- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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.
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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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.
Временное ограничение: 24 years
|
Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries
|
24 years
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
A follow-up of drug treatment of diabetes, dyslipidemia and hypertension
Временное ограничение: 24 years
|
By using the drug register in Sweden do a follow-up of drug treatment in the cohort
|
24 years
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Incidence and mortality in cancer
Временное ограничение: 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
Временное ограничение: 24 years
|
To study medical care consumption overall for different diagnostic groups by using different registers in Sweden
|
24 years
|
Health economic aspects
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Gunilla Journath, PhD, Karolinska Institutet
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 20100473
- 2012/1172-31/1 (Другой идентификатор: Regional Ethical Review Board, Stockholm)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .