- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03972618
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Santo Domingo, Dominikanske republik
- Child Hope Network
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Lives in selected villages and has children that attend the local school
Exclusion Criteria:
- No children attending the local school
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: School and village
Simultaneous installation of filters in schools and the village
|
Installation of water filtration system and education on hand washing.
|
|
Eksperimentel: School only
Initial installation in school only
|
Installation of water filtration system and education on hand washing.
|
|
Eksperimentel: Village only
Initial installation in village only
|
Installation of water filtration system and education on hand washing.
|
|
Ingen indgriben: Control
Control group.
No filter installation initially.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diarrhea
Tidsramme: 2-weeks
|
self-report of diarrhea
|
2-weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nathan Tintle, Ph.D., Dordt College
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DR001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Diarré
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Merck Sharp & Dohme LLCAfsluttetClostridium Difficile Associated Diarrhea (CDAD)
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Merck Sharp & Dohme LLCAfsluttetClostridium Difficile Associated Diarrhea (CDAD)
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PharmaPlanter Technologies IncIkke rekrutterer endnuIrritabel tyktarm (IBS) | Clostridioides Difficile-infektion | Irritable Towel Syndrome, Diarrhea-Predominant (IBS-D) | Gentagne Clostridioides difficile infektion (RCDI) | Fækal mikrobiota -terapi (FMT)