level study within the larger sector-level study, with the aim to evaluate uptake, consistent use and acceptability of the intervention, as well as to assess the impact on environmental exposures and health outcomes. 174 villages (74 controls and 74 intervention) will be selected for participation. Household surveys will be used to collect data on intervention use and acceptability as well as on self-reported health data. Water samples will be collected and monitoring of exposure to Households Air Pollution (HAP) will be undertaken. Measurements of blood pressure, expirated Carbon monoxide (CO) and pulse CO-oximetry will be undertake in primary cooks and or children under 5 years of age. Additionally, as part of this nested study, two exploratory studies will also be conducted. One will be focused on assessing the potential of biomarkers as indicators of environmental exposures (mainly HAP and water quality) and health status, while the other exploratory sub-study will assess the reactivity of participants to the use of remotely reporting electronic sensors to measure target behaviours.
Study:
NCT02239250
Study Brief:
Protocol Section:
NCT02239250