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Follow-up of Sollentuna Prevention Program (SoPP)

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ClinicalTrials.gov Identifier: NCT02212145
Recruitment Status : Unknown
Verified January 2015 by Mai-Lis Hellénius, Professor, Karolinska Institutet.
Recruitment status was:  Active, not recruiting
First Posted : August 8, 2014
Last Update Posted : January 21, 2015
Sponsor:
Collaborator:
Swedish Heart Lung Foundation
Information provided by (Responsible Party):
Mai-Lis Hellénius, Professor, Karolinska Institutet

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

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 1600000 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality
Study Start Date : June 1988
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2016

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.



Primary Outcome Measures :
  1. Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program. [ Time Frame: 24 years ]
    Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries


Secondary Outcome Measures :
  1. A follow-up of drug treatment of diabetes, dyslipidemia and hypertension [ Time Frame: 24 years ]
    By using the drug register in Sweden do a follow-up of drug treatment in the cohort


Other Outcome Measures:
  1. Incidence and mortality in cancer [ Time Frame: 24 years ]
    Incidence and mortality in cancer - a twenty year follow-up by using the swedish cancer register

  2. Consumption of medical care overall and for different diagnostic groups [ Time Frame: 24 years ]
    To study medical care consumption overall for different diagnostic groups by using different registers in Sweden

  3. Health economic aspects [ Time Frame: 24 years ]

    Health economic aspects such as

    1. health care consumption in total and for different diagnostic groups
    2. care costs
    3. impact on indirect costs (lost working years and sick leave)
    4. intervention cost will be studied

  4. Time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality [ Time Frame: 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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212145


Sponsors and Collaborators
Karolinska Institutet
Swedish Heart Lung Foundation
Investigators
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Principal Investigator: Gunilla Journath, PhD Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mai-Lis Hellénius, Professor, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02212145     History of Changes
Other Study ID Numbers: 20100473
2012/1172-31/1 ( Other Identifier: Regional Ethical Review Board, Stockholm )
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Mai-Lis Hellénius, Professor, Karolinska Institutet:
prevention
cardiovascular disease
risk factors
Additional relevant MeSH terms:
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Cardiovascular Diseases