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.
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.
Other: Telephone interview
Sociodemographic data. Clinical data. PMCI/MD quality of life, cognition, depression, technophilia and perceived stress and caregiver quality of life and burden assessments.
Inclusion Criteria:
- Having participated in the SMART 4 MD, TV-AssistDem and INFINITy clinical trials
Instituto de Investigacion Biomedica de Malaga-IBIMA
Málaga, Spain
Fermín Mayoral-Cleries, Principal Investigator
Instituto de Investigación Biomédica de Malaga (IBIMA)