COVID-19 PandemicNCT05379426
Older Adults' Perceptions of the Impact COVID-19 Pandemic
An observational study of COVID-19 Pandemic and Depression, Anxiety, run by Rsocialform - Geriatria, Lda at 58 sites in Portugal.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COVID-19 Pandemic, Depression, Anxiety, Cognitive Impairment
- What is being tested?
- Impact COVID-19 pandemic
- How many people
- 880 participants
- Where
- 58 sitesPortugal
- Study dates
- 1 Jun 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
Portugal58 sites
A.S.S.F.A.
Abraveses, Viseu District, 3515-094
Santa Casa da Misericórdia de Albergaria-a-Velha
Albergaria-a-Velha, Aveiro District, 3850-096
Cediara - Associação de Solidariedade Social de Ribeira de Fráguas
Albergaria-a-Velha, Aveiro District, 3850-705
Centro Social e Paroquial Alcabideche
Alcabideche, Lisbon District, 2645-559
Santa Casa da Misericórdia de Alcobaça
Alcobaça, Leiria District, 2460-009
Associação do Hospital Civil e Misericórdia de Alhandra
Alhandra, Lisbon District, 2600-488
Santa Casa da Misericórdia de Alvaiázere
Alvaiázere, Leiria District, 3250-115
Santa Casa da Misericórdia de Alvorge
Alvorge, Leiria District, 3240-407
Santa Casa da Misericórdia de Angra do Heroísmo
Angra do Heroísmo, Azores, 9700-020
Lar Recolhimento Jesus Maria José - Mónicas
Angra do Heroísmo, Azores, 9700-124
ASCRA - Associação Social, Cultural e Recreativa de Apúlia
Apúlia, Braga District, 4740-141
Santa Casa da Misericórdia de Arez
Arez, Portalegre District, 6050-201
Fundação Casa do Pessoal da Segurança Social e Saúde do Distrito de Aveiro
Aveiro, 3810-928
Santa Casa da Misericórdia de Avis
Avis, Portalegre District, 7480-163
Santa Casa da Misericórdia de Barcelos
Barcelos, Braga District, 4750-275
Associação Grupo Desportivo e Social Penso Santo Estevão
Braga
Centro Zulmira Pereira Simões
Braga
Obra Social Padre Miguel
Bragança, 5300-127
Santa Casa da Misericórdia da Calheta
Calheta, Azores, 9850-070
Santa Casa da Misericórdia de Caminha
Caminha, Viana do Castelo District, 4910-106
APOIARTE - Associação de Apoio aos Artistas
Carnide, Lisbon District, 1600-583
Santa Casa da Misericórdia de Castelo Branco
Castelo Branco, 6000-773
Residência Sénior D. António
Castelo Branco, 6200-591
Centro Social Rocha Barros
Coimbra, 3330-024
Lar Júlio Alcântara Botelho
Elvas, Portalegre District, 7350-081
Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau
Funchal, Madeira, 9000-040
Fundação João Bento Raimundo
Guarda, 6300-659
Santa Casa da Misericórdia da Horta
Horta, Azores, 9900-033
Centro Social Paroquial da Ilha - Obra Social da Sagrada Família
Leiria, 3105-108
Centro Social Paroquial São Mamede
Lisbon, 1250-173
Associação Casapiana de Solidariedade
Lisbon, 1500-661
Fundação AFID Diferença
Lisbon, 2610-316
Centro Comunitário e Paroquial da Ramada
Lisbon, 2675-791
Santa Casa da Misericórdia da Lousã
Lousã, Coimbra District, 3200-200
Santa Casa da Misericórdia de Mértola
Mértola, Beja District, 7750-295
Santa Casa da Misericórdia de Mirandela
Mirandela, Braganza District, 5370-491
Santa Casa da Misericórdia de Montemor-o-Novo
Montemor-o-Novo, Évora District
Centro Social Paroquial de Oeiras
Oeiras, Lisbon District, 2780-020
Lar e Centro de Dia Padre Américo
Penafiel, Porto District, 4560-389
Associação dos Amigos de Peva
Peva, Guarda District, 6350-331
Santa Casa da Misericórdia de Ponte de Lima
Ponte de Lima, Viana do Castelo District, 4990-118
Santa Casa da Misericórdia de Portimão
Portimão, Faro District, 8500-540
Centro Social Paroquial de Oliveira do Douro
Porto, 4430-748
Associação de Solidariedade Social S. Tiago de Rebordões
Porto
Lar D. Pedro V
Praia da Vitória, Azores, 9760-438
Centro Comunitário de São Brás
Praia da Vitória, Azores, 9760-664
Santa Casa da Misericórdia de Rio Maior
Rio Maior, Santarém District, 2040-333
Santa Casa da Misericórdia de Tarouca
Tarouca, Viseu District, 3610-143
Associação de Socorros da Freguesia de Turcifal
Torres Vedras, Lisbon District, 2565-785
Santa Casa da Misericórdia da Trofa
Trofa, Porto District, 4785-289
Casa de Repouso João Inácio de Sousa
Velas, Azores, 9800-559
Centro Social e Cultural de Carreço
Viana do Castelo, 4900-279
Centro Social da Paróquia de Vieira do Minho
Vieira do Minho, Braga District, 4850-508
Santa Casa da Misericórdia de Vila do Porto
Vila do Porto, Azores, 9580-528
Santa Casa da Misericórdia de Vila Nova de Cerveira
Vila Nova de Cerveira, Viana do Castelo District
Centro Social Paroquial de Mateus
Vila Real, 5000-266
Santa Casa da Misericórdia de Vila Velha de Rodão
Vila Velha de Rodão, Castelo Branco District, 6030-230
Santa Casa da Misericórdia de Vouzela
Vouzela, Viseu District, 3670-257
About this study
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
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.
Read the 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.
- Being tested
- Impact COVID-19 pandemic
- Keywords
- older adults, COVID-19, cognitive function, executive function, mood, depression, anxiety, loneliness, quality of life
- Medical subject headings
- COVID-19, Depression, Anxiety Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact COVID-19 pandemicOther
Battery of screening tests and the semi-structured interview focusing on the difficulties experienced by the older adult during the pandemic period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Impact COVID-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jun 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rsocialform - Geriatria, Lda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana I Justo Henriques, Ph.D., Principal investigator, Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of CoimbraElzbieta Bobrowicz Campos, Ph.D., Principal investigator, Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of CoimbraJoão L Alves Apóstolo, Ph.D., Principal investigator, Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379426
- Sponsor's protocol ID
- 13052022
- Status last verified
- Jul 2022
- First submitted
- 17 May 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05379426
- Acronym / sponsor ID
- 13052022
- Keywords
- older adults, COVID-19, cognitive function, executive function, mood, depression, anxiety, loneliness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- Rsocialform - Geriatria, LdaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening tests and semi-structured interview | – | Other: Impact COVID-19 pandemicBattery 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact COVID-19 pandemicBattery of screening tests and the semi-structured interview focusing on the difficulties experienced by the older adult during the pandemic period. | Other | Screening tests and semi-structured interview |
Primary outcome
Cognitive functioning assessed through Mini-Mental State Examination (MMSE)
Time frame: baseline
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.
Executive functions assessed through Frontal Assessment Battery (FAB)
Time frame: baseline
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.
Depressive symptomatology assessed through the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: baseline
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.
Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)
Time frame: baseline
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.
Loneliness assessed through Loneliness Scale 3 Portuguese version (UCLA)
Time frame: baseline
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.
Quality of life assessed through Quality of Life - Alzheimer's Disease (QoL-AD)
Time frame: baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana I Justo Henriques, Ph.D. principal investigator
Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
Elzbieta Bobrowicz Campos, Ph.D. principal investigator
Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
João L Alves Apóstolo, Ph.D. principal investigator
Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic and Depression, Anxiety, run by Rsocialform - Geriatria, Lda at 58 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functioning assessed through Mini-Mental State Examination (MMSE) (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.