Clinical trial NCT05379426: Older Adults' Perceptions of the Impact COVID-19 Pandemic
Official title: Older Adults' Perceptions About the Impact of COVID-19 Pandemic on Their Cognitive, Emotional and Social Status: A Multicentre Mixed Methods Study in Institutions Providing Care and Supporting Services for Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Depression, Anxiety
Cognitive Impairment
Quality of Life
Loneliness
Keywords: older adults
COVID-19
cognitive function
executive function
mood
depression
anxiety
loneliness
quality of life
Lead sponsor: Rsocialform - Geriatria, Lda
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 880
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In each participating institution, users who meet the inclusion criteria will be assigned to answer/fill in the assessment instruments. Prior to the enrolment in the study, informed consent will be obtained from participants after they have received information about the study. This information will include the purpose of the study, the assessment procedures adopted, the data processing procedures in accordance with current legislation, the voluntary nature of participation in the study and the right to withdraw consent at any time without affecting the services received in the institution.

Brief summary: This multicentre study will be conduct in several Portuguese institutions, which provide care and supporting services for older adults, with aim to assess the impact of COVID-19 pandemic on the cognitive, emotional and social status of their beneficiaries. Initially, data on global cognitive function, executive function, mood, anxiety, loneliness, and quality of life will be collected. Secondly, a semi-structured interview will be carried out to realize and understand what were the major difficulties experienced by the older adult during the pandemic period.

Detailed description: The pandemic COVID-19 imposed the mobilisation of institutions providing care and supporting services for older adults, and the adoption of new habits on a large scale and in a very short period of time. The need to change daily routines proved to be particularly impactful among older adults, since these citizens, due to their vulnerability to adverse health outcomes and the need for additional protection against the exposure to the risk of viral infection, were subjected to more demanding and inflexible containment measures (Organisation for Economic Co-operation and Development, 2020). The confinement measures resulted in considerable restriction of independence and access to supportive social networks, making it necessary to use compensatory solutions, such as the use of digital technologies and the resolution of emerging problems remotely. However, given that, as suggested by recent statistical data (European Commission, 2020; European Union, 2020), a large proportion of older adults do not have access to suitable equipment or lack adequate digital skills, the effective and satisfactory mobilisation of these compensatory solutions depended, in many cases, on the involvement of others. As a result, older adults saw their personal autonomy compromised and their relationships with other people highly limited. The confinement measures also resulted in the abandonment of at least some healthy living habits (moments of conviviality, cognitive stimulation activities, physical exercise and recreational activities carried out in groups, etc.), which are essential for the maintenance of physical and cognitive capacities, contributing to the increase of well-being and quality of life.

Taking into account the duration of the COVID-19 pandemic, it is necessary to understand its impact on the cognitive, emotional, and social status of older adults. Our proposal focuses on older adults who benefit from care and support services (e.g., long-term care centres, day and social centres, home support services), in which the pandemic mitigation measures were particularly rigorous, being supported by contingency plans constantly updated according to the guidelines issued by the Portuguese Directorate-General of Health and supervisory entities.

Eligibility criteria: Inclusion Criteria:

* Aged 65 or over.
* Native Portuguese speakers.
* Have handed in the project informed consent, duly completed and signed, after prior information.
* Communication and comprehension skills.
* Have been attending a care and support services for the older adults for at least two years.

Exclusion Criteria:

* Severe sensory and physical limitations or an acute or serious illness preventing participation in the study.
* Evidence of aggressive and disruptive behaviour, as indicated by the reference technicians of the institution where the participant attends a care and support services.
* Consumption of psychoactive substances and/or taking neuroleptics or antipsychotics in the last two months.
* Presence of a score lower than 10 points in the Mini Mental State Examination.

Primary outcomes:
measure: Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
timeFrame: baseline
measure: Executive functions assessed through Frontal Assessment Battery (FAB)
timeFrame: baseline
measure: Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: baseline
measure: Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)
timeFrame: baseline
measure: Loneliness assessed through Loneliness Scale 3 Portuguese version (UCLA)
timeFrame: baseline
measure: Quality of life assessed through Quality of Life - Alzheimer's Disease (QoL-AD)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
measure: Sociodemographic information gathered through the sociodemographic questionnaire
timeFrame: baseline
measure: Difficulties experienced by the older adult during the pandemic period gathered through the semi-structured interview
timeFrame: baseline
Locations:
city: Albergaria-a-Velha
country: Portugal
facility: Santa Casa da Misericórdia de Albergaria-a-Velha
state: Aveiro
city: Albergaria-a-Velha
country: Portugal
facility: Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
state: Aveiro
city: Angra Do Heroísmo
country: Portugal
facility: Santa Casa da Misericórdia de Angra do Heroísmo
state: Açores
city: Angra Do Heroísmo
country: Portugal
facility: Lar Recolhimento Jesus Maria José - Mónicas
state: Açores
city: Calheta
country: Portugal
facility: Santa Casa da Misericórdia da Calheta
state: Açores
city: Horta
country: Portugal
facility: Santa Casa da Misericórdia da Horta
state: Açores
city: Praia Da Vitória
country: Portugal
facility: Lar D. Pedro V
state: Açores
city: Praia Da Vitória
country: Portugal
facility: Centro Comunitário de São Brás
state: Açores
city: Velas
country: Portugal
facility: Casa de Repouso João Inácio de Sousa
state: Açores
city: Vila do Porto
country: Portugal
facility: Santa Casa da Misericórdia de Vila do Porto
state: Açores
city: Mértola
country: Portugal
facility: Santa Casa da Misericórdia de Mértola
state: Beja
city: Mirandela
country: Portugal
facility: Santa Casa da Misericórdia de Mirandela
state: Bragança
city: Apúlia
country: Portugal
facility: ASCRA - Associação Social, Cultural e Recreativa de Apúlia
state: Braga
city: Barcelos
country: Portugal
facility: Santa Casa da Misericórdia de Barcelos
state: Braga
city: Vieira do Minho
country: Portugal
facility: Centro Social da Paróquia de Vieira do Minho
state: Braga
city: Vila Velha de Rodão
country: Portugal
facility: Santa Casa da Misericórdia de Vila Velha de Rodão
state: Castelo Branco
city: Lousã
country: Portugal
facility: Santa Casa da Misericórdia da Lousã
state: Coimbra
city: Portimão
country: Portugal
facility: Santa Casa da Misericórdia de Portimão
state: Faro
city: Peva
country: Portugal
facility: Associação dos Amigos de Peva
state: Guarda
city: Alcobaça
country: Portugal
facility: Santa Casa da Misericórdia de Alcobaça
state: Leiria
city: Alvaiázere
country: Portugal
facility: Santa Casa da Misericórdia de Alvaiázere
state: Leiria
city: Alvorge
country: Portugal
facility: Santa Casa da Misericórdia de Alvorge
state: Leiria
city: Alcabideche
country: Portugal
facility: Centro Social e Paroquial Alcabideche
state: Lisboa
city: Alhandra
country: Portugal
facility: Associação do Hospital Civil e Misericórdia de Alhandra
state: Lisboa
city: Carnide
country: Portugal
facility: APOIARTE - Associação de Apoio aos Artistas
state: Lisboa
city: Oeiras
country: Portugal
facility: Centro Social Paroquial de Oeiras
state: Lisboa
city: Torres Vedras
country: Portugal
facility: Associação de Socorros da Freguesia de Turcifal
state: Lisboa
city: Funchal
country: Portugal
facility: Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau
state: Madeira
city: Arez
country: Portugal
facility: Santa Casa da Misericórdia de Arez
state: Portalegre
city: Avis
country: Portugal
facility: Santa Casa da Misericórdia de Avis
state: Portalegre
city: Elvas
country: Portugal
facility: Lar Júlio Alcântara Botelho
state: Portalegre
city: Penafiel
country: Portugal
facility: Lar e Centro de Dia Padre Américo
state: Porto
city: Trofa
country: Portugal
facility: Santa Casa da Misericórdia da Trofa
state: Porto
city: Rio Maior
country: Portugal
facility: Santa Casa da Misericórdia de Rio Maior
state: Santarém
city: Caminha
country: Portugal
facility: Santa Casa da Misericórdia de Caminha
state: Viana Do Castelo
city: Ponte de Lima
country: Portugal
facility: Santa Casa da Misericórdia de Ponte de Lima
state: Viana Do Castelo
city: Vila Nova de Cerveira
country: Portugal
facility: Santa Casa da Misericórdia de Vila Nova de Cerveira
state: Viana Do Castelo
city: Abraveses
country: Portugal
facility: A.S.S.F.A.
state: Viseu
city: Tarouca
country: Portugal
facility: Santa Casa da Misericórdia de Tarouca
state: Viseu
city: Vouzela
country: Portugal
facility: Santa Casa da Misericórdia de Vouzela
state: Viseu
city: Aveiro
country: Portugal
facility: Fundação Casa do Pessoal da Segurança Social e Saúde do Distrito de Aveiro
city: Bragança
country: Portugal
facility: Obra Social Padre Miguel
city: Braga
country: Portugal
facility: Associação Grupo Desportivo e Social Penso Santo Estevão
city: Braga
country: Portugal
facility: Centro Zulmira Pereira Simões
city: Castelo Branco
country: Portugal
facility: Santa Casa da Misericórdia de Castelo Branco
city: Castelo Branco
country: Portugal
facility: Residência Sénior D. António
city: Coimbra
country: Portugal
facility: Centro Social Rocha Barros
city: Guarda
country: Portugal
facility: Fundação João Bento Raimundo
city: Leiria
country: Portugal
facility: Centro Social Paroquial da Ilha - Obra Social da Sagrada Família
city: Lisboa
country: Portugal
facility: Centro Social Paroquial São Mamede
city: Lisboa
country: Portugal
facility: Associação Casapiana de Solidariedade
city: Lisboa
country: Portugal
facility: Fundação AFID Diferença
city: Lisboa
country: Portugal
facility: Centro Comunitário e Paroquial da Ramada
city: Porto
country: Portugal
facility: Centro Social Paroquial de Oliveira do Douro
city: Porto
country: Portugal
facility: Associação de Solidariedade Social S. Tiago de Rebordões
city: Viana Do Castelo
country: Portugal
facility: Centro Social e Cultural de Carreço
city: Vila Real
country: Portugal
facility: Centro Social Paroquial de Mateus
city: Montemor-o-Novo
country: Portugal
facility: Santa Casa da Misericórdia de Montemor-o-Novo
state: Évora
Study officials:
affiliation: Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
name: Susana I Justo Henriques, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
name: Elzbieta Bobrowicz Campos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
name: João L Alves Apóstolo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: