Disease Containment Measures Among Older Adults During the Covid-19 Pandemia

Dementia Clinical Trial

— Co-AiT  

Official title:

The Impact of the COVID-19 Epidemic on the Health of Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792086
• Other study ID #: COVID19-AIT
• Status: Recruiting
• Start date: February 18, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Norwegian Centre for Ageing and Health
• Contact: Tanja Louise Ibsen
• Phone: +95881287
• Email: tanja.ibsen[@]aldringoghelse.no
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: December 31, 2025
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Inhabitants living in the designated areas

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cognitive Impairment
• Dementia
• Depression
• Depression, Anxiety
• Loneliness

Locations

Country	Name	City	State
Norway	Norwegian National Advisory Unit of Ageing and Health	Tønsberg

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Centre for Ageing and Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	Use of psychotropic medications	Information from the Norwegian Prescription Database (NorPD)	The participants' use of psychotropic medication from the period 2017-2019
Primary	Use of psychotropic medications	Information from the Norwegian Prescription Database (NorPD)	The participants' use of psychotropic medication in 2020
Primary	Use of psychotropic medications	Information from the Norwegian Prescription Database (NorPD)	The participants' use of psychotropic medication from the period 2021-2022
Secondary	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
Secondary	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
Secondary	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
Secondary	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