- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05379426
Older Adults' Perceptions of the Impact COVID-19 Pandemic
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aveiro, Portugal, 3810-928
- Fundação Casa do Pessoal da Segurança Social e Saúde do Distrito de Aveiro
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Braga, Portugal
- Associação Grupo Desportivo e Social Penso Santo Estevão
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Braga, Portugal
- Centro Zulmira Pereira Simões
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Bragança, Portugal, 5300-127
- Obra Social Padre Miguel
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Castelo Branco, Portugal, 6000-773
- Santa Casa da Misericórdia de Castelo Branco
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Castelo Branco, Portugal, 6200-591
- Residência Sénior D. António
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Coimbra, Portugal, 3330-024
- Centro Social Rocha Barros
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Guarda, Portugal, 6300-659
- Fundação João Bento Raimundo
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Leiria, Portugal, 3105-108
- Centro Social Paroquial da Ilha - Obra Social da Sagrada Família
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Lisboa, Portugal, 1250-173
- Centro Social Paroquial São Mamede
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Lisboa, Portugal, 1500-661
- Associação Casapiana de Solidariedade
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Lisboa, Portugal, 2610-316
- Fundação AFID Diferença
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Lisboa, Portugal, 2675-791
- Centro Comunitário e Paroquial da Ramada
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Porto, Portugal, 4430-748
- Centro Social Paroquial de Oliveira do Douro
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Porto, Portugal
- Associação de Solidariedade Social S. Tiago de Rebordões
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Viana Do Castelo, Portugal, 4900-279
- Centro Social e Cultural de Carreço
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Vila Real, Portugal, 5000-266
- Centro Social Paroquial de Mateus
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Aveiro
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Albergaria-a-Velha, Aveiro, Portugal, 3850-096
- Santa Casa da Misericórdia de Albergaria-a-Velha
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Albergaria-a-Velha, Aveiro, Portugal, 3850-705
- CEDIARA - Associação de Solidariedade Social de Ribeira de Fráguas
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Açores
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Angra Do Heroísmo, Açores, Portugal, 9700-020
- Santa Casa da Misericórdia de Angra do Heroísmo
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Angra Do Heroísmo, Açores, Portugal, 9700-124
- Lar Recolhimento Jesus Maria José - Mónicas
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Calheta, Açores, Portugal, 9850-070
- Santa Casa da Misericórdia da Calheta
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Horta, Açores, Portugal, 9900-033
- Santa Casa da Misericórdia da Horta
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Praia Da Vitória, Açores, Portugal, 9760-438
- Lar D. Pedro V
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Praia Da Vitória, Açores, Portugal, 9760-664
- Centro Comunitário de São Brás
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Velas, Açores, Portugal, 9800-559
- Casa de Repouso João Inácio de Sousa
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Vila do Porto, Açores, Portugal, 9580-528
- Santa Casa da Misericórdia de Vila do Porto
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Beja
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Mértola, Beja, Portugal, 7750-295
- Santa Casa da Misericórdia de Mértola
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Braga
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Apúlia, Braga, Portugal, 4740-141
- ASCRA - Associação Social, Cultural e Recreativa de Apúlia
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Barcelos, Braga, Portugal, 4750-275
- Santa Casa da Misericórdia de Barcelos
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Vieira do Minho, Braga, Portugal, 4850-508
- Centro Social da Paróquia de Vieira do Minho
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Bragança
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Mirandela, Bragança, Portugal, 5370-491
- Santa Casa da Misericórdia de Mirandela
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Castelo Branco
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Vila Velha de Rodão, Castelo Branco, Portugal, 6030-230
- Santa Casa da Misericórdia de Vila Velha de Rodão
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Coimbra
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Lousã, Coimbra, Portugal, 3200-200
- Santa Casa da Misericórdia da Lousã
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Faro
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Portimão, Faro, Portugal, 8500-540
- Santa Casa da Misericórdia de Portimão
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Guarda
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Peva, Guarda, Portugal, 6350-331
- Associação dos Amigos de Peva
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Leiria
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Alcobaça, Leiria, Portugal, 2460-009
- Santa Casa da Misericórdia de Alcobaça
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Alvaiázere, Leiria, Portugal, 3250-115
- Santa Casa da Misericórdia de Alvaiázere
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Alvorge, Leiria, Portugal, 3240-407
- Santa Casa da Misericórdia de Alvorge
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Lisboa
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Alcabideche, Lisboa, Portugal, 2645-559
- Centro Social e Paroquial Alcabideche
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Alhandra, Lisboa, Portugal, 2600-488
- Associação do Hospital Civil e Misericórdia de Alhandra
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Carnide, Lisboa, Portugal, 1600-583
- APOIARTE - Associação de Apoio aos Artistas
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Oeiras, Lisboa, Portugal, 2780-020
- Centro Social Paroquial de Oeiras
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Torres Vedras, Lisboa, Portugal, 2565-785
- Associação de Socorros da Freguesia de Turcifal
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Madeira
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Funchal, Madeira, Portugal, 9000-040
- Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau
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Portalegre
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Arez, Portalegre, Portugal, 6050-201
- Santa Casa da Misericórdia de Arez
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Avis, Portalegre, Portugal, 7480-163
- Santa Casa da Misericórdia de Avis
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Elvas, Portalegre, Portugal, 7350-081
- Lar Júlio Alcântara Botelho
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Porto
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Penafiel, Porto, Portugal, 4560-389
- Lar e Centro de Dia Padre Américo
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Trofa, Porto, Portugal, 4785-289
- Santa Casa da Misericórdia da Trofa
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Santarém
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Rio Maior, Santarém, Portugal, 2040-333
- Santa Casa da Misericórdia de Rio Maior
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Viana Do Castelo
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Caminha, Viana Do Castelo, Portugal, 4910-106
- Santa Casa da Misericórdia de Caminha
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Ponte de Lima, Viana Do Castelo, Portugal, 4990-118
- Santa Casa da Misericórdia de Ponte de Lima
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Vila Nova de Cerveira, Viana Do Castelo, Portugal
- Santa Casa da Misericórdia de Vila Nova de Cerveira
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Viseu
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Abraveses, Viseu, Portugal, 3515-094
- A.S.S.F.A.
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Tarouca, Viseu, Portugal, 3610-143
- Santa Casa da Misericórdia de Tarouca
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Vouzela, Viseu, Portugal, 3670-257
- Santa Casa da Misericórdia de Vouzela
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Évora
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Montemor-o-Novo, Évora, Portugal
- Santa Casa da Misericórdia de Montemor-o-Novo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Screening tests and semi-structured interview
Battery of screening tests with semi-structured interview First, the Mini-Mental State Examination will be administered to participants to assess whether they meet the inclusion criteria and an identification code will be assigned to eligible participants.
Posteriorly, a clinical psychologist will administer the Frontal Assessment Battery, Center for Epidemiologic Studies Depression Scale, Geriatric Anxiety Inventory, Loneliness Scale 3 Portuguese version, Quality of Life - Alzheimer's Disease, and will conduct a semi-structured interview about the difficulties experienced by the older adult during the pandemic period.
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Battery of screening tests and the semi-structured interview focusing on the difficulties experienced by the older adult during the pandemic period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
Time Frame: baseline
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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.
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baseline
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Executive functions assessed through Frontal Assessment Battery (FAB)
Time Frame: baseline
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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.
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baseline
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Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: baseline
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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.
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baseline
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Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)
Time Frame: baseline
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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.
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baseline
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Loneliness assessed through Loneliness Scale 3 Portuguese version (UCLA)
Time Frame: baseline
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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.
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baseline
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Quality of life assessed through Quality of Life - Alzheimer's Disease (QoL-AD)
Time Frame: baseline
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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.
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baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sociodemographic information gathered through the sociodemographic questionnaire
Time Frame: baseline
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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.
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baseline
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Difficulties experienced by the older adult during the pandemic period gathered through the semi-structured interview
Time Frame: baseline
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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.
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susana I Justo Henriques, Ph.D., Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
- Principal Investigator: Elzbieta Bobrowicz Campos, Ph.D., Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
- Principal Investigator: João L Alves Apóstolo, Ph.D., Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13052022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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