Older Adults' Perceptions of the Impact COVID-19 Pandemic

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379426
• Other study ID #: 13052022
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2022
• Source: Rsocialform - Geriatria, Lda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• COVID-19
• COVID-19 Pandemic
• Depression
• Depression, Anxiety
• Loneliness
• Quality of Life

Intervention

Other:
• Impact COVID-19 pandemic
Battery of screening tests and the semi-structured interview focusing on the difficulties experienced by the older adult during the pandemic period.

Locations

Country	Name	City	State
Portugal	A.S.S.F.A.	Abraveses	Viseu
Portugal	Cediara - Associação de Solidariedade Social de Ribeira de Fráguas	Albergaria-a-Velha	Aveiro
Portugal	Santa Casa da Misericórdia de Albergaria-a-Velha	Albergaria-a-Velha	Aveiro
Portugal	Centro Social e Paroquial Alcabideche	Alcabideche	Lisboa
Portugal	Santa Casa da Misericórdia de Alcobaça	Alcobaça	Leiria
Portugal	Associação do Hospital Civil e Misericórdia de Alhandra	Alhandra	Lisboa
Portugal	Santa Casa da Misericórdia de Alvaiázere	Alvaiázere	Leiria
Portugal	Santa Casa da Misericórdia de Alvorge	Alvorge	Leiria
Portugal	Lar Recolhimento Jesus Maria José - Mónicas	Angra Do Heroísmo	Açores
Portugal	Santa Casa da Misericórdia de Angra do Heroísmo	Angra Do Heroísmo	Açores
Portugal	ASCRA - Associação Social, Cultural e Recreativa de Apúlia	Apúlia	Braga
Portugal	Santa Casa da Misericórdia de Arez	Arez	Portalegre
Portugal	Fundação Casa do Pessoal da Segurança Social e Saúde do Distrito de Aveiro	Aveiro
Portugal	Santa Casa da Misericórdia de Avis	Avis	Portalegre
Portugal	Santa Casa da Misericórdia de Barcelos	Barcelos	Braga
Portugal	Associação Grupo Desportivo e Social Penso Santo Estevão	Braga
Portugal	Centro Zulmira Pereira Simões	Braga
Portugal	Obra Social Padre Miguel	Bragança
Portugal	Santa Casa da Misericórdia da Calheta	Calheta	Açores
Portugal	Santa Casa da Misericórdia de Caminha	Caminha	Viana Do Castelo
Portugal	APOIARTE - Associação de Apoio aos Artistas	Carnide	Lisboa
Portugal	Residência Sénior D. António	Castelo Branco
Portugal	Santa Casa da Misericórdia de Castelo Branco	Castelo Branco
Portugal	Centro Social Rocha Barros	Coimbra
Portugal	Lar Júlio Alcântara Botelho	Elvas	Portalegre
Portugal	Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau	Funchal	Madeira
Portugal	Fundação João Bento Raimundo	Guarda
Portugal	Santa Casa da Misericórdia da Horta	Horta	Açores
Portugal	Centro Social Paroquial da Ilha - Obra Social da Sagrada Família	Leiria
Portugal	Associação Casapiana de Solidariedade	Lisboa
Portugal	Centro Comunitário e Paroquial da Ramada	Lisboa
Portugal	Centro Social Paroquial São Mamede	Lisboa
Portugal	Fundação AFID Diferença	Lisboa
Portugal	Santa Casa da Misericórdia da Lousã	Lousã	Coimbra
Portugal	Santa Casa da Misericórdia de Mértola	Mértola	Beja
Portugal	Santa Casa da Misericórdia de Mirandela	Mirandela	Bragança
Portugal	Santa Casa da Misericórdia de Montemor-o-Novo	Montemor-o-Novo	Évora
Portugal	Centro Social Paroquial de Oeiras	Oeiras	Lisboa
Portugal	Lar e Centro de Dia Padre Américo	Penafiel	Porto
Portugal	Associação dos Amigos de Peva	Peva	Guarda
Portugal	Santa Casa da Misericórdia de Ponte de Lima	Ponte de Lima	Viana Do Castelo
Portugal	Santa Casa da Misericórdia de Portimão	Portimão	Faro
Portugal	Associação de Solidariedade Social S. Tiago de Rebordões	Porto
Portugal	Centro Social Paroquial de Oliveira do Douro	Porto
Portugal	Centro Comunitário de São Brás	Praia Da Vitória	Açores
Portugal	Lar D. Pedro V	Praia Da Vitória	Açores
Portugal	Santa Casa da Misericórdia de Rio Maior	Rio Maior	Santarém
Portugal	Santa Casa da Misericórdia de Tarouca	Tarouca	Viseu
Portugal	Associação de Socorros da Freguesia de Turcifal	Torres Vedras	Lisboa
Portugal	Santa Casa da Misericórdia da Trofa	Trofa	Porto
Portugal	Casa de Repouso João Inácio de Sousa	Velas	Açores
Portugal	Centro Social e Cultural de Carreço	Viana Do Castelo
Portugal	Centro Social da Paróquia de Vieira do Minho	Vieira do Minho	Braga
Portugal	Santa Casa da Misericórdia de Vila do Porto	Vila do Porto	Açores
Portugal	Santa Casa da Misericórdia de Vila Nova de Cerveira	Vila Nova de Cerveira	Viana Do Castelo
Portugal	Centro Social Paroquial de Mateus	Vila Real
Portugal	Santa Casa da Misericórdia de Vila Velha de Rodão	Vila Velha de Rodão	Castelo Branco
Portugal	Santa Casa da Misericórdia de Vouzela	Vouzela	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
Rsocialform - Geriatria, Lda

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic information gathered through the sociodemographic questionnaire	The sociodemographic questionnaire was designed specifically for this study. It gathers information about the participants' gender, age, marital status, educational level, care and support services that the participant attends, medical comorbidities, including cognitive ones, and pharmacological treatment. It will be administered to all participants.	baseline
Other	Difficulties experienced by the older adult during the pandemic period gathered through the semi-structured interview	The semi-structured interview was designed specifically for this study. It will gather information about the participants' difficulties experienced during the pandemic period. It will only be administered to participants with a high MMSE score, according to their educational level, and with the language ability that ensures the comprehensibility of their interventions.	baseline
Primary	Cognitive functioning assessed through Mini-Mental State Examination (MMSE)	Cognitive functioning will be assessed using the MMSE, which is a gold standard for assessing global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	baseline
Primary	Executive functions assessed through Frontal Assessment Battery (FAB)	FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points. Higher scores indicate better cognitive function.	baseline
Primary	Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)	This instrument assesses depressive symptoms based on 20 statements classified on the frequency scale, with reference to the week prior to the assessment. Scores range between 0 and 60 points. Higher scores indicate more severe depressive symptoms.	baseline
Primary	Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)	GAI assesses, in several contexts, the severity of anxiety symptoms in older adults. It consists of 20 dichotomous response items (I agree/disagree) and refers to the subject's feelings in the week prior to the evaluation. One (1) point is assigned to each agree answer and the overall score is obtained by adding the scores of all items. Scores over 10/11 points indicate symptoms of severe anxiety.	baseline
Primary	Loneliness assessed through Loneliness Scale 3 Portuguese version (UCLA)	UCLA is composed of 20 items. Each item is answered according to a Likert scale from 1 (never) to 4 (always). Items 1, 5, 6, 9, 10, 15, 16, 19 and 20 are inverse-scored. Scores range from 20 to 80 points. Higher scores indicate a higher level of loneliness or perceived social isolation.	baseline
Primary	Quality of life assessed through Quality of Life - Alzheimer's Disease (QoL-AD)	The QoL-AD is used to assess quality of life. This 13-item scale assesses the quality of life in people diagnosed with dementia, gathering information from the patient about the following domains: perceived health, mood, physical condition, interpersonal relationships, hobbies, decision-making skills, and life as a whole. Scores range from 13 to 52, with higher scores indicating better quality of life.	baseline