Evaluation of an Information Management and Communication System for Population-wide Point-of-Care Infant Sickle Cell Disease Screening (SMICS)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
We will conduct a cluster randomized trial (CRT) of the novel SCD SIMCS and utilize a logical framework of measurable indicators of barriers, utilization, mediating factors, and clinical outcomes of SCD screening and care to evaluate its impact. We will randomize health facilities rather than individual patients because it would be impossible to avoid contamination if we randomized individuals. This design is ideal for evaluating the effectiveness of systems level interventions.
Study procedures Trial Intervention. SCD SIMCS APP, which is an AI-enhanced mobile platform that captures, interprets and relays results of point of care tests for SCD to health care providers and to a centralised public data server at the Uganda Ministry of Health. The SCD SIMCS app prototype consists of four modules: (1) ID module - captures child's demographic and biometric data and builds a printable QR-code; (2) Assay module - captures HemoTypeSCTM and the Sickle Scan TM test image, interprets, and transmits results to the CPHL data centre; (3) Education module - stores and plays back short educational videos for pre- and post-screening counselling; (4) SCD e-Passport module - entry and display of child's longitudinal salient clinical information.
Baseline assessment; following stratified purposive sampling and consent from community leaders, Control and Experimental HCs will undergo baseline evaluation with regards to current resources and childcare visit workflows and the availability of the data sources and measurable indicators of interest. A baseline assessment of resources, workflows, and routine source data collection systems at the centres will facilitate implementation planning for the proposed SCD SIMCS and accurate measurement of its impact on the HCs.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mwanje Kavuma Mwanje
- Telefonnummer: +256783132151
- E-post: mwanjemobo@gmail.com
Studiesteder
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Jinja, Uganda
- Rekruttering
- Nalufenya Childrens
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Ta kontakt med:
- Emmanuel Tenywa
- Telefonnummer: 0703672573
- E-post: etenywa81@gmail.com
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Underetterforsker:
- Ruth Namazzi
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Hovedetterforsker:
- Nelson Sewankambo
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Providers of child health and maternity services at selected hospitals Infants born or attending child health and maternity services at selected hospitals . Infants are the targeted age-group in this study because this is the ideal age to screen for SCD and prevent complications and mortality that generally occurs early, by 5 years old. The infants will be recruited at birth or at vaccination visits
Exclusion Criteria:
- Decline of inability to provide informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Traditional centralised testing to point of care testing
Routine new born screening strategy in health care centres in Uganda
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Mobile Health information managment system
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Aktiv komparator: Information management and communication system
Mobile Information Managment system
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Mobile Health information managment system
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Improved number and timeliness of refferal of infants with sickle cell disease for care
Tidsramme: 12 months
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proportion with positive sickle cell disease screen recievign conformatory SCD test,penicillin , hydroxyurea
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12 months
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Ajusted Mortality Rate of children with sickle cell disease
Tidsramme: 18 months
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Evaluate the impact of the SCD SIMCS on access to screening.
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18 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Mak-SOMREC-2025-2124
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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