- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02212145
Follow-up of Sollentuna Prevention Program (SoPP)
Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality
Descripción general del estudio
Estado
Condiciones
Descripción detallada
In Sweden there are unique opportunities to create a relevant comparison group for this study, which is of great importance to the value of this cohort study.
Of the three study populations two (2-3)will be created by using national registries.
- The screened group consists of the individuals (n = 5938) who had direct contact with the prevention program, ie undergone a voluntary opportunistic cardiovascular screening (questionnaire, physical examination and testing in connection with visits to health centers) and the rest of all individuals who lived in Sollentuna Municipality between 1988-1993.
- Relatives of individuals included in the screened group who lived in Stockholm county at the time of the intervention will be identified by the use of the Medical Birth Register and the Multi-Generation Register. Family members are defined as parents, siblings and children and husband / wife to those in thescreened group and will be analyzed in the same way as those who participated in the intervention for risk of developing cardiovascular disease and cancer.
- The comparison group consists of the entire population of Stockholm County minus Sollentuna 1988-93, taking into account population changes (migration, birth, death) during the period.
This three populations will be followed-up in national registries and databases
All subjects will be monitored for example disease history, socio-economics and biochemical risk factors presented below national registries and research databases. When all the matches of national registers and a local register (AMORIS)have been done the database will de-identified and anonymized data to be available for statistical processing.
Tipo de estudio
Inscripción (Anticipado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The screened group who participated in the cardiovascular prevention program:
(n=5938) and the rest of the population in Sollentuna Municipality.
- To the screened group matched "controls" will be selected randomly from the population of Stockholm County minus Sollentuna. The population in Sollentuna will compared to the population of Stockholm County minus Sollentuna Municipality.
- Relatives of individuals included in the intervention group and who lived in Stockholm County at the time of the intervention will be identified by use of national registers.
Descripción
Inclusion Criteria in the risk intervention group:
- Individuals 15 years of age or more who visited three (four) health care centres in Sollentuna 1988-1993 were offered to participate in the prevention program
Exclusion Criteria in the screened intervention group:
- Age < 15 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Screened group
Screened group is defined as those individuals who were willing to participate in the cardiovascular prevention program and all the individuals who lived in Sollentuna during the intervention.
|
|
Relatives to the screened group
Relatives to individuals included in the screened group, who lived in Stockholm County at least during one year at the time of the intervention.
|
|
Control group
Matched "controls" is going to be selected randomly from the population of Stockholm County minus Sollentuna Municipality with relevant background factors.
The whole population will be used as a comparison group when evaluating the result from all the municipality of Sollentuna during 1988-1993.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.
Periodo de tiempo: 24 years
|
Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries
|
24 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
A follow-up of drug treatment of diabetes, dyslipidemia and hypertension
Periodo de tiempo: 24 years
|
By using the drug register in Sweden do a follow-up of drug treatment in the cohort
|
24 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence and mortality in cancer
Periodo de tiempo: 24 years
|
Incidence and mortality in cancer - a twenty year follow-up by using the swedish cancer register
|
24 years
|
|
Consumption of medical care overall and for different diagnostic groups
Periodo de tiempo: 24 years
|
To study medical care consumption overall for different diagnostic groups by using different registers in Sweden
|
24 years
|
|
Health economic aspects
Periodo de tiempo: 24 years
|
Health economic aspects such as
|
24 years
|
|
Time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality
Periodo de tiempo: 24 years
|
To study time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality by use of National Swedish registries.
|
24 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gunilla Journath, PhD, Karolinska Institutet
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20100473
- 2012/1172-31/1 (Otro identificador: Regional Ethical Review Board, Stockholm)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .