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

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

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1600000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. The screened group who participated in the cardiovascular prevention program:

   (n=5938) and the rest of the population in Sollentuna Municipality.

2. 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.
3. 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and mortality in cancer	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	To study medical care consumption overall for different diagnostic groups by using different registers in Sweden	24 years
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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Swedish Heart Lung Foundation
• Investigators: Principal Investigator: Gunilla Journath, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Journath G, Hammar N, Elofsson S, Linnersjo A, Vikstrom M, Walldius G, Krakau I, Lindgren P, de Faire U, Hellenius ML. Time Trends in Incidence and Mortality of Acute Myocardial Infarction, and All-Cause Mortality following a Cardiovascular Prevention Program in Sweden. PLoS One. 2015 Nov 18;10(11):e0140201. doi: 10.1371/journal.pone.0140201. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: June 1, 1988
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 19, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: cardiovascular disease; risk factors; prevention
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 20100473; 2012/1172-31/1 (Other Identifier: Regional Ethical Review Board, Stockholm)