Clinical trial NCT04792086: Disease Containment Measures Among Older Adults During the Covid-19 Pandemia
Official title: The Impact of the COVID-19 Epidemic on the Health of Older Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Cognitive Impairment
Depression, Anxiety
Loneliness
Keywords: Dementia
Pandemic
Health care services
Population study
Older adults
Depression
Lead sponsor: Norwegian Centre for Ageing and Health
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 12000
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inhabitants living in the designated areas that volunteered to participation in the HUNT4 health survey

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.

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.

Eligibility criteria: Inclusion Criteria:

* Inhabitants living in the designated areas

Exclusion Criteria:

* None

Primary outcomes:
measure: Use of Health care services
timeFrame: The participants' use of health care services from the period 2017-2019
measure: Use of Health care services
timeFrame: The participants' use of health care services in 2020
measure: Use of Health care services
timeFrame: The participants' use of health care services from the period 2021-2022
measure: Use of psychotropic medications
timeFrame: The participants' use of psychotropic medication from the period 2017-2019
measure: Use of psychotropic medications
timeFrame: The participants' use of psychotropic medication in 2020
measure: Use of psychotropic medications
timeFrame: The participants' use of psychotropic medication from the period 2021-2022
Secondary outcomes:
measure: Montreal Cognitive Assessment scale
timeFrame: 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
measure: CERAD Ten-words test
timeFrame: 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
measure: Incidence of dementia diagnosis
timeFrame: 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
measure: Incidence of mild cognitive impairment
timeFrame: 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:
measure: Short Physical Performance Battery
timeFrame: 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.
measure: Grip strength
timeFrame: 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.
measure: Blood Pressure
timeFrame: 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
measure: Body mass index
timeFrame: 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
measure: Upper arm circumference
timeFrame: 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
measure: The Hospital Anxiety and Depression scale
timeFrame: 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
measure: Alcohol consumption
timeFrame: 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
measure: Physical Self-Maintenance scale
timeFrame: 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
measure: Instrumental Activities of daily function
timeFrame: 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
measure: Social isolation
timeFrame: The participants receive a postal questionnaire in Januar 2021, regarding the period from March 2020-January 20201
measure: Fear of Covid-19
timeFrame: The participants receive a postal questionnaire in Januar 2021, regarding the period from March 2020-January 20201
measure: The use of information and communicative technology (ICT)
timeFrame: The participants receive a postal questionnaire in Januar 2021, regarding the period from March 2020-January 20201
Locations:
city: Tønsberg
country: Norway
facility: Norwegian National Advisory Unit of Ageing and Health
Study officials:
affiliation: Norwegian National Advisory Unit on Ageing and Health
name: Geir Selbaek, PhD
role: STUDY_DIRECTOR
References: