DiarrheaNCT03972618
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
A study testing Installation of water filtration system for filtering existing water source in people with Diarrhea, run by Dordt University at 1 site in Dominican Republic.
Trial summary
Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Installation of water filtration system for filtering existing water source
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 1 siteDominican Republic
- Study dates
- 22 Sep 2018to 15 Apr 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lives in selected villages and has children that attend the local school
Who cannot join
- No children attending the local school
Trial locations and contacts
1 site in 1 country.
About this study
Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms including schools, homes, simultaneous home/school and a control group
Read the detailed description
Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College and Sawyer Products, Inc. to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms:
Arm 1: Simultaneous installation of filters in schools and the villages sending children to the school Arm 2: Initial installation of the water filters in a school, with later installation in the corresponding village Arm 3: Instillation of the water filters in villages, with later installation in the corresponding school Arm 4: Control arm. No filter installation initially but, ultimately, installation of filters in both the schools and villages.
Self-reported information on filter usage and health outcomes will be collected through surveys administered to parents (in the households in the villages), teachers (in the schools) and school administrators. Data collection will occur at baseline (when filters are installed), at 2 and 8 weeks post installation. The major goal of this project is to better understand the different health impacts of each different deployment strategy on child and family wellbeing. Better understanding of these filter installation strategies will help guide us as we make filter deployment decisions to provide access to clean drinking water.
- Conditions
- Diarrhea
- Being tested
- Installation of water filtration system for filtering existing water source
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Installation of water filtration system for filtering existing water sourceBehavioural
Installation of water filtration system and education on hand washing.
| Study group | Role | What they receive |
|---|---|---|
| School and village | Experimental | Simultaneous installation of filters in schools and the village Receives: Behavioral: Installation of water filtration system for filtering existing water source |
| School only | Experimental | Initial installation in school only Receives: Behavioral: Installation of water filtration system for filtering existing water source |
| Village only | Experimental | Initial installation in village only Receives: Behavioral: Installation of water filtration system for filtering existing water source |
| Control | No intervention | Control group. No filter installation initially. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea
self-report of diarrhea
Measured: 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start22 Sep 2018
- Primary completion1 Mar 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dordt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Tintle, Ph.D., Principal investigator, Dordt College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972618
- Sponsor's protocol ID
- DR001
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable request
Publications
Tintle N, Van De Griend K, Ulrich R, Wade RD, Baar TM, Boven E, Cooper CEA, Couch O, Eekhoff L, Fry B, Goszkowicz GK, Hecksel MA, Heynen A, Laughlin JA, Les SM, Lombard TR, Munson BD, Peterson JM, Schumann E, Settecerri DJ, Spry JE, Summerfield MJ, Sunder M, Wade DR, Zonnefeld CG, Brokus SA, Moen FS, Slater AD, Peterson JW, Pikaart MJ, Krueger BP, Best AA. Diarrhea prevalence in a randomized, controlled prospective trial of point-of-use water filters in homes and schools in the Dominican Republic. Trop Med Health. 2021 Jan 4;49(1):1. doi: 10.1186/s41182-020-00291-y.
PubMed 33397511
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
- ClinicalTrials.gov ID
- NCT03972618
- Acronym / sponsor ID
- DR001
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Dordt UniversityUniversity, hospital or other
- Study start
- 22 Sep 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 3 Jun 2019 (actual)
- 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.
Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms including schools, homes, simultaneous home/school and a control group
Detailed description
Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College and Sawyer Products, Inc. to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms:
Arm 1: Simultaneous installation of filters in schools and the villages sending children to the school Arm 2: Initial installation of the water filters in a school, with later installation in the corresponding village Arm 3: Instillation of the water filters in villages, with later installation in the corresponding school Arm 4: Control arm. No filter installation initially but, ultimately, installation of filters in both the schools and villages.
Self-reported information on filter usage and health outcomes will be collected through surveys administered to parents (in the households in the villages), teachers (in the schools) and school administrators. Data collection will occur at baseline (when filters are installed), at 2 and 8 weeks post installation. The major goal of this project is to better understand the different health impacts of each different deployment strategy on child and family wellbeing. Better understanding of these filter installation strategies will help guide us as we make filter deployment decisions to provide access to clean drinking water.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| School and village | Experimental | Behavioral: Installation of water filtration system for filtering existing water sourceSimultaneous installation of filters in schools and the village |
| School only | Experimental | Behavioral: Installation of water filtration system for filtering existing water sourceInitial installation in school only |
| Village only | Experimental | Behavioral: Installation of water filtration system for filtering existing water sourceInitial installation in village only |
| Control | No intervention | –Control group. No filter installation initially. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lives in selected villages and has children that attend the local school
Key exclusion criteria (1 listed)
- No children attending the local school
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 |
|---|---|---|
| Installation of water filtration system for filtering existing water sourceInstallation of water filtration system and education on hand washing. | Behavioural | School and village, School only, Village only |
Primary outcome
Diarrhea
Time frame: 2-weeks
self-report of diarrhea
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 3 Jun 2019.
- Derived from this study: PubMed 33397511Tintle N, Van De Griend K, Ulrich R, Wade RD, Baar TM, Boven E, Cooper CEA, Couch O, Eekhoff L, Fry B, Goszkowicz GK, Hecksel MA, Heynen A, Laughlin JA, Les SM, Lombard TR, Munson BD, Peterson JM, Schumann E, Settecerri DJ, Spry JE, Summerfield MJ, Sunder M, Wade DR, Zonnefeld CG, Brokus SA, Moen FS, Slater AD, Peterson JW, Pikaart MJ, Krueger BP, Best AA. Diarrhea prevalence in a randomized, controlled prospective trial of point-of-use water filters in homes and schools in the Dominican Republic. Trop Med Health. 2021 Jan 4;49(1):1. doi: 10.1186/s41182-020-00291-y.
- Individual participant dataSharing planned: Undecided. Available upon reasonable request
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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.
Nathan Tintle, Ph.D. principal investigator
Dordt College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Installation of water filtration system for filtering existing water source in people with Diarrhea, run by Dordt University at 1 site in Dominican Republic.
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 1 inclusion and 1 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 3 Jun 2019. 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 Dominican Republic. 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?
Diarrhea (time frame: 2-weeks). 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 NCT03972618, which also lists 1 linked publication.
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 3 Jun 2019.