- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786561
Depression, Anxiety and Social Relationships as Risk Factors for Dementia
Depression as Risk Factor for Dementia
Study Overview
Status
Detailed Description
The Health Study in Nord-Trondelag (HUNT) fulfils most of the key requirements of a population-representative cohort study by meeting the following elements: firm knowledge about the population denominator, knowledge about reasons for refusal (in line with previous methods in HUNT), options for levels and localisation of participation (at test station, at home, at nursing homes), coverage of sociodemographic features by the comprehensive HUNT4-protocol and register linkage, inclusion of institutionalized individuals and individuals with reduced capacity to consent, measurement of risk and compensatory factors across the life course by merging with previous results in HUNT surveys and linkage to registries, core elements and assessment methods can be compared with other European populations studies including elderly people, and finally, the ability to include biobank results in the data analysis. The HUNT data supplemented by register linkage include all established and suspected risk factors of dementia.
A particular focus on primary health care is appropriate because it is in this part of the health care system that the need for extra resources due to the substantial increase in dementia prevalence is most pronounced. Furthermore, preventive measures in a life-course perspective will mainly have to be implemented in the primary health care setting.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tønsberg, Norway
- Norwegian national advisory unit on Ageing and Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Living in designated area
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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HUNT4 70+
All inhabitants of Nord-Trøndelag 70 years or older were invited to participate in HUNT 4 70+.
HUNT4 refers to the fourth wave of the HUNT-study (HelseUndersøkelse i Nord-Trøndelag or health survey in northern part of Trøndelag community in Middle of Norway) and 70+ refers to the part of the survey directed to participants aged seventy years and older.
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HUNT4 70+ Trondheim
All inhabitants of one district in Trondheim 70 years or older were invited to participate in HUNT 4 70+
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of dementia diagnosis in HUNT4 70+ study
Time Frame: 2017-2019
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Two clinical and scientific experts will independently set at diagnosis of cognitive impairment or dementia based on all available information applying standard diagnostic criteria DSM-5.
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2017-2019
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Incidence of Minimal Cognitive Impairment (MCI) in the HUNT 70+ study
Time Frame: 2017-2019
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Two clinical and scientific experts will independently set at diagnosis of cognitive impairment or dementia based on all available information applying standard diagnostic criteria DSM-5.
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2017-2019
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in loneliness
Time Frame: 1995-2019
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Self-reported feeling of loneliness
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1995-2019
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Geir Selbæk, Phd, Norwegian national advisory unit on Ageing and Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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