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Long-term Follow-up of the Helsinki Businessmen Study (HBS)

14. august 2015 opdateret af: Timo Strandberg, Helsinki University Central Hospital

Long-term Follow-up of the Helsinki Businessmen Study Cohort of Men Born in 1919-1934

The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up through national registers since the 1980, and since 2000 with regular questionnaire surveys. Latest in 2015. Also clinical and laboratory studies have been performed in random subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The Helsinki Businessmen Study (HBS) was originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups between 1964-1973, but since the beginning of 1970s it has developed into a clinico-epidemiological longitudinal study. Primary focus was on the prevention of cardiovascular diseases (CVD), but since 2000 focus has been shifting to geriatrics, and with its long follow-up (up to 50 years) HBS can be seen as a "life-course" study. Traditional CVD risk factors are available from the 1960s and in 1974 participants (available n=3310) were divided in groups according to their clinical status and CVD risk. Two high-risk groups (n=1222) and low-risk group (n=593) participated in a 5-year multifactorial primary prevention study in 1974-1980 (in-trial and post-trial results have been published in 1985 and 1991). The whole original cohort has been followed-up from national registers since 1985 and with regular questionnaire surveys since 2000. Random subcohorts have been studied clinically with laboratory and genetic examinations in 2003 and 2011. The latest questionnaire survey was performed in winter 2015 by which two thirds of the original cohort had died. Follow-up of the cohort is ongoing and new research questions formulated..

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3490

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

31 år til 46 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups during 1964-1973, but since the beginning of 1970s it has developed into a clinic-epidemiological longitudinal study.

Beskrivelse

Inclusion Criteria:

  • Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973

Exclusion Criteria:

  • Non-participants

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Total, observational
Various cardiovascular risk groups described below
High-risk intervention
Healthy but at high risk in 1974
Andet: Intervention
Multifactorial intervention with lifestyle changes and drugs as needed
High-risk control
Healthy but at high risk in 1974
Low-risk conrtol
Healthy and at low risk in 1974
Sick control
Medications or clinical disease in 1974
Refused
Refused or no response in 1974

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Total mortality: national registers
Tidsramme: change from baseline up to 612 months
change from baseline up to 612 months

Sekundære resultatmål

Resultatmål
Tidsramme
Health-related quality of life: questionnaire data
Tidsramme: change from baseline up to 612 months
change from baseline up to 612 months
Geriatric syndromes and disability: questionnaires, clinical examinations, registers
Tidsramme: change from baseline up to 612 months
change from baseline up to 612 months
Morbidity: self-report, national registers, hospital and autopsy records
Tidsramme: change from baseline up to 612 months
change from baseline up to 612 months
Medications: self-report, national registers
Tidsramme: change from baseline up to 612 months
change from baseline up to 612 months
Cause-specific mortality: national registers, autopsy records
Tidsramme: change from baseline up to 612 months
change from baseline up to 612 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Helsinki University Central Hospital

Efterforskere

  • Ledende efterforsker: Timo E Strandberg, MD, Helsinki University Central Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 1964

Primær færdiggørelse (Forventet)

1. december 2040

Studieafslutning (Forventet)

1. december 2040

Datoer for studieregistrering

Først indsendt

10. juni 2015

Først indsendt, der opfyldte QC-kriterier

14. august 2015

Først opslået (Skøn)

18. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HBS Group

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner