The Hordaland Health Study (HUSK)

January 5, 2017 updated by: Grethe Seppola Tell, University of Bergen

The Hordaland Health Studies (HHS)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Approximately 36,000 residents of Hordaland county participated in the studies (both men and women), 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The Homocysteine Study
Conducted in 1992-93, ca. 18000 participated.
Other: No intervention
No intervention
The Hordaland Health Study (HUSK)
Conducted in 1997-99, ca. 26000 participated.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total mortality.
Time Frame: Participants are followed from baseline (1992-93 or 1997-99) until death or December 31st, 2015.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality or morbidity from chronic diseases (for example cardiovascular disease, cancer). Also, award of disability pension are used as an outcome.
Time Frame: Participants are followed from baseline (1992-93 or 1997-99) until time of diagnosis/death from disease or the last day of follow-up.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bergen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Part of CONOR, and participates in the Norwegian Epidemiologic Osteoporosis Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1992

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 1999

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUSK9799

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol
    Information comments: Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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