Diarrhoeal DiseaseNCT02239250
Water Filters and Improved Cookstoves in Western Rwanda
A study testing Water filter and cookstove in people with Diarrhoeal Disease and Respiratory Infection, run by London School of Hygiene and Tropical Medicine at 1 site in Rwanda.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Diarrhoeal Disease, Respiratory Infection, Pneumonia
- What is being tested?
- Water filter and cookstove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,582 participants
- Where
- 1 siteRwanda
- Study dates
- Aug 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For Sector-level study:
- All households shown on updated 2012 government registers to be members of ubudehe 1 and 2 in Western Province, Rwanda will be eligible to participate in the study.
- For nested village-level study:
- All villages from all sectors in Western province, according to official Government lists will be eligible for participation with the exception of those villages that were selected for participation in Phase 1.
- At the village-level, all households that are classified as ubudehe 1 \& 2 according to updated 2012 government registers, are part of the village, are able to provide informed consent, and that have at least one child under 4 years of age at the time of enrollment will be eligible for participation. Presence of a child under 4 years of age will be assessed by checking dates of birth or recorded age in months in the CHW register of children <5 years (Igitabo Cy'Ibikorwa Byo Gukurikirana), which are maintained at the village by CHW (though occasionally these are transferred to health centers). If this data is missing will be assesses based on CHW's report. In those cases where a village has more than the required number of participating households (10 household), a random selection of 10 households will be drawn.
- For the assessment of personal exposure to HAP a stricter set of eligibility criteria will be applied. Households that comply with the following eligibility criteria will be eligible for the exposure to HAP sub-study.
Show all 13Show fewer
- Have a child 1.5-4 year old,
- Have a child healthy enough to wear the monitoring equipment (as perceived by the mother),
- Have a non-smoking primary cook,
- Have a primary cook that is currently not pregnant (as far as she is aware of), and
- Have a primary cook that is in a healthy state to wear the monitoring equipment
- The first two households identified from a randomised list will be invited to participate.
- For the biomarker sub-studies, both the primary cook and the child under 4 years of age from households undergoing HAP exposure assessment will be eligible for the inflammatory cytokine biomarker study. For the enteric seroconversion study, all children aged 6 to 12 months will be eligible for participation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Health Impact of Advance Water Filters and Improved Cookstoves in Western Province, Rwanda: A Cluster-randomised Controlled Trial
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.
Read more
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.
- Conditions
- Diarrhoeal Disease, Respiratory Infection, Pneumonia
- Being tested
- Water filter and cookstove
- Keywords
- Child health, Pneumonia, Diarrhoea, Household air pollution, PM2.5, Stove intervention, Biomass fuel, Monitoring and evaluation, Water filter, Compliance, Thermotolerant coliforms, Rwanda
- Medical subject headings
- Respiratory Tract Infections, Pneumonia, Diarrhea, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water filter and cookstoveDevice
Also called Vestergaard Frandsen Lifestraw Family™ 2.1, EcoZoom™ Spartan
The Vestergaard Frandsen Lifestraw Family™ 2.1 is a point-of-use water treatment system.Water is poured through a 20 micron pre-filter into a 6L influent water tank.This water then filters through a 0.20 micron hollow-fiber ultrafiltration membrane into a 5.5L storage container.Water is then poured through a plastic tap, which prevents re-contamination.This system filters up to 18,000L of water.The system exceeds the WHO's "highly protective" standard for household water treatment technologies.The EcoZoom™ Spartan stove concentrates the combustion process while channeling airflow to completely burn the fuel provided.The stove has a ceramic combustion chamber within a steel housing, which is topped with a cast iron stove.The stove includes a rack for placing firewood and a pot skirt that improves the thermal efficiency.The cookstoves and filters will be delivered together at no cost to participating households.Households will receive instructions on how to operate these devices.
| Study group | Role | What they receive |
|---|---|---|
| Water filter and cookstove | Experimental | All household that appear on Government approved lists as belonging to ubudehe 1 \& 2 categories in the 72 sectors randomised as intervention sectors will be eligible to receive one free water filtering device and one free cookstove. All households will be given instructions of how to use the intervention. Receives: Device: Water filter and cookstove |
| Control | No intervention | All household that appear on Government approved lists as belonging to ubudehe 1 \& 2 categories in the 24 sectors randomised as control sectors will continue with their traditional cooking methods and drinking practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
All types of pneumonia (severe, non severe). This outcome measure will be assessed in the sector-level study.
Measured: 12 months
Incidence of IMCI defined diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
All types of diarrhoea (including severe, persistent, dysentery). This outcome measure will be assessed in the sector-level study.
Measured: 12 months
Secondary outcomes (4)
All-cause mortality in children under 5 years of age in ubudehe 1 & categories
This outcome measure will be assessed in the sector-level study.
Measured: 12 months
Incidence of maternal health outcomes among women un ubudehe 1 & 2 categories
Incidence of maternal health outcomes including low birth weight, premature birth, and still birth
Measured: 12 months
Prevalence of self-reported diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
This outcome measure will be assessed in the nested village-level study.
Measured: 12 months
Prevalence of pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
This outcome measure will be assessed in the nested village-level study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diarrhoeal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,582 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- DelAgua, Emory University, Portland State University, University of Colorado, Boulder, Oregon Health and Science University, Ministry of Health, Rwanda, National University, Rwanda
- Responsible party
- Sponsor
- Investigators
- Thomas Clasen, JD MSc PhD, Principal investigator, LSHTM & Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239250
- Sponsor's protocol ID
- NCT01882777_2
- Status last verified
- Feb 2015
- First submitted
- 9 Sep 2014
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirby MA, Nagel CL, Rosa G, Zambrano LD, Musafiri S, Ngirabega JD, Thomas EA, Clasen T. Effects of a large-scale distribution of water filters and natural draft rocket-style cookstoves on diarrhea and acute respiratory infection: A cluster-randomized controlled trial in Western Province, Rwanda. PLoS Med. 2019 Jun 3;16(6):e1002812. doi: 10.1371/journal.pmed.1002812. eCollection 2019 Jun.
PubMed 31158266Nagel CL, Kirby MA, Zambrano LD, Rosa G, Barstow CK, Thomas EA, Clasen TF. Study design of a cluster-randomized controlled trial to evaluate a large-scale distribution of cook stoves and water filters in Western Province, Rwanda. Contemp Clin Trials Commun. 2016 Aug 2;4:124-135. doi: 10.1016/j.conctc.2016.07.003. eCollection 2016 Dec 15.
PubMed 29736475
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Health Impact of Advance Water Filters and Improved Cookstoves in Western Province, Rwanda: A Cluster-randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02239250
- Acronym / sponsor ID
- NCT01882777_2
- Conditions
- Diarrhoeal Disease, Respiratory Infection, Pneumonia
- Keywords
- Child health, Pneumonia, Diarrhoea, Household air pollution, PM2.5, Stove intervention, Biomass fuel, Monitoring and evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,582 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- DelAgua, Emory University, Portland State University, University of Colorado, Boulder, Oregon Health and Science University, Ministry of Health, Rwanda, National University, Rwanda
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water filter and cookstove | Experimental | Device: Water filter and cookstoveAll household that appear on Government approved lists as belonging to ubudehe 1 \& 2 categories in the 72 sectors randomised as intervention sectors will be eligible to receive one free water filtering device and one free cookstove. All households will be given instructions of how to use the intervention. |
| Control | No intervention | –All household that appear on Government approved lists as belonging to ubudehe 1 \& 2 categories in the 24 sectors randomised as control sectors will continue with their traditional cooking methods and drinking practices. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- For Sector-level study:
- All households shown on updated 2012 government registers to be members of ubudehe 1 and 2 in Western Province, Rwanda will be eligible to participate in the study.
- For nested village-level study:
- All villages from all sectors in Western province, according to official Government lists will be eligible for participation with the exception of those villages that were selected for participation in Phase 1.
- At the village-level, all households that are classified as ubudehe 1 \& 2 according to updated 2012 government registers, are part of the village, are able to provide informed consent, and that have at least one child under 4 years of age at the time of enrollment will be eligible for participation. Presence of a child under 4 years of age will be assessed by checking dates of birth or recorded age in months in the CHW register of children <5 years (Igitabo Cy'Ibikorwa Byo Gukurikirana), which are maintained at the village by CHW (though occasionally these are transferred to health centers). If this data is missing will be assesses based on CHW's report. In those cases where a village has more than the required number of participating households (10 household), a random selection of 10 households will be drawn.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water filter and cookstoveAlso: Vestergaard Frandsen Lifestraw Family™ 2.1, EcoZoom™ SpartanThe Vestergaard Frandsen Lifestraw Family™ 2.1 is a point-of-use water treatment system.Water is poured through a 20 micron pre-filter into a 6L influent water tank.This water then filters through a 0.20 micron hollow-fiber ultrafiltration membrane into a 5.5L storage container.Water is then poured through a plastic tap, which prevents re-contamination.This system filters up to 18,000L of water.The system exceeds the WHO's "highly protective" standard for household water treatment technologies.The EcoZoom™ Spartan stove concentrates the combustion process while channeling airflow to completely burn the fuel provided.The stove has a ceramic combustion chamber within a steel housing, which is topped with a cast iron stove.The stove includes a rack for placing firewood and a pot skirt that improves the thermal efficiency.The cookstoves and filters will be delivered together at no cost to participating households.Households will receive instructions on how to operate these devices. | Device | Water filter and cookstove |
Primary outcome
Incidence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
Time frame: 12 months
All types of pneumonia (severe, non severe). This outcome measure will be assessed in the sector-level study.
Incidence of IMCI defined diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
Time frame: 12 months
All types of diarrhoea (including severe, persistent, dysentery). This outcome measure will be assessed in the sector-level study.
4 secondary outcomes
All-cause mortality in children under 5 years of age in ubudehe 1 & categories
Time frame: 12 months
Incidence of maternal health outcomes among women un ubudehe 1 & 2 categories
Time frame: 12 months
Prevalence of self-reported diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
Time frame: 12 months
Prevalence of pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Derived from this study: PubMed 31158266Kirby MA, Nagel CL, Rosa G, Zambrano LD, Musafiri S, Ngirabega JD, Thomas EA, Clasen T. Effects of a large-scale distribution of water filters and natural draft rocket-style cookstoves on diarrhea and acute respiratory infection: A cluster-randomized controlled trial in Western Province, Rwanda. PLoS Med. 2019 Jun 3;16(6):e1002812. doi: 10.1371/journal.pmed.1002812. eCollection 2019 Jun.
- Derived from this study: PubMed 29736475Nagel CL, Kirby MA, Zambrano LD, Rosa G, Barstow CK, Thomas EA, Clasen TF. Study design of a cluster-randomized controlled trial to evaluate a large-scale distribution of cook stoves and water filters in Western Province, Rwanda. Contemp Clin Trials Commun. 2016 Aug 2;4:124-135. doi: 10.1016/j.conctc.2016.07.003. eCollection 2016 Dec 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Clasen, JD MSc PhD principal investigator
LSHTM & Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water filter and cookstove in people with Diarrhoeal Disease and Respiratory Infection, run by London School of Hygiene and Tropical Medicine at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02239250, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.