Disease Containment Measures Among Older Adults During the Covid-19 Pandemia (Co-AiT)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Dementia; Loneliness; Depression, Anxiety

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 Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Tanja Louise Ibsen; Phone Number: +95881287; Email: tanja.ibsen@aldringoghelse.no

Study Locations

• Norway
  • Tønsberg, Norway
    • Recruiting
    • Norwegian National Advisory Unit of Ageing and Health
    • Contact: Kari Midtbø Kristiansen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Inhabitants living in the designated areas

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery	The test combines the results of the gait speed, chair stand and balance 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.
Grip strength	Measured in both hands with a Jamar and digital dynamometer	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	Systolic 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
Body mass index	Weight and height will be combined to report BMI in kg/m^2	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
Upper arm circumference	The circumference Is measured in centimeters	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
The Hospital Anxiety and Depression scale	Gathers information on anxiety and depression, scores from 0 - 42 where 0 indicates best function	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
Alcohol consumption	Innhouse made questionnaire about average alcohol units per week and/or month	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
Physical Self-Maintenance scale	Assess problems with personal activities of daily living. Assessed in proxy interview and by health personnel for participants in institutions, scores function in 6 personal activities, lower scores indicates better function	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
Instrumental Activities of daily function	Assess problems with instrumental activities of daily living, scores function in 8 instrumental activities, lower scores indicates better function	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
Social isolation	Questions on the experience of social isolation as a result of containment measures due to covid-19, including information on the level of isolation; accepting visits from friends, family or health care services, and restrictions about outdoor activities	The participants receive a postal questionnaire in Januar 2021, regarding the period from March 2020-January 20201
Fear of Covid-19	A seven-item scale on fear of covid-19, rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree) with scores ranging from 7 to 35. The higher the score, the greater the fear of COVID-19	The participants receive a postal questionnaire in Januar 2021, regarding the period from March 2020-January 20201
The use of information and communicative technology (ICT)	Questions on the use of ICT, including questions on keeping contact with familly, friend and health care personnel	The participants receive a postal questionnaire in Januar 2021, regarding the period from March 2020-January 20201

Collaborators and Investigators

• Sponsor: Norwegian Centre for Ageing and Health
• Investigators: Study Director: Geir Selbaek, PhD, Norwegian national advisory unit on Ageing and Health

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Actual): March 20, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Dementia; Older adults; Pandemic; Population study; Health care services
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Depression; Dementia
• Other Study ID Numbers: COVID19-AIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No