Rheumatic Heart DiseaseNEARER SCANNCT06002243
Non-Expert Acquisition & Remote Expert Review of Screening Echocardiography Images From Child Health & AnteNatal Clinics
A study testing SPLASH echocardiography screening in people with Rheumatic Heart Disease, run by Menzies School of Health Research.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- SPLASH echocardiography screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Non-Expert Acquisition and Remote Expert Review of Screening Echocardiography Images From Child Health and AnteNatal Clinics (NEARER SCAN)
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.
Read the detailed description
This study titled 'Non-Expert Acquisition and Remote Expert Review of Screening echocardiography images from Child health and AnteNatal clinics' (NEARER SCAN; "LENO BESIK" in Tetum) aims to co-design, implement and evaluate a task-sharing approach to echocardiographic screening for early detection and management of rheumatic heart disease (RHD) in high-risk settings in Australia and Timor-Leste.
Specific objectives include:
- To co-design implementation strategies with communities underpinned by local program theories.
- To implement SPLASH echocardiography training and a task-sharing approach to echocardiographic screening for early detection and management of RHD in communities, based on co-designed implementation strategies.
- To conduct a realist evaluation to understand what implementation strategies assist in integrating this intervention into routine health service delivery and why.
- To determine the clinical effectiveness of the intervention in terms of impact on key clinical outcome measures.
- To conduct cost-of-illness, cost-effectiveness and budget-impact analyses of the task-sharing approach to echocardiographic screening for early detection and management of RHD in Australia and Timor-Leste.
Local primary health clinic staff will be trained to perform focused echocardiography using hand-carried ultrasound (HCU) devices employing the 'Single Parasternal Long Axis view with a Sweep of the Heart' (SPLASH) technique. The acquired images will be interpreted by experts (cardiologists and cardiac sonographers) remotely from the site of acquisition. Approximately 1500 children and pregnant women will be screened across high-risk communities in Australia and Timor Leste, over an 18 month period.
A mixed-methods effectiveness-implementation study design will be used to evaluate the implementation of an intervention designed to achieve early detection and management of RHD in high-risk populations. An implementation strategy will be co-designed at each site with the local community and participating primary healthcare (PHC) service, incorporating non-adaptable elements of the intervention, and mapped onto a Theory of Change framework. Co-design, implementation and evaluation will occur simultaneously, and a Type 2 hybrid design study will be used to evaluate both the implementation strategies and the clinical effectiveness of the intervention. The clinical effectiveness will be assessed as the change in the proportion of the at-risk population that received secondary prophylaxis by the end of the study compared to baseline. Program implementation will be evaluated with a realist evaluation to explain under what circumstances the program is successfully integrated into routine service delivery. Data informing evaluation will include numbers of normal, abnormal, and uninterpretable SPLASH echocardiograms obtained, numbers of participants progressing through the cascade of care, augmented by qualitative data from interviews conducted with staff and participants, and costs.
- Conditions
- Rheumatic Heart Disease
- Being tested
- SPLASH echocardiography screening
- Keywords
- Echocardiography, Task-sharing, Aboriginal and Torres Strait Islander Peoples, Pregnancy, Children, First Nation Peoples
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPLASH echocardiography screeningDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participant receiving echocardiography screening. Receives: Diagnostic Test: SPLASH echocardiography screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months from commencement of study
Secondary outcomes (7)
Full echocardiogram following screening echocardiogram
Proportion of people with an abnormal or uninterpretable screening echocardiogram who get a full diagnostic echocardiogram within 3 months and receive a diagnosis.
Measured: 3 months from screening echocardiogram
Proportion of people diagnosed with RHD who are retained in care
Proportion of people diagnosed during study period with RHD who receive guideline-based care by local health service
Measured: 18 months from commencement of study
Secondary antibiotic prophylaxis prescription and adherence
Proportion of people prescribed secondary prophylaxis who are achieving >= 80% adherence in a 12 months period from time of diagnosis or the end of the study, whichever is longer.
Measured: 12 months from time of diagnosis or at end of the study (which ever is longer).
Maternal morbidity and mortality outcomes
Description of maternal morbidity and mortality in pregnant women diagnosed with RHD on echocardiographic screening. This will be reported in absolute numbers and percentage of study population. Morbidity will include cardiac complications (heart failure, arrhythmia, aborted sudden cardiac death, acute myocardial infarction), need for obstetric intervention including emergency cesarean section, intensive care admission, other obstetric complications.
Measured: Within 6 weeks of the individual's post-partum period
Prevalence of rheumatic heart disease within the screened population
Prevalence of RHD in screened population based on echocardiographic diagnosis
Measured: 18 months from commencement of study
Rheumatic valvular heart disease severity (mild, moderate or severe) within the screening population based on echocardiographic diagnosis
Description of severity of RHD in screened population. This will include proportions of mild, moderate and severe valve disease.
Measured: 18 months from commencement of study
Neonatal morbidity and mortality outcomes
Description of neonatal morbidity and mortality outcomes for the pregnant women diagnosed with RHD. This will be reported as absolute numbers and percentage of study population. Morbidity will include need for admission to neonatal intensive care.
Measured: Within 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startApr 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Western Australia, Telethon Kids Institute, Western Australian Country Health Service, Northern Territory Government of Australia, Timor-Leste Ministry of Health, Miwatj Health Aboriginal Corporation, Mala'la Health Service Aboriginal Corporation, Pilbara Aboriginal Health Alliance
- Responsible party
- Principal investigator, Joshua Francis, Menzies School of Health Research
- Investigators
- Joshua R Francis, MBBS, Principal investigator, Menzies School of Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002243
- Sponsor's protocol ID
- APP2015869
- Acronym
- NEARER SCAN
- Status last verified
- Mar 2024
- First submitted
- 13 Jun 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39424380
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Expert Acquisition and Remote Expert Review of Screening Echocardiography Images From Child Health and AnteNatal Clinics (NEARER SCAN)
- ClinicalTrials.gov ID
- NCT06002243
- Acronym / sponsor ID
- NEARER SCAN / APP2015869
- Conditions
- Rheumatic Heart Disease
- Keywords
- Echocardiography, Task-sharing, Aboriginal and Torres Strait Islander Peoples, Pregnancy, Children, First Nation Peoples
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- The University of Western Australia, Telethon Kids Institute, Western Australian Country Health Service, Northern Territory Government of Australia, Timor-Leste Ministry of Health, Miwatj Health Aboriginal Corporation, Mala'la Health Service Aboriginal Corporation, Pilbara Aboriginal Health Alliance
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study titled 'Non-Expert Acquisition and Remote Expert Review of Screening echocardiography images from Child health and AnteNatal clinics' (NEARER SCAN; "LENO BESIK" in Tetum) aims to co-design, implement and evaluate a task-sharing approach to echocardiographic screening for early detection and management of rheumatic heart disease (RHD) in high-risk settings in Australia and Timor-Leste.
Specific objectives include:
- To co-design implementation strategies with communities underpinned by local program theories.
- To implement SPLASH echocardiography training and a task-sharing approach to echocardiographic screening for early detection and management of RHD in communities, based on co-designed implementation strategies.
- To conduct a realist evaluation to understand what implementation strategies assist in integrating this intervention into routine health service delivery and why.
- To determine the clinical effectiveness of the intervention in terms of impact on key clinical outcome measures.
- To conduct cost-of-illness, cost-effectiveness and budget-impact analyses of the task-sharing approach to echocardiographic screening for early detection and management of RHD in Australia and Timor-Leste.
Local primary health clinic staff will be trained to perform focused echocardiography using hand-carried ultrasound (HCU) devices employing the 'Single Parasternal Long Axis view with a Sweep of the Heart' (SPLASH) technique. The acquired images will be interpreted by experts (cardiologists and cardiac sonographers) remotely from the site of acquisition. Approximately 1500 children and pregnant women will be screened across high-risk communities in Australia and Timor Leste, over an 18 month period.
A mixed-methods effectiveness-implementation study design will be used to evaluate the implementation of an intervention designed to achieve early detection and management of RHD in high-risk populations. An implementation strategy will be co-designed at each site with the local community and participating primary healthcare (PHC) service, incorporating non-adaptable elements of the intervention, and mapped onto a Theory of Change framework. Co-design, implementation and evaluation will occur simultaneously, and a Type 2 hybrid design study will be used to evaluate both the implementation strategies and the clinical effectiveness of the intervention. The clinical effectiveness will be assessed as the change in the proportion of the at-risk population that received secondary prophylaxis by the end of the study compared to baseline. Program implementation will be evaluated with a realist evaluation to explain under what circumstances the program is successfully integrated into routine service delivery. Data informing evaluation will include numbers of normal, abnormal, and uninterpretable SPLASH echocardiograms obtained, numbers of participants progressing through the cascade of care, augmented by qualitative data from interviews conducted with staff and participants, and costs.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: SPLASH echocardiography screeningParticipant receiving echocardiography screening. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPLASH echocardiography screeningScreening 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. | Diagnostic test | Intervention |
Primary outcome
Change in proportion receiving secondary antibiotic prophylaxis
Time frame: 18 months from commencement of study
The change in proportion of the at-risk population receiving secondary antibiotic prophylaxis at the end of the study as compared to baseline
7 secondary outcomes
Full echocardiogram following screening echocardiogram
Time frame: 3 months from screening echocardiogram
Proportion of people diagnosed with RHD who are retained in care
Time frame: 18 months from commencement of study
Secondary antibiotic prophylaxis prescription and adherence
Time frame: 12 months from time of diagnosis or at end of the study (which ever is longer).
Maternal morbidity and mortality outcomes
Time frame: Within 6 weeks of the individual's post-partum period
Prevalence of rheumatic heart disease within the screened population
Time frame: 18 months from commencement of study
Rheumatic valvular heart disease severity (mild, moderate or severe) within the screening population based on echocardiographic diagnosis
Time frame: 18 months from commencement of study
Neonatal morbidity and mortality outcomes
Time frame: Within 6 weeks post-partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 39424380Jones 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.
- Individual participant dataSharing planned: No
Related trials for Rheumatic Heart Disease
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Not yet recruiting
Assessment of the Prevalence of Rheumatic Heart Disease in School Settings in Mayotte and the Acquisition of Ultrasound Sequences Guided by Artificial Intelligence
Rheumatic Heart Diseases, Scabies
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruitingPhase 2
GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial
Rheumatic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua R Francis, MBBS principal investigator
Menzies School of Health Research
Questions about this trial
What is this clinical trial studying?
A study testing SPLASH echocardiography screening in people with Rheumatic Heart Disease, run by Menzies School of Health Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua R Francis, MBBS (+61423528381, josh.francis@menzies.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proportion receiving secondary antibiotic prophylaxis (time frame: 18 months from commencement of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.