NCT02212145

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 1988

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1988

Completed
26.2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

27.3 years

First QC Date

August 7, 2014

Last Update Submit

January 19, 2015

Conditions

Keywords

preventioncardiovascular diseaserisk factors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • A follow-up of drug treatment of diabetes, dyslipidemia and hypertension

    24 years

Other Outcomes (4)

  • Incidence and mortality in cancer

    24 years

  • Consumption of medical care overall and for different diagnostic groups

    24 years

  • Health economic aspects

    24 years

  • +1 more other outcomes

Study Arms (3)

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.

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 15 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Gunilla Journath, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 8, 2014

Study Start

June 1, 1988

Primary Completion

September 1, 2015

Study Completion

December 1, 2016

Last Updated

January 21, 2015

Record last verified: 2015-01