Rheumatic Heart DiseaseADD-RHD 2BNCT05668611
Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System
A study testing Primary Training Phase, Primary Assessment Phase and Primary Screening Phase in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial summary
The first primary objective of this study is to determine the diagnostic performance (sensitivity and specificity) of primary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers to accurately identify patients who are screen positive and screen… Read more about this study
- Who is it for?
- Ages 5 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- Primary Training Phase, Primary Assessment Phase and Primary Screening Phase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,628 participants
- Where
- 1 siteUganda
- Study dates
- 3 Jan 2023to 20 Dec 2023
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Attend same HCIII/IV sites that the MOH nurses work at
- Agree to participate via the study's informed consent
Who cannot join
- Very sick participants requiring transfer to higher level facility or inpatient care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design and Evaluation of a Train the Trainer Curriculum to Scale Up Automated Intelligence Supported Echocardiography for Rheumatic Heart Disease Screening in a Public Health Care System
The first primary objective of this study is to determine the diagnostic performance (sensitivity and specificity) of primary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease. The second primary objective is to determine the diagnostic performance (sensitivity and specificity) of secondary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by MOH nurse trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease.
Read the detailed description
Objective 1:
4 ultrasound naïve nurses (Primary) employed at the HCIII/IVs participating in ADD-RHD Part 1 (SOMREC REF 2021-61) in Lira, will be trained and certified by experts in echocardiography for RHD on focused RHD echocardiographic screening examination and interpretation using a novel AI guided software.
Focused RHD screening echocardiograms by the 4 nurses will be integrated into routine clinical practice at their assigned HCIII/IVs for 1 month.
Screen positive patients will be referred to LRRH for confirmatory echocardiogram using a Standard echocardiographic machine under the National RHD registry (SOMREC REF 2014-137).
All echocardiograms will be uploaded to a secure cloud-based server and over-read by a cardiologist with in one - two (1 - 2) weeks to ensure patient safety and to determine trainee performance.
Diagnostic accuracy, sensitivity, specificity, positive and negative predictive values will be calculated.
4 MOH trainees will use pre-recorded PowerPoint presentations to conduct hands-on training for phase 2 (secondary) nurses.
Objective 2:
Similar to Phase 1 with just a few exceptions. 12 MOH nurses will be trained and certified by MOH nurse trainers from phase 1 to acquire and interpret RHD focused screening echocardiograms using a novel AI guided software.
Screening will be integrated into routine care for 2 months and diagnostic performance assessed.
- Conditions
- Rheumatic Heart Disease
- Being tested
- Primary Training Phase, Primary Assessment Phase, Primary Screening Phase, Secondary Training Phase, Secondary Assessment Phase
- 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.
Primary Training PhaseOther
A four-day training program taken over the course of two weekends will include materials on RHD and RHD echocardiographic screening using focused artificial intelligence navigational guided echocardiographic acquisition to identify patients who are screen positive or screen negative for RHD. The echo protocol will be limited to the parasternal long axis-view (2D and color Doppler) focusing on mitral and aortic valve morphology and function and a single 2D apical 4 chamber view for auto EF. The curriculum package will include online modules, instructor delivered PowerPoint presentations, and hands on practice on volunteers with and without RHD.
Primary Assessment PhaseOther
A pre- and post-training test on RHD knowledge and diagnosis will be administered. A rapid competency assessment, including obtaining imaging on volunteers with or without RHD and an online test with pre-recorded cases of RHD, LV dysfunction and Pericardial effusions, will be utilized at the end of the 4-day training sessions. Trainees will be monitored by trained study personnel and at the end of the practicum training, the expert users will blindly review and assess the quality of each study using the standardized scale and competency scorecard provided below. Additionally, they will be asked to pass the knowledge quiz (80% or better). If competency is not achieved, an additional weekend of training can be added.
Primary Screening PhaseOther
Following certification, the certified MOH nurses will integrate echocardiographic screening into the routine workflow at the 4 HCIII/IV clinics with each nurse carrying out screening at the assigned HC on patients (aged 5-40) presenting to the health center for routine care.
Screening will be done daily over a period of one month. A minimum total of 400 participants will be screened during this period; each nurse will screen as many patients as they can, with a minimum of 100 participants (at least 5 participants per day). At the end of each screen, the trainees will interpret the screen as screen negative or screen positive. They will go ahead to refer participants identified as screen positives to the district hospital (LRRH) for a confirmatory echo.
At the end of each screening day, all images will be uploaded to a cloud server for a confirmatory review by a cardiology fellow or cardiology attending physician, within in 1 - 2 weeks.
Secondary Training PhaseOther
Each Primary Trained MOH Nurse will train 3 other nurses from their Health Center using pre-recorded PowerPoints.
Secondary Assessment PhaseOther
The secondarily trained nurses will be assessed and certified by the nurse trainer.
Secondary Screening PhaseOther
Following certification, the certified MOH nurses will integrate echocardiographic screening into the routine workflow at the 4 HCIII/IV clinics with each nurse carrying out screening at the assigned HC on patients (aged 5-40) presenting to the health center for routine care.
Screening will be done daily over a period of two months. A minimum total of 1200 participants will be screened during this period; each nurse will screen as many patients as they can, with a minimum of 100 participants. At the end of each screen, the trainees will interpret the study as screen negative or screen positive. They will go ahead to refer participants identified as screen positives to the district hospital (LRRH) for a confirmatory echo.
At the end of each screening day, all images will be uploaded to a cloud server for a confirmatory review by a cardiology fellow or cardiology attending physician, within in 1 - 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Primary Training | Experimental | 4 Ministry of Health nurses will be trained by expert trainers to become certified in focused echocardiography acquisition and interpretation in order to screen patients for rheumatic heart diseases Receives: Other: Primary Training Phase; Other: Primary Assessment Phase; Other: Primary Screening Phase |
| Secondary Training | Experimental | The 4 Ministry of Health nurses trained in Aim 1 will then train and certify 3 other nurses from their clinics in focused echocardiography acquisition interpretation. Receives: Other: Secondary Training Phase; Other: Secondary Assessment Phase; Other: Secondary Screening Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses
Diagnostic performance of MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers will be assessed. Diagnostic accuracy, sensitivity, specificity, positive and negative predictive values will be calculated to determine diagnostic performance of MOH nurses who have completed certification on focused echocardiography acquisition and interpretation. The ability of trainees to correctly identify screen positive and negative patients for RHD using known expert diagnosis as the reference. Correct determination of RHD screen positive/negative in at least 80% of cases is the benchmark
Measured: 2 months after completion of training
Secondary outcomes (8)
Knowledge Assessment
Questionnaire to test compare pre and post training knowledge about Rheumatic Heart Disease administered to nurse trainees.
Measured: Immediately before the training session and immediately after completion of training
Computer Based Testing
Computer based testing designed to determine positive and negative screening referrals of patients with RHD and other cardiac diseases
Measured: Immediately following training
Rapid Competency assessment
This assessment will be administered post training to nurse trainees. It is an observation- based assessment designed to assess correct use of the technology, basic image acquisition proficiency, diagnostic accuracy and image quality.
Measured: Immediately following training
Provider satisfaction
Surveys questions on training and screening experience along with guided discussions on the training and screening experiences will be administered to nurse trainees
Measured: Immediately post training
Longitudinal Image Quality
Expert Echocardiographers will access each image acquired by nurses using the ACEP scale. A scale of 1-5 (1) being no recognizable structure and (5) being excellent image quality of all structures. A score of 3 and above will be considered diagnostic.
Measured: Daily assessment for 1 month
Provider confidence
Nurses will subjectively report their level of confidence regarding image quality. The levels of confidence will be assessed. (1) Very confident, image quality is good and adequate for diagnosis. (2) Fairly confident, image is good but confirmation of diagnosis by expert trainer needed, (3) Not confident, image quality not adequate.
Measured: Daily assessment for 1 month
Diagnostic performance for other common categories of cardiac diseases
Assess nurse's ability to accurately identify left ventricular dysfunction and pericardial effusion as compared to the same standard applied by an expert.
Measured: Through completion of screening phase, average of 1 month
Time to certification
Determine the time from the first day of training to certification for participants including remediation time.
Measured: Trough first day of training to study completion, average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start3 Jan 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a two-phase cohort study that will determine the ability of MOH nurses to accurately integrate echocardiographic screening for rheumatic heart disease into primary healthcare clinics in Uganda.
- Masking
- None (open label)
- Enrolment
- 1,628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Heart Institute
- Responsible party
- Sponsor
- Investigators
- Andrea Z Beaton, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668611
- Sponsor's protocol ID
- 2022-0312
- Acronym
- ADD-RHD 2B
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation of a Train the Trainer Curriculum to Scale Up Automated Intelligence Supported Echocardiography for Rheumatic Heart Disease Screening in a Public Health Care System
- ClinicalTrials.gov ID
- NCT05668611
- Acronym / sponsor ID
- ADD-RHD 2B / 2022-0312
- Conditions
- Rheumatic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,628 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Uganda Heart Institute
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 30 Dec 2022 (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 first primary objective of this study is to determine the diagnostic performance (sensitivity and specificity) of primary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease. The second primary objective is to determine the diagnostic performance (sensitivity and specificity) of secondary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by MOH nurse trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease.
Detailed description
Objective 1:
4 ultrasound naïve nurses (Primary) employed at the HCIII/IVs participating in ADD-RHD Part 1 (SOMREC REF 2021-61) in Lira, will be trained and certified by experts in echocardiography for RHD on focused RHD echocardiographic screening examination and interpretation using a novel AI guided software.
Focused RHD screening echocardiograms by the 4 nurses will be integrated into routine clinical practice at their assigned HCIII/IVs for 1 month.
Screen positive patients will be referred to LRRH for confirmatory echocardiogram using a Standard echocardiographic machine under the National RHD registry (SOMREC REF 2014-137).
All echocardiograms will be uploaded to a secure cloud-based server and over-read by a cardiologist with in one - two (1 - 2) weeks to ensure patient safety and to determine trainee performance.
Diagnostic accuracy, sensitivity, specificity, positive and negative predictive values will be calculated.
4 MOH trainees will use pre-recorded PowerPoint presentations to conduct hands-on training for phase 2 (secondary) nurses.
Objective 2:
Similar to Phase 1 with just a few exceptions. 12 MOH nurses will be trained and certified by MOH nurse trainers from phase 1 to acquire and interpret RHD focused screening echocardiograms using a novel AI guided software.
Screening will be integrated into routine care for 2 months and diagnostic performance assessed.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-phase cohort study that will determine the ability of MOH nurses to accurately integrate echocardiographic screening for rheumatic heart disease into primary healthcare clinics in Uganda.
| Arm | Type | Receives |
|---|---|---|
| Primary Training | Experimental | Other: Primary Training Phase, Other: Primary Assessment Phase, Other: Primary Screening Phase4 Ministry of Health nurses will be trained by expert trainers to become certified in focused echocardiography acquisition and interpretation in order to screen patients for rheumatic heart diseases |
| Secondary Training | Experimental | Other: Secondary Training Phase, Other: Secondary Assessment Phase, Other: Secondary Screening PhaseThe 4 Ministry of Health nurses trained in Aim 1 will then train and certify 3 other nurses from their clinics in focused echocardiography acquisition interpretation. |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Attend same HCIII/IV sites that the MOH nurses work at
- Agree to participate via the study's informed consent
Key exclusion criteria (1 listed)
- Very sick participants requiring transfer to higher level facility or inpatient care
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 |
|---|---|---|
| Primary Training PhaseA four-day training program taken over the course of two weekends will include materials on RHD and RHD echocardiographic screening using focused artificial intelligence navigational guided echocardiographic acquisition to identify patients who are screen positive or screen negative for RHD. The echo protocol will be limited to the parasternal long axis-view (2D and color Doppler) focusing on mitral and aortic valve morphology and function and a single 2D apical 4 chamber view for auto EF. The curriculum package will include online modules, instructor delivered PowerPoint presentations, and hands on practice on volunteers with and without RHD. | Other | Primary Training |
| Primary Assessment PhaseA pre- and post-training test on RHD knowledge and diagnosis will be administered. A rapid competency assessment, including obtaining imaging on volunteers with or without RHD and an online test with pre-recorded cases of RHD, LV dysfunction and Pericardial effusions, will be utilized at the end of the 4-day training sessions. Trainees will be monitored by trained study personnel and at the end of the practicum training, the expert users will blindly review and assess the quality of each study using the standardized scale and competency scorecard provided below. Additionally, they will be asked to pass the knowledge quiz (80% or better). If competency is not achieved, an additional weekend of training can be added. | Other | Primary Training |
| Primary Screening PhaseFollowing certification, the certified MOH nurses will integrate echocardiographic screening into the routine workflow at the 4 HCIII/IV clinics with each nurse carrying out screening at the assigned HC on patients (aged 5-40) presenting to the health center for routine care. Screening will be done daily over a period of one month. A minimum total of 400 participants will be screened during this period; each nurse will screen as many patients as they can, with a minimum of 100 participants (at least 5 participants per day). At the end of each screen, the trainees will interpret the screen as screen negative or screen positive. They will go ahead to refer participants identified as screen positives to the district hospital (LRRH) for a confirmatory echo. At the end of each screening day, all images will be uploaded to a cloud server for a confirmatory review by a cardiology fellow or cardiology attending physician, within in 1 - 2 weeks. | Other | Primary Training |
| Secondary Training PhaseEach Primary Trained MOH Nurse will train 3 other nurses from their Health Center using pre-recorded PowerPoints. | Other | Secondary Training |
| Secondary Assessment PhaseThe secondarily trained nurses will be assessed and certified by the nurse trainer. | Other | Secondary Training |
| Secondary Screening PhaseFollowing certification, the certified MOH nurses will integrate echocardiographic screening into the routine workflow at the 4 HCIII/IV clinics with each nurse carrying out screening at the assigned HC on patients (aged 5-40) presenting to the health center for routine care. Screening will be done daily over a period of two months. A minimum total of 1200 participants will be screened during this period; each nurse will screen as many patients as they can, with a minimum of 100 participants. At the end of each screen, the trainees will interpret the study as screen negative or screen positive. They will go ahead to refer participants identified as screen positives to the district hospital (LRRH) for a confirmatory echo. At the end of each screening day, all images will be uploaded to a cloud server for a confirmatory review by a cardiology fellow or cardiology attending physician, within in 1 - 2 weeks. | Other | Secondary Training |
Primary outcome
RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses
Time frame: 2 months after completion of training
Diagnostic performance of MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers will be assessed. Diagnostic accuracy, sensitivity, specificity, positive and negative predictive values will be calculated to determine diagnostic performance of MOH nurses who have completed certification on focused echocardiography acquisition and interpretation. The ability of trainees to correctly identify screen positive and negative patients for RHD using known expert diagnosis as the reference. Correct determination of RHD screen positive/negative in at least 80% of cases is the benchmark
8 secondary outcomes
Knowledge Assessment
Time frame: Immediately before the training session and immediately after completion of training
Computer Based Testing
Time frame: Immediately following training
Rapid Competency assessment
Time frame: Immediately following training
Provider satisfaction
Time frame: Immediately post training
Longitudinal Image Quality
Time frame: Daily assessment for 1 month
Provider confidence
Time frame: Daily assessment for 1 month
Diagnostic performance for other common categories of cardiac diseases
Time frame: Through completion of screening phase, average of 1 month
Time to certification
Time frame: Trough first day of training to study completion, average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Andrea Z Beaton principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Training Phase, Primary Assessment Phase and Primary Screening Phase in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
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 2 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: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RHD Echocardiographic Diagnostic accuracy, sensitivity, specificity of MOH nurses (time frame: 2 months after completion of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2024.