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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03013725
Other study ID # HUSK9799
Secondary ID
Status Completed
Phase N/A
First received December 19, 2016
Last updated January 5, 2017
Start date January 1992
Est. completion date June 1999

Study information

Verified date January 2017
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority Chief county medical office, Hordaland county
Study type Observational

Clinical Trial Summary

The Hordaland Health Studies (HHS) were conducted in 1992-93 (The Homocysteine study) and in 1997-99 (HUSK). Both surveys were conducted as a joint project between the University of Bergen, the Norwegian Health Screening Service (SHUS) (now part of the National Institute of Public Health) and the Municipal Health Service in Hordaland.

The main focus of the studies is on chronic diseases including cardiovascular disease, cancer, osteoporosis, anxiety and depression. Some projects focus on psychosocial factors, occupational research, musculoskeletal diseases, urinary incontinence and mapping of drug use. The main purpose of the surveys is to gather information so that disease ultimately can be prevented.

Approximately 36,000 residents of Hordaland county participated in the studies, ca. 18,000 in 1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who participated in the 1992-93 survey also participated in 1997-99.


Recruitment information / eligibility

Status Completed
Enrollment 36000
Est. completion date June 1999
Est. primary completion date June 1999
Accepts healthy volunteers No
Gender All
Age group 40 Years to 74 Years
Eligibility Inclusion Criteria:

- Born in a specific time-period

- From Hordaland County

- Community-dwelling people who were able to come to the study site on their own, and able to fill out questionnaires.

Exclusion Criteria:

- Not born within the specific time-period

- Not from Hordaland County

- Institutionalized People

- People who were not able to fill out questionnaires

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Bergen Part of CONOR, and participates in the Norwegian Epidemiologic Osteoporosis Studies

Outcome

Type Measure Description Time frame Safety issue
Primary Total mortality. The unique 11-digit personal identification number assigned to all Norwegian residents facilitates linkage between HHS and the Norwegian Population Register, which contains information on vital status (alive, emigrated, or dead). The follow-up period varies from 16 - 23 years, depending on whether first or second measurement is used as baseline. Participants are followed from baseline (1992-93 or 1997-99) until death or December 31st, 2015. No
Secondary Mortality or morbidity from chronic diseases (for example cardiovascular disease, cancer). Also, award of disability pension are used as an outcome. The Cause of Death Registry, Cancer Registry of Norway, CVDNOR and FD-trygd (a national database of Health and social benefits) will be used to get information on outcomes. The last day of follow-up for cardiovascular disease is December 31st, 2014. The last day of follow-up for cancer is December 31st, 2014.
The last day of follow-up for Cause of Death is December 31st, 2014. The follow-up period for cardiovascular disease varies from 15 - 22 years, depending on whether first or second measurement is used as baseline.
The follow-up period for cancer varies from 15 - 22 years, depending on whether first or second measurement is used as baseline.
Participants are followed from baseline (1992-93 or 1997-99) until time of diagnosis/death from disease or the last day of follow-up. No
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