Follow-up of Sollentuna Prevention Program

Cardiovascular Diseases Clinical Trial

— SoPP  

Official title:

Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02212145
• Other study ID #: 20100473
• Secondary ID: 2012/1172-31/1
• Status: Active, not recruiting
• Phase: N/A
• First received: August 7, 2014
• Last updated: January 19, 2015
• Start date: June 1988
• Est. completion date: December 2016

Study information

• Verified date: January 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

To evaluate long-term effects of one individual- and population-oriented cardiovascular prevention programs in primary care.

Description:

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.

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600000
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Swedish Heart Lung Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and mortality in cancer	Incidence and mortality in cancer - a twenty year follow-up by using the swedish cancer register	24 years	No
Other	Consumption of medical care overall and for different diagnostic groups	To study medical care consumption overall for different diagnostic groups by using different registers in Sweden	24 years	No
Other	Health economic aspects	Health economic aspects such as; health care consumption in total and for different diagnostic groups; care costs; impact on indirect costs (lost working years and sick leave); intervention cost will be studied	24 years	No
Other	Time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality	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	No
Primary	Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.	Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries	24 years	No
Secondary	A follow-up of drug treatment of diabetes, dyslipidemia and hypertension	By using the drug register in Sweden do a follow-up of drug treatment in the cohort	24 years	No