Rheumatic Heart DiseaseNEPAL4NCT05504928
Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease
A study testing School nurse program in people with Rheumatic Heart Disease and Rheumatic Heart Disease in Children, run by Insel Gruppe AG, University Hospital Bern at 1 site in Nepal.
Trial summary
The overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic… Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease, Rheumatic Heart Disease in Children
- What is being tested?
- School nurse program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jun 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 5-16 years
- Attending Tulsi Secondary Boarding School in Tulsipur, Nepal.
Who cannot join
- Children / primary caregivers not providing informed consent to participate
- Children not attending Tulsi Secondary Boarding School in Tulsipur.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site, 1 recruiting
- Recruiting
Tulsi Secondary Boarding School
Tulsi̇̄pur, 22412
Krishna Agrawal, Prof. Dr., +9779857045721, agrawalkris@gmail.com
About this study
Official title: Effectiveness of a School-centered Primary and Secondary Prevention Program on Prevalence of Latent Rheumatic Heart Disease
The overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic heart disease.
Read the detailed description
Three in four children worldwide grow up in regions of the world where patterns of acute rheumatic fever and rheumatic heart disease are endemic and where rheumatic heart disease accounts for >300'000 deaths every year. Evidence from a systematic review and meta-analysis of 10 studies indicated an incidence of group A β-hemolytic streptococcal (GAHBS) pharyngitis among children in low- to upper-middle income countries of 10.8 per 100 child-years with considerable heterogeneity between individual reports.
Timely detection of GAHBS pharyngitis by use of rapid antigen detection tests and initiation of antibiotic treatment represents an effective target for primary prevention. Early stages of rheumatic heart disease manifest with morphologic or functional valvular changes that can only be detected with echocardiography and are therefore latent. Latent stages of rheumatic heart disease are reversible with timely initiation of secondary antibiotic prophylaxis. A school-centered approach provides an opportunity to provide equitable access to a primary and secondary prophylaxis program with the potential to substantially reduce the burden of rheumatic heart disease in endemic regions.
All children 5-16 years of age from Tulsi Secondary Boarding School in Tulsipur, Nepal, will be eligible for inclusion. Sociodemographic characteristics and will be collected by means of a standardized interview. In a study using an interrupted time series design, prevalence of latent rheumatic heart disease will be measured by means of transthoracic echocardiography before, and two and four years after implementation of a dedicated school nurse program providing health care through assessment, intervention and follow-up of GAHBS pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease.
Investigators expect to find a decrease in prevalence of rheumatic heart disease after implementation of a dedicated school-centered prevention program primarily led by school nurses, and to identify sociodemographic and environmental factors associated with the development and progression of rheumatic heart disease.
- Being tested
- School nurse program
- Keywords
- Rheumatic Heart Disease, Primary Prevention, Secondary Prevention, Screening
- 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.
School nurse programOther
School nurse program providing health care through assessment, intervention and follow-up of group A β-hemolytic streptococcal pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Implementation of a dedicated school nurse program | Experimental | School nurse program providing health care through assessment, intervention and follow-up of group A β-hemolytic streptococcal pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease. Receives: Other: School nurse program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of definite or borderline Rheumatic Heart Disease
Prevalence of definite or borderline Rheumatic Heart Disease according to the criteria of the World Heart Federation as assessed by systematic echocardiographic screening
Measured: 4 years
Secondary outcomes (4)
Group A β-hemolytic streptococcal pharyngitis
Number of patients with group A β-hemolytic streptococcal pharyngitis within study participation
Measured: 4 years
Acute rheumatic fever
Number of patients with acute rheumatic fever within study participation
Measured: 4 years
Rheumatic heart disease
Number of patients with rheumatic heart disease within study participation
Measured: 4 years
Adverse reactions to penicillin injections
Number of patients with adverse reactions to penicillin injections within study participation
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interrupted time series design
- Masking
- None (open label)
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Pilgrim, Prof. Dr., Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504928
- Sponsor's protocol ID
- NEPAL4
- Acronym
- NEPAL4
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. doi: 10.1016/S1473-3099(05)70267-X.
PubMed 16253886Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.
PubMed 22405798Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
PubMed 28834488Pearce S, Bowen AC, Engel ME, de la Lande M, Barth DD. The incidence of sore throat and group A streptococcal pharyngitis in children at high risk of developing acute rheumatic fever: A systematic review and meta-analysis. PLoS One. 2020 Nov 18;15(11):e0242107. doi: 10.1371/journal.pone.0242107. eCollection 2020.
PubMed 33206687
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a School-centered Primary and Secondary Prevention Program on Prevalence of Latent Rheumatic Heart Disease
- ClinicalTrials.gov ID
- NCT05504928
- Acronym / sponsor ID
- NEPAL4 / NEPAL4
- Keywords
- Rheumatic Heart Disease, Primary Prevention, Secondary Prevention, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Aug 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 overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic heart disease.
Detailed description
Three in four children worldwide grow up in regions of the world where patterns of acute rheumatic fever and rheumatic heart disease are endemic and where rheumatic heart disease accounts for >300'000 deaths every year. Evidence from a systematic review and meta-analysis of 10 studies indicated an incidence of group A β-hemolytic streptococcal (GAHBS) pharyngitis among children in low- to upper-middle income countries of 10.8 per 100 child-years with considerable heterogeneity between individual reports.
Timely detection of GAHBS pharyngitis by use of rapid antigen detection tests and initiation of antibiotic treatment represents an effective target for primary prevention. Early stages of rheumatic heart disease manifest with morphologic or functional valvular changes that can only be detected with echocardiography and are therefore latent. Latent stages of rheumatic heart disease are reversible with timely initiation of secondary antibiotic prophylaxis. A school-centered approach provides an opportunity to provide equitable access to a primary and secondary prophylaxis program with the potential to substantially reduce the burden of rheumatic heart disease in endemic regions.
All children 5-16 years of age from Tulsi Secondary Boarding School in Tulsipur, Nepal, will be eligible for inclusion. Sociodemographic characteristics and will be collected by means of a standardized interview. In a study using an interrupted time series design, prevalence of latent rheumatic heart disease will be measured by means of transthoracic echocardiography before, and two and four years after implementation of a dedicated school nurse program providing health care through assessment, intervention and follow-up of GAHBS pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease.
Investigators expect to find a decrease in prevalence of rheumatic heart disease after implementation of a dedicated school-centered prevention program primarily led by school nurses, and to identify sociodemographic and environmental factors associated with the development and progression of rheumatic heart disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interrupted time series design
| Arm | Type | Receives |
|---|---|---|
| Experimental: Implementation of a dedicated school nurse program | Experimental | Other: School nurse programSchool nurse program providing health care through assessment, intervention and follow-up of group A β-hemolytic streptococcal pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 5-16 years
- Attending Tulsi Secondary Boarding School in Tulsipur, Nepal.
Key exclusion criteria (2 listed)
- Children / primary caregivers not providing informed consent to participate
- Children not attending Tulsi Secondary Boarding School in Tulsipur.
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 |
|---|---|---|
| School nurse programSchool nurse program providing health care through assessment, intervention and follow-up of group A β-hemolytic streptococcal pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease. | Other | Experimental: Implementation of a dedicated school nurse program |
Primary outcome
Prevalence of definite or borderline Rheumatic Heart Disease
Time frame: 4 years
Prevalence of definite or borderline Rheumatic Heart Disease according to the criteria of the World Heart Federation as assessed by systematic echocardiographic screening
4 secondary outcomes
Group A β-hemolytic streptococcal pharyngitis
Time frame: 4 years
Acute rheumatic fever
Time frame: 4 years
Rheumatic heart disease
Time frame: 4 years
Adverse reactions to penicillin injections
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Background: PubMed 16253886Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. doi: 10.1016/S1473-3099(05)70267-X.
- Background: PubMed 22405798Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.
- Background: PubMed 28834488Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
- Background: PubMed 33206687Pearce S, Bowen AC, Engel ME, de la Lande M, Barth DD. The incidence of sore throat and group A streptococcal pharyngitis in children at high risk of developing acute rheumatic fever: A systematic review and meta-analysis. PLoS One. 2020 Nov 18;15(11):e0242107. doi: 10.1371/journal.pone.0242107. eCollection 2020.
- 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.
Thomas Pilgrim, Prof. Dr. principal investigator
Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School nurse program in people with Rheumatic Heart Disease and Rheumatic Heart Disease in Children, run by Insel Gruppe AG, University Hospital Bern at 1 site in Nepal.
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 2 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: looking for participants now, as of the sponsor's last update on 17 Aug 2022. 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 Nepal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Pilgrim, Prof. Dr. (0041316325000, kardio.studien@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of definite or borderline Rheumatic Heart Disease (time frame: 4 years). 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 NCT05504928, which also lists 4 linked publications.
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 17 Aug 2022.