Follow-up of Sollentuna Prevention Program (SoPP)
19 januari 2015 uppdaterad av: Mai-Lis Hellénius, Professor, Karolinska Institutet
Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality
To evaluate long-term effects of one individual- and population-oriented cardiovascular prevention programs in primary care.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
1600000
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.
Tidsram: 24 years
|
Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries
|
24 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
A follow-up of drug treatment of diabetes, dyslipidemia and hypertension
Tidsram: 24 years
|
By using the drug register in Sweden do a follow-up of drug treatment in the cohort
|
24 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence and mortality in cancer
Tidsram: 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
Tidsram: 24 years
|
To study medical care consumption overall for different diagnostic groups by using different registers in Sweden
|
24 years
|
|
Health economic aspects
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Gunilla Journath, PhD, Karolinska Institutet
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 1988
Primärt slutförande (Förväntat)
1 september 2015
Avslutad studie (Förväntat)
1 december 2016
Studieregistreringsdatum
Först inskickad
7 augusti 2014
Först inskickad som uppfyllde QC-kriterierna
7 augusti 2014
Första postat (Uppskatta)
8 augusti 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 januari 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 januari 2015
Senast verifierad
1 januari 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20100473
- 2012/1172-31/1 (Annan identifierare: Regional Ethical Review Board, Stockholm)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .