Non-Expert Acquisition & Remote Expert Review of Screening Echocardiography Images From Child Health & AnteNatal Clinics

NCT06002243 | Not Yet Recruiting DMC

• 1 other identifier: APP2015869
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Non-Expert Acquisition and Remote Expert Review of Screening echocardiography images from Child health and AnteNatal clinics (NEARER SCAN) study is a co-designed, implementation research project that will improve equitable access to culturally safe, best quality care for Rheumatic Heart Disease (RHD) in high-burden Aboriginal and Torres Strait Islander communities in Australia, and in Timor-Leste. The research addresses an area of unmet need, using novel technologies and embedding them in health practice, to enhance and accelerate diagnosis of RHD outside acute health settings and improve outcomes. The study will be conducted in partnership with community leaders and local partners.

Conditions

Rheumatic Heart Disease

Keywords

Echocardiography; Task-sharing; Aboriginal and Torres Strait Islander Peoples; Pregnancy; Children; First Nation Peoples

Outcome Measures

Primary Outcomes (1)

• Change in proportion receiving secondary antibiotic prophylaxis

  The change in proportion of the at-risk population receiving secondary antibiotic prophylaxis at the end of the study as compared to baseline

  18 months from commencement of study

Secondary Outcomes (7)

• Full echocardiogram following screening echocardiogram

  3 months from screening echocardiogram

• Proportion of people diagnosed with RHD who are retained in care

  18 months from commencement of study

• Secondary antibiotic prophylaxis prescription and adherence

  12 months from time of diagnosis or at end of the study (which ever is longer).

• Maternal morbidity and mortality outcomes

  Within 6 weeks of the individual's post-partum period

• Prevalence of rheumatic heart disease within the screened population

  18 months from commencement of study

Study Arms (1)

Intervention

EXPERIMENTAL

Participant receiving echocardiography screening.

Diagnostic Test: SPLASH echocardiography screening

Interventions

SPLASH echocardiography screening DIAGNOSTIC_TEST

Screening echocardiogram performed by a briefly trained health worker with images reviewed off site by an expert cardiologist or cardiac sonographer to determine screening outcome. Screening outcome may include: screen positive, screen negative or uninterpretable images.

Intervention

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any child between the age of 5 - 20 years old living in the participating community
• Pregnant women at high risk for RHD undergoing antenatal appointments or a hospital admission will be invited to participate. High risk for RHD will be defined as being from an area where RHD all-age prevalence is \>1/1000 RHD or acute rheumatic fever incidence \>30/100,000 per year in 5-14-year-olds. For practical purposes, this means Aboriginal women living in urban, rural or remote communities in northern Australia, or immigrants from high-risk settings.
• Any child between the age of 5-20 years old and any pregnant woman.

You may not qualify if:

• Women who are unable to consent due to physical, mental, or intellectual disability will be excluded. Women and children with known existing cardiac disease will NOT be excluded since evaluation of severity and change in severity during pregnancy will be tracked, and data will inform the calculation of prevalence.

Sponsors & Collaborators

• Menzies School of Health Research: lead
• The University of Western Australia: collaborator
• Telethon Kids Institute: collaborator
• Western Australian Country Health Service: collaborator
• Northern Territory Government of Australia: collaborator
• Timor-Leste Ministry of Health: collaborator
• Miwatj Health Aboriginal Corporation: collaborator
• Mala'la Health Service Aboriginal Corporation: collaborator
• Pilbara Aboriginal Health Alliance: collaborator

Related Publications (1)

• Jones B, Marangou J, Yan J, Ralph A, Mitchell A, Kaethner A, Remenyi B, Wade V, Katzenellenbogen JM, Monteiro AF, Cannon JW, Howard NJ, Gilles M, Haynes E, Seixas H, Maurays J, Neave J, Pears C, Engelman D, Canuto K, Steer A, Unger H, Bailey M, Tanesi M, Amaral S, Neto H, Stewart M, Burgess P, Brown A, Currie BJ, Hillis G, Morris P, Simon D, Wheaton G, Williamson J, de Dassel J, Slota-Kan S, Carapetis J, English M, Nagraj S, Francis JR. NEARER SCAN (LENO BESIK) evaluation of a task-sharing echocardiographic active case finding programme for rheumatic heart disease in Australia and Timor-Leste: protocol for a hybrid type II effectiveness-implementation study. BMJ Open. 2024 Oct 18;14(10):e083467. doi: 10.1136/bmjopen-2023-083467.

  PMID: 39424380 DERIVED

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Study Officials

• Joshua R Francis, MBBS

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua R Francis, MBBS

CONTACT

+61423528381; josh.francis@menzies.edu.au

James A Marangou, MBBS

CONTACT

+61412277527; james.marangou@menzies.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: August 21, 2023
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share