EFFECTIVENESS OF A SCHOOL-CENTRED PRIMARY AND SECONDARY PREVENTION PROGRAM ON PREVALENCE OF LATENT RHEUMATIC HEART DISEASE (PREVENT RHD)
This study consists in an RHD awareness campaign and a school nurse program providing integrated health care through assessment, intervention, and follow-up of GABHS pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with latent RHD.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This study is conducted an incomplete stepped wedge cluster randomized trial in three countries with an endemic pattern of RHD. Individual schools are considered clusters and will be randomly selected from a pool of schools in Kathmandu (Nepal), Lusaka (Zambia), and Mekelle (Ethiopia). The clusters will be randomized to their position stratified by country so that each country has the same number of schools in the different phases. There will be three steps and the length of each step will be one year. Every cluster will provide before and after observations and every cluster will switch from a control phase to an experimental phase according to their randomization result. The experimental phase consists of a school-nurse program accompanied by an awareness program and will be delivered at the level of the cluster. The most important reason to use a stepped wedge rather than a parallel group cluster randomized design is that all included children attending participating schools will eventually benefit from the school-based prevention program.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Guy Kayeye Muula, MD, MPH
- Telefonnummer: 0971747550
- E-post: Guy.Muula@cidrz.org
Studiesteder
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Lusaka Province
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Lusaka, Lusaka Province, Zambia, 10101
- Rekruttering
- Kalingalinga
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
20000
Beskrivelse
Inclusion Criteria:
- Age 5-16 years
- Attending a randomly selected school at one of the three study sites
Exclusion Criteria:
- Children / primary caregivers not providing informed consent to participate.
- Children not attending one of the selected schools
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: CROSS_SECTIONAL
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the effectiveness of an integrated, school-based program for the prevention of RHD in regions with an endemic pattern of RHD.
Tidsramme: Incidence of newly diagnosed definite or probable rheumatic heart disease during the follow-up period.
|
The primary measures is to acertain the Incidence of definite or probable RHD among participating school-aged children during the study follow-up period. Incidence of new echocardiographically detected RHD among children who were free of RHD at baseline. Incidence of RHD per 1,000 person-years, comparing children in the intervention group with those in the control/usual-care group. The incidence of newly diagnosed definite or probable RHD among participants who do not have definite or probable RHD at baseline. RHD status will be determined using echocardiographic assessment according to the study-defined diagnostic criteria. The outcome will be reported as the number and percentage of participants developing new RHD in each study group during the 24-month follow-up period. |
Incidence of newly diagnosed definite or probable rheumatic heart disease during the follow-up period.
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Prevent RHD 5848-2024
Legemiddel- og utstyrsinformasjon, studiedokumenter
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