NCT04792086

Brief Summary

This study will examine which impact lockdown strategies intending to prevent the spread of COVID-19 had on people with cognitive impairment and dementia. Comprehensive data from two large health studies in Norway, conducted before and after the COVID-19 outbreak, will be linked with health register data on the use of health care services and medication. Further, it will be conducted a survey addressing questions on social isolation and use of communicative technology, from March 2020 to January 2021. The knowledge gained from this study can improve the health care system's ability to respond more adequately to pandemics and other unforeseen events, so that the negative consequences for older adults with dementia and cognitive impairment can be reduced.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

February 2, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

February 2, 2021

Last Update Submit

March 20, 2024

Conditions

Keywords

DementiaPandemicHealth care servicesPopulation studyOlder adultsDepression

Outcome Measures

Primary Outcomes (6)

  • Use of Health care services

    Information from the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (NRPHC)

    The participants' use of health care services from the period 2017-2019

  • Use of Health care services

    Information from the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (NRPHC)

    The participants' use of health care services in 2020

  • Use of Health care services

    Information from the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (NRPHC)

    The participants' use of health care services from the period 2021-2022

  • Use of psychotropic medications

    Information from the Norwegian Prescription Database (NorPD)

    The participants' use of psychotropic medication from the period 2017-2019

  • Use of psychotropic medications

    Information from the Norwegian Prescription Database (NorPD)

    The participants' use of psychotropic medication in 2020

  • Use of psychotropic medications

    Information from the Norwegian Prescription Database (NorPD)

    The participants' use of psychotropic medication from the period 2021-2022

Secondary Outcomes (4)

  • Montreal Cognitive Assessment scale

    The participants were assessed when attending the HUNT4 70+-study, and will be assessed with the same measures in the followup study in 2021/2022

  • CERAD Ten-words test

    The participants were assessed when attending the HUNT4 70+-study, and will be assessed with the same measures in the followup study in 2021/2022

  • Incidence of dementia diagnosis

    The participants were assessed when attending the HUNT4 70+-study, and will be assessed with the same measures in the followup study in 2021/2022

  • Incidence of mild cognitive impairment

    The participants were assessed when attending the HUNT4 70+-study, and will be assessed with the same measures in the followup study in 2021/2022

Other Outcomes (12)

  • Short Physical Performance Battery

    The participants were assessed when attending the HUNT4 70+-study, and will be assessed with the same measures in the followup study in 2021/2022.

  • Grip strength

    The participants were assessed when attending the HUNT4 70+-study, and will be assessed with the same measures in the followup study in 2021/2022.

  • Blood Pressure

    The participants were assessed when attending the HUNT4 70+-study, and will be assessed with the same measures in the followup study in 2021/2022

  • +9 more other outcomes

Study Arms (2)

Inhabitants in Nord-Trøndelag 70 years of age and older

All inhabitants in Nord-Trøndelag 70 years of age and older, who participated in the HUNT4 70+-study, between 2017 and 2019.

Inhabitants in one area in Trondheim, 70 years of age and older

All inhabitants one area in Trondheim, 70 years of age and older, who participated in the HUNT4 70+-study, between 2017 and 2019.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inhabitants living in the designated areas that volunteered to participation in the HUNT4 health survey

You may qualify if:

  • Inhabitants living in the designated areas

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian National Advisory Unit of Ageing and Health

Tønsberg, Norway

RECRUITING

Related Publications (4)

  • Ibsen TL, Zotcheva E, Bergh S, Gerritsen D, Livingston G, Luras H, Mamelund SE, Rokstad AMM, Strand BH, Voshaar RCO, Selbaek G. Cognitive function, physical function, and mental health in older adults amid reduced primary and specialist healthcare service use during COVID-19: the HUNT study. Geroscience. 2025 Sep 27. doi: 10.1007/s11357-025-01909-x. Online ahead of print.

  • Ibsen TL, Zotcheva E, Bergh S, Gerritsen D, Livingston G, Luras H, Mamelund SE, Mork Rokstad AM, Strand BH, Thingstad P, Oude Voshaar RC, Selbaek G. The Role of Social Media in Mitigating the Long-Term Impact of Social Isolation on Mental and Cognitive Health in Older Adults During the COVID-19 Pandemic: The HUNT Study. Int J Geriatr Psychiatry. 2025 May;40(5):e70097. doi: 10.1002/gps.70097.

  • Ibsen TL, Zotcheva E, Bergh S, Gerritsen D, Livingston G, Luras H, Mamelund SE, Rokstad AMM, Strand BH, Oude Voshaar RC, Selbaek G. A longitudinal cohort study on dispensed analgesic and psychotropic medications in older adults before, during, and after the COVID-19 pandemic: the HUNT study. BMC Geriatr. 2025 Feb 7;25(1):85. doi: 10.1186/s12877-025-05745-8.

  • Ibsen TL, Strand BH, Bergh S, Livingston G, Luras H, Mamelund SE, Voshaar RO, Rokstad AMM, Thingstad P, Gerritsen D, Selbaek G. A longitudinal cohort study on the use of health and care services by older adults living at home with/without dementia before and during the COVID-19 pandemic: the HUNT study. BMC Health Serv Res. 2024 Apr 19;24(1):485. doi: 10.1186/s12913-024-10846-y.

MeSH Terms

Conditions

DementiaCognitive DysfunctionDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersBehavioral SymptomsBehavior

Study Officials

  • Geir Selbaek, PhD

    Norwegian National Advisory Unit on Ageing and Health

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

March 10, 2021

Study Start

February 18, 2021

Primary Completion

March 20, 2024

Study Completion

December 31, 2025

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations