DementiaCo-AiTNCT04792086
Disease Containment Measures Among Older Adults During the Covid-19 Pandemia
An observational study of Dementia and Cognitive Impairment, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cognitive Impairment, Depression, Anxiety
- How many people
- 12,000 participants
- Where
- 1 siteNorway
- Study dates
- 18 Feb 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Inhabitants living in the designated areas that volunteered to participation in the HUNT4 health survey
Who may be able to join
- Inhabitants living in the designated areas
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Norwegian National Advisory Unit of Ageing and Health
Tønsberg
Kari Midtbø Kristiansen
About this study
Official title: The Impact of the COVID-19 Epidemic on the Health of Older Adults
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.
Read the detailed description
Introduction: To prevent the spread of COVID-19 societies around the world have implemented various levels of lockdown strategies. Norway locked down major parts of the society from March 2020. Specifically, this meant that public services were closed (e.g. most in-home healthcare services, day care centres, group exercise/gyms and services that offer physiotherapy, medical and psychological consultation). For people with cognitive impairment and dementia, social distancing and self-isolation may have limited the use of normal strategies (e.g., distraction, stimulation, and social interaction) that are routinely adopted to manage some of the dementia symptoms, such as neuropsychiatric symptoms. A lack of daily routines may change the clinical conditions of patients with dementia. Worsening of preexisting and/or the onset of new neuropsychiatric symptoms may occur, in addition to a possible decline of cognitive and functional capacities
Aim: The overarching aim of this project is to provide decision makers with vital information to improve the healthcare of people with dementia and cognitive impairment in the context of an epidemic.
Method: We will use four data sources:1) The fourth wave of the Trøndelag Health study (HUNT, HUNT4 70+), 2) Three national health registries (The Norwegian Patient Registry (NPR), the Norwegian Registry for Primary Health Care (NRPHC) and the Norwegian Prescription Database (NorPD)), 3) A postal questionnaire concerning social isolation during the COVID-19 epidemic, and 4) The Ageing in Trøndelag study (AiT), which is a follow-up of the HUNT4 70+ study.
With this linkage of cohort data and national health registry data, we can identify factors that may make people with cognitive impairment and dementia vulnerable to loss of healthcare services because of COVID-19 and subsequently to negative health consequences.
- Conditions
- Dementia, Cognitive Impairment, Depression, Anxiety, Loneliness
- Keywords
- Dementia, Pandemic, Health care services, Population study, Older adults, Depression
- Medical subject headings
- Dementia, Cognitive Dysfunction, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Health care services
Information from the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (NRPHC)
Measured: 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)
Measured: 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)
Measured: The participants' use of health care services from the period 2021-2022
Use of psychotropic medications
Information from the Norwegian Prescription Database (NorPD)
Measured: The participants' use of psychotropic medication from the period 2017-2019
Use of psychotropic medications
Information from the Norwegian Prescription Database (NorPD)
Measured: The participants' use of psychotropic medication in 2020
Use of psychotropic medications
Information from the Norwegian Prescription Database (NorPD)
Measured: The participants' use of psychotropic medication from the period 2021-2022
Secondary outcomes (4)
Montreal Cognitive Assessment scale
Tests cognitive function in the domain's memory, visuospatial and executive functions, attention, concentration, language and orientation. Scores from 0 - 30 where 30 indicates best function. impairment or dementia, and questions on subjective memory decline
Measured: 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
Tests immediate and delayed memory. Scores from 0 - 30 in immediate memory and 0-10 in delayed recall, higher scores indicates better function.
Measured: 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
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
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start18 Feb 2021
- Primary completion20 Mar 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Centre for Ageing and Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geir Selbaek, PhD, Study director, Norwegian National Advisory Unit on Ageing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792086
- Sponsor's protocol ID
- COVID19-AIT
- Acronym
- Co-AiT
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Jun;48(3):4313-4325. doi: 10.1007/s11357-025-01909-x. Epub 2025 Sep 27.
PubMed 41006671Ibsen 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.
PubMed 40338168Ibsen 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.
PubMed 39920618Ibsen 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.
PubMed 38641570
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the COVID-19 Epidemic on the Health of Older Adults
- ClinicalTrials.gov ID
- NCT04792086
- Acronym / sponsor ID
- Co-AiT / COVID19-AIT
- Conditions
- Dementia, Cognitive Impairment, Depression, Anxiety, Loneliness
- Keywords
- Dementia, Pandemic, Health care services, Population study, Older adults, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Norwegian Centre for Ageing and HealthUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: To prevent the spread of COVID-19 societies around the world have implemented various levels of lockdown strategies. Norway locked down major parts of the society from March 2020. Specifically, this meant that public services were closed (e.g. most in-home healthcare services, day care centres, group exercise/gyms and services that offer physiotherapy, medical and psychological consultation). For people with cognitive impairment and dementia, social distancing and self-isolation may have limited the use of normal strategies (e.g., distraction, stimulation, and social interaction) that are routinely adopted to manage some of the dementia symptoms, such as neuropsychiatric symptoms. A lack of daily routines may change the clinical conditions of patients with dementia. Worsening of preexisting and/or the onset of new neuropsychiatric symptoms may occur, in addition to a possible decline of cognitive and functional capacities
Aim: The overarching aim of this project is to provide decision makers with vital information to improve the healthcare of people with dementia and cognitive impairment in the context of an epidemic.
Method: We will use four data sources:1) The fourth wave of the Trøndelag Health study (HUNT, HUNT4 70+), 2) Three national health registries (The Norwegian Patient Registry (NPR), the Norwegian Registry for Primary Health Care (NRPHC) and the Norwegian Prescription Database (NorPD)), 3) A postal questionnaire concerning social isolation during the COVID-19 epidemic, and 4) The Ageing in Trøndelag study (AiT), which is a follow-up of the HUNT4 70+ study.
With this linkage of cohort data and national health registry data, we can identify factors that may make people with cognitive impairment and dementia vulnerable to loss of healthcare services because of COVID-19 and subsequently to negative health consequences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Inhabitants living in the designated areas that volunteered to participation in the HUNT4 health survey
Key inclusion criteria (1 listed)
- Inhabitants living in the designated areas
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Use of Health care services
Time frame: The participants' use of health care services from the period 2017-2019
Information from the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (NRPHC)
Use of Health care services
Time frame: The participants' use of health care services in 2020
Information from the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (NRPHC)
Use of Health care services
Time frame: The participants' use of health care services from the period 2021-2022
Information from the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (NRPHC)
Use of psychotropic medications
Time frame: The participants' use of psychotropic medication from the period 2017-2019
Information from the Norwegian Prescription Database (NorPD)
Use of psychotropic medications
Time frame: The participants' use of psychotropic medication in 2020
Information from the Norwegian Prescription Database (NorPD)
Use of psychotropic medications
Time frame: The participants' use of psychotropic medication from the period 2021-2022
Information from the Norwegian Prescription Database (NorPD)
4 secondary outcomes
Montreal Cognitive Assessment scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 41006671Ibsen 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. 2026 Jun;48(3):4313-4325. doi: 10.1007/s11357-025-01909-x. Epub 2025 Sep 27.
- Derived from this study: PubMed 40338168Ibsen 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.
- Derived from this study: PubMed 39920618Ibsen 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.
- Derived from this study: PubMed 38641570Ibsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir Selbaek, PhD study director
Norwegian National Advisory Unit on Ageing and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Cognitive Impairment, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanja Louise Ibsen (+95881287, tanja.ibsen@aldringoghelse.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Health care services (time frame: The participants' use of health care services from the period 2017-2019). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04792086, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.