Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01550068
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2012-03-07
Brief Title:
Rheumatic Heart Disease School Project
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
A Population-Based Study of Prevalence of Rheumatic Heart Disease and Cardiovascular Outcomes Among Schoolchildren in Nepal
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute rheumatic Fever ARF results from an autoimmune response due to molecular mimicry between the M-protein on the group A β-hemolytic streptococci GABHS cell membrane and cardiac myosin and may lead through recurrent or sustained inflammation to Rheumatic Heart Disease RHD RHD remains a major contributor to morbidity and premature death in the working age population in Nepal Secondary prevention with regular oral or intravenous administration of penicillin continued until early adulthood is recommended to prevent the progression of the development of endocarditis and subsequent valvular dysfunction
Screening for rheumatic heart disease using echocardiography has the potential to detect rheumatic valvular lesions at an earlier clinically silent stage as compared to clinical examination alone and might have a beneficial impact on long-term outcome of children with RHD Schoolchildren aged 5-16 years from several public and private schools from rural and urban areas in Southeastern Nepal will be screened for RHD using portable echocardiography
Three main inter-related objectives will be pursued in three phases of the study In a first phase using a cross sectional approach the prevalence of clinical and subclinical RHD will be investigated among a representative sample of schoolchildren from public and private schools in urban and rural areas In a second phase using a cohort study approach among those children diagnosed at different stages of RHD clinical outcomes with regular medical surveillance will be assessed a and clinical and social risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis will be determined b A third phase will integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on health resource utilization
Screening for rheumatic heart disease using echocardiography has the potential to detect rheumatic valvular lesions at an earlier clinically silent stage as compared to clinical examination alone and might have a beneficial impact on long-term outcome of children with RHD Schoolchildren aged 5-16 years from several public and private schools from rural and urban areas in Southeastern Nepal will be screened for RHD using portable echocardiography
Three main inter-related objectives will be pursued in three phases of the study In a first phase using a cross sectional approach the prevalence of clinical and subclinical RHD will be investigated among a representative sample of schoolchildren from public and private schools in urban and rural areas In a second phase using a cohort study approach among those children diagnosed at different stages of RHD clinical outcomes with regular medical surveillance will be assessed a and clinical and social risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis will be determined b A third phase will integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on health resource utilization
Detailed Description:
Background
Acute rheumatic Fever ARF results from an autoimmune response due to molecular mimicry between the M-protein on the group A β-hemolytic streptococci GABHS cell membrane and cardiac myosin and may lead through recurrent or sustained inflammation to Rheumatic Heart Disease RHD 1 RHD is reported to affect over 15 million people worldwide and remains a major contributor to morbidity and premature death in the working age population in developing countries 2 Socioeconomic determinants such as poverty overcrowding and malnutrition have been related to RHD The prevalence of ARF and RHD seems to be particularly high in Southeast Asia the Western Pacific and Africa 3 Whereas heart murmurs detected on clinical examination may indicate clinically manifest RHD echocardiographic screening revealed ten times higher prevalence rates of RHD among schoolchildren 4 and may help diagnose RHD at an earlier clinically silent stage
Patients with a past medical history of ARF or RHD are recommended secondary prevention with regular oral or intravenous administration of penicillin continued until early adulthood
Even though preventive measures with penicillin are inexpensive and efficient this strategy is difficult to effectuate in developing countries with limited access to health care resources
A recent study proved that enrolling patients with ARF and RHD in a registry with close follow-up increases compliance to treatment and thus helps in reducing the cardiovascular sequelae associated with disease progression 5
The prevalence of RHD among schoolchildren in urban and rural areas in Nepal is largely unknown and risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis need to be determined Moreover the impact of screening using echocardiography detecting RHD at an earlier clinically silent stage of RHD on health resource utilization has to be determined
Objective
Originally three main inter-related objectives were to be pursued in three phases of the study In the first phase using a cross sectional approach the prevalence of clinical and subclinical RHD were to be investigated among a representative sample of schoolchildren from public and private schools in urban and rural areas In the second phase using a cohort study approach among those children diagnosed at different stages of RHD clinical outcomes with regular medical surveillance were to be assessed a and clinical and social risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis were to be determined b A third phase was to integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on quality of life and health resource utilization
On August 14 2013 the Nepal Health Research Council required the introduction of a control group in the design of the Rheumatic Heart Disease RHD School Project The original design included a random sampling stratified by urban versus rural location and public versus private status of schools with a computer-generated random sequence used to determine which schools would be centrally selected during Phase 1 of the project to undergo screening for RHD The original computer-generated random sequence was therefore used to determine which schools would be randomly selected as control schools which did not undergo the screening intervention during Phase 1 but would be selected for follow-up during Phase 2 of the project This approach implicitly allowed for a cluster randomized comparison between intervention and control schools at follow-up in children aged 5 to 12 years at baseline when phase 1 of the study took place
Methods
The project will employ three types of study designs performed in sequential phases a cross sectional study part 1 a longitudinal cohort study part 2 and an analysis of the impact of screening secondary prevention and treatment on health resource utilization part 3
1 Part 1 Cross-Sectional Survey Schoolchildren aged 5-16 years will be screened at selected schools in the Southeast area of Nepal A follow-up examination will be performed in a subset of schools that underwent screening at baseline and in all control schools allowing for a cluster randomized comparison at follow-up between schools that underwent screening at baseline and control schools in children aged 5 to 12 years at baseline
2 Part 2 Longitudinal Cohort Study Those children with documented history of ARF andor RHD will be included into a prospective registry and receive secondary prevention will be followed on a regular basis
3 Part 3 Impact of Screening and Treatment of RHD The third phase will integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on health resource utilization
Acute rheumatic Fever ARF results from an autoimmune response due to molecular mimicry between the M-protein on the group A β-hemolytic streptococci GABHS cell membrane and cardiac myosin and may lead through recurrent or sustained inflammation to Rheumatic Heart Disease RHD 1 RHD is reported to affect over 15 million people worldwide and remains a major contributor to morbidity and premature death in the working age population in developing countries 2 Socioeconomic determinants such as poverty overcrowding and malnutrition have been related to RHD The prevalence of ARF and RHD seems to be particularly high in Southeast Asia the Western Pacific and Africa 3 Whereas heart murmurs detected on clinical examination may indicate clinically manifest RHD echocardiographic screening revealed ten times higher prevalence rates of RHD among schoolchildren 4 and may help diagnose RHD at an earlier clinically silent stage
Patients with a past medical history of ARF or RHD are recommended secondary prevention with regular oral or intravenous administration of penicillin continued until early adulthood
Even though preventive measures with penicillin are inexpensive and efficient this strategy is difficult to effectuate in developing countries with limited access to health care resources
A recent study proved that enrolling patients with ARF and RHD in a registry with close follow-up increases compliance to treatment and thus helps in reducing the cardiovascular sequelae associated with disease progression 5
The prevalence of RHD among schoolchildren in urban and rural areas in Nepal is largely unknown and risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis need to be determined Moreover the impact of screening using echocardiography detecting RHD at an earlier clinically silent stage of RHD on health resource utilization has to be determined
Objective
Originally three main inter-related objectives were to be pursued in three phases of the study In the first phase using a cross sectional approach the prevalence of clinical and subclinical RHD were to be investigated among a representative sample of schoolchildren from public and private schools in urban and rural areas In the second phase using a cohort study approach among those children diagnosed at different stages of RHD clinical outcomes with regular medical surveillance were to be assessed a and clinical and social risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis were to be determined b A third phase was to integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on quality of life and health resource utilization
On August 14 2013 the Nepal Health Research Council required the introduction of a control group in the design of the Rheumatic Heart Disease RHD School Project The original design included a random sampling stratified by urban versus rural location and public versus private status of schools with a computer-generated random sequence used to determine which schools would be centrally selected during Phase 1 of the project to undergo screening for RHD The original computer-generated random sequence was therefore used to determine which schools would be randomly selected as control schools which did not undergo the screening intervention during Phase 1 but would be selected for follow-up during Phase 2 of the project This approach implicitly allowed for a cluster randomized comparison between intervention and control schools at follow-up in children aged 5 to 12 years at baseline when phase 1 of the study took place
Methods
The project will employ three types of study designs performed in sequential phases a cross sectional study part 1 a longitudinal cohort study part 2 and an analysis of the impact of screening secondary prevention and treatment on health resource utilization part 3
1 Part 1 Cross-Sectional Survey Schoolchildren aged 5-16 years will be screened at selected schools in the Southeast area of Nepal A follow-up examination will be performed in a subset of schools that underwent screening at baseline and in all control schools allowing for a cluster randomized comparison at follow-up between schools that underwent screening at baseline and control schools in children aged 5 to 12 years at baseline
2 Part 2 Longitudinal Cohort Study Those children with documented history of ARF andor RHD will be included into a prospective registry and receive secondary prevention will be followed on a regular basis
3 Part 3 Impact of Screening and Treatment of RHD The third phase will integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on health resource utilization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None