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Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda (SHIELD 2)

19. maj 2026 opdateret af: Children's Hospital Medical Center, Cincinnati

Developing and Testing a Registry-Enabled Strategy (ACT+) to Reduce Loss to Follow-Up Between Screening and Confirmation of Rheumatic Heart Disease in Uganda

This study aims to improve follow-up care after positive rheumatic heart disease (RHD) screening in Northern Uganda. It will identify barriers and co-develop an enhanced ACT+ strategy, then evaluate its effectiveness in increasing linkage to confirmatory echocardiography, along with its adoption, acceptability, and feasibility. Secondary outcomes include time to diagnosis, initiation of treatment, and factors influencing implementation.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Uganda
      • Kampala, Uganda
        • Uganda Heart Institute
        • Kontakt:
        • Ledende efterforsker:
          • Jafes Pulles

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria: Community Members

  • 18 years of age or older
  • Received a positive ADUNU echocardiographic screening result within the past 24 months OR parent/legal guardian of a minor who received a positive ADUNU echocardiographic screening result within the past 24 months

Inclusion Criteria: Providers

  • Employed at an ADUNU-participating facility or confirmatory echo facilities at the time of study
  • Holds a designated ADUNU role (nurse screener, confirmatory provider, or referral support staff) or is involved in RHD screening, diagnosis or care
  • Ability to provide informed consent in Acholi, Luo, or English

Inclusion Criteria: Regional RHT ACT Nurse Coordinator

  • Employed as a Regional ACT Nurse at the time of study
  • Has familiarity with ADUNU program
  • Ability to provide informed consent in Acholi, Luo, or English

Inclusion Criteria: District Health Office Team Members and District RHD Focal Persons

  • Employed at District Health Office within an ADUNU-participating district
  • Has familiarity with ADUNU program
  • Ability to provide informed consent in Acholi, Luo, or English

Exclusion Criteria:

  • No formal exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Inspiration/Discovery (1A)
Semi-structured qualitative interviews with screen-positive community members (or parents/guardians of community members) and ADUNU providers to characterize multilevel barriers and facilitators.
Ingen indgriben: Ideation/Design (1B)
A structured participatory design workshop with a 15-member HCD expert panel, followed by iterative co-design sessions to produce finalized ACT+ features and workflows.
Aktiv komparator: Healthcare Facilities will receive ACT+ Intervention

The ACT+ strategy consists of three coordinated, registry-enabled implementation components co-designed and refined through the Aim 1 HCD process.

Component 1: Digitized Pre-Confirmation Registry Entry and Patient Tracking ACT+ will enable entry of screen-positive individuals into the ACT registry at the time of positive screen (prior to confirmatory diagnosis).

Component 2: Patient Tracing and Reminder System ACT+ will support automated and semi-automated outreach to screen-positive who have not yet completed confirmatory echocardiography.

Component 3: Audit and Feedback for Providers and Facilities ACT+ dashboards will provide facility-level, real-time feedback on LTFU rates, confirmation completion, and the screening-to-SAP initiation cascade.
Andet: The ACT+ Strategy
The Active Community Case Management Tool (ACT) is a cloud-based, dynamic RHD case management tool developed by CCHMC in partnership with global stakeholders, including UHI and the RRCU. ACT provides real-time data on patient status, clinical outcomes, and care processes, supporting both individual patient management (electronic medical record functions) and system-level quality improvement (registry and dashboard functions).
Ingen indgriben: Control: Standard of Care
Facilities in the control arm will continue current standard ADUNU practice: screen-positive individuals receive verbal and written referral information to one of three confirmatory sites immediately following screening.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Facility-level linkage to confirmation rate
Tidsramme: 9 months
The proportion of individuals with a positive ADUNU screening result who complete confirmatory echocardiography within the 9-month intervention period.
9 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time (days) from positive screen to confirmatory echocardiography
Tidsramme: 9 months
% providers entering >90% of screening records OR completing all monthly outreach activities
9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Hospital Medical Center, Cincinnati

Samarbejdspartnere

Uganda Heart Institute

Efterforskere

  • Ledende efterforsker: Andrea Beaton, Children's Hospital Medical Center, Cincinnati

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-0306

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Reumatisk hjertesygdom

Kliniske forsøg med The ACT+ Strategy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Congo, DR of

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner