Clinical trial NCT04385797: Cognitive Outcomes During COVID-19 confiNemeNt in Elderly and Their Caregivers Using Technologies for DEMentia
Official title: Cognitive Outcomes During COVID-19 confiNemeNt in Elderly and Their Caregivers Using Technologies for DEMentia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Dementia
Keywords: COVID-19
Social Isolation
Informal caregivers
Cognition
Facilities and Services Utilization
Technologies
ICTs
Telehealth
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling older adults with mild cognitive impairment or mild dementia

Brief summary: Coronavirus disease 2019 has forced worldwide the implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine and home confinement. This restriction of daily life activities and separation from loved ones may lead to social isolation and loneliness with health-related consequences in community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, an inadequate access to healthcare and social support services may aggravate chronic conditions. Technology home-based interventions emerge for combating social isolation and loneliness preventing the risk of viral exposure.

The aim of this multicentre cohort study is to explore, analyze and determine the impact of social isolation on: 1) cognition, quality of life, mood, technophilia and perceived stress of community-dwelling older adults with mild cognitive impairment or mild dementia, and on caregiver burden; 2) health and social care services access and utilization, and 3) cognitive, social and entertainment use of ICTs.

This study will be conducted in two Spanish regions Andalucía (Málaga) and Cataluña (Tarrasa). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregiver will be contacted by telephone. Potential respondents will be participants of the SMART 4 MD (N=100) and TV-AssistDem (N=100) clinical trials.

The change in means in the variables will be analyzed comparing baseline results in the previous studies with those during and after confinement using the ANOVA test of repeated measures or the non-parametric Friedman test if appropriate. The performance of a multivariate analysis of variance (ANCOVA) to introduce possible covariates will also be contemplated. A 95% confidence level will be used.

Detailed description: Coronavirus disease 2019 (COVID-19) has forced worldwide government authorities to implement unprecedented restrictions to control its rapid spread and mitigate its impact. In response to the outbreak, Spain declared by royal decree (463/2020) a national emergency, with the exceptional measure of a Nationwide lockdown enforcing social distancing, quarantine of those exposed to the disease and home confinement of those who remain healthy allowing only essential outings. This home-confinement by restriction of movement of daily life activities and social distancing from loved ones may be a challenging and unpleasant experience for those who undergo it, experiencing social isolation and loneliness with health-related consequences. Vulnerable populations at higher risk are fragile community-dwelling older adults whose chronic conditions may be aggravated by the consequences of the confinement and in particular, people with mild cognitive impairment or mild dementia.

QUALITY ASSURANCE PLAN. Researchers will report and review the process during the trial covering participant enrolment, consent, follow-up, policies to protect participants, including reporting of harm and completeness, accuracy, and timelines of data collection.

STANDARD OPERATING PROCEDURES. Participants will be interviewed by telephone. Potential respondents will be participants of the SMART 4 MD (NCT03325699) and TV-AssistDem (NCT03653234) clinical trials, which all aim to assess the effects of ICTs to support dementia: using a tablet-based health application, an intelligent system and a TV-based assistive integrated service, respectively.

Baseline assessments prior to the COVID-19 confinement (T0) of cognition, quality of life, depression, and technophilia of the PMCI/MD and caregiver burden will be compared with assessments carried out during the confinement measures (T1) and after the termination of the measures (T2). Additionally, perceived stress regarding the confinement situation will be measured at T1 and T2.

Participants will not receive financial reimbursement for taking part in this trial.

DATA DICTIONARY. All variables collected in this study are listed and described in an electronic Case Report Form (CRF), with associated guidelines, to ensure consistency in all gathered data. The following data will be collected in this trial:

Mini-Mental State Examination (MMSE) Quality of Life-Alzheimer's Disease Scale (QoL-AD Scale) European Quality of Life 5 Dimensions 3 Levels (EuroQoL-5D-3L) Geriatric Depression Scale (GDS) Instrument for Measuring Older People's Attitudes Toward Technology (TechPH) Perceived Stress Scale (PSS) Zarit Burden Interview (ZBI-12)

Other data: Sociodemographical data. Medical history - PMCI/MD only. Health perception-management: Change of living arrangements due to lockdown, presence of COVID-19 symptoms in PMCI/MD and/or relatives, access to COVID-19 information, devices used (SmartPhone, Tablet, Computer, Smart-TV, other), understanding of the information and contact with healthcare and social resources to manage the situation. Ability to manage illnesses, medication, changes and/or cancellations of previous medical appointments, renewal of prescriptions and provision of supports for the purchase of medication and food. Coping-stress tolerance: Mental health and well-being self-perceived mood. Sleep-rest : Alterations in usual sleep patterns and use of additional medication. Leisure activities: including preferred physical, intellectual, recreational and social activities. Social support: social connectedness (telephone call, video call, texting...), devices used (SmartPhone, Tablet, Computer, Smart-TV, other)

STATISTICS ANALYSIS PLAN. The flow of participants will be shown schematically with counts and percentages in a CONSORT diagram. All variables collected will be summarized at baseline and at follow-up. Statistics considered for presentation for continuous measures in summary tables will be the mean, minima and maxima, and standard deviation, and if the criteria of normality are not met, the median and the first and third quartiles. Categorical variables will be summarized using counts and percentages. The change in means in the study variables will be analyzed with respect to the results during the previous studies (SMART 4 MD and TV-AssistDem) with those currently collected using the ANOVA test of repeated measures or the non-parametric Friedman test if appropriate. The performance of a multivariate analysis of variance (ANCOVA) to introduce possible covariates will also be contemplated. A 95% confidence level will be used for all comparisons. The R version 3.6.1 program will be used. for all statistical analysis.

PLAN FOR MISSING DATA. Each researcher is responsible for ensuring that any missing data will be reported as missing in the study database. Procedures can sometimes be considered when using statistical methods that fail in the presence of any missing values, or when in the case of multiple-predictor statistical models all the data for an individual would be omitted because of a missing value in one of the predictors.

METHODS TO ENSURE VALIDITY AND QUALITY OF DATA. Accurate and reliable data collection will be assured by verification and cross-check of the CRF. Discrepancies and queries will be generated accordingly in the CRF for online resolution by the researcher. In addition, the CRF data will be reviewed on an ongoing basis for scientific plausibility.

Eligibility criteria: Inclusion Criteria:

* Having participated in the SMART 4 MD, TV-AssistDem and INFINITy clinical trials

Primary outcomes:
measure: Change on cognitive function in people with mild cognitive impairment or mild dementia prior to, during and after confinement.
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Change on quality of life in Alzheimer´s Disease in people with mild cognitive impairment or mild dementia prior to, during and after confinement.
timeFrame: Through study completion, an average of 6 months
measure: Change on quality of life in people with mild cognitive impairment or mild dementia prior to, during and after confinement.
timeFrame: Through study completion, an average of 6 months
measure: Change on mood in people with mild cognitive impairment or mild dementia prior to, during and after confinement.
timeFrame: Through study completion, an average of 6 months
measure: Change on technophilia in people with mild cognitive impairment or mild dementia prior to, during and after confinement.
timeFrame: Through study completion, an average of 6 months
measure: Change on perceived stress in people with mild cognitive impairment or mild dementia during and after confinement.
timeFrame: Through study completion, an average of 6 months
measure: Change on caregiver burden prior to, during and after confinement.
timeFrame: Through study completion, an average of 6 months
measure: Change on healthcare and social support services access prior to, during and after confinement.
timeFrame: Through study completion, an average of 6 months
measure: Change from health, cognitive, social, informative and entertainment related uses of ICT during and after confinement.
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Instituto de Investigacion Biomedica de Malaga-IBIMA
Study officials:
affiliation: Instituto de Investigación Biomédica de Malaga (IBIMA)
name: Fermín Mayoral-Cleries
role: PRINCIPAL_INVESTIGATOR
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