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Completed

NCT Number: NCT05379426

Older Adults' Perceptions of the Impact COVID-19 Pandemic

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cediara - Associação de Solidariedade Social de Ribeira de Fráguas, Albergaria-a-Velha, Aveiro District, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Impact COVID-19 pandemic

Other

Battery of screening tests and the semi-structured interview focusing on the difficulties experienced by the older adult during the pandemic period.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. Sociodemographic information gathered through the sociodemographic questionnaire

    Time frame: baseline

    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.

  2. Difficulties experienced by the older adult during the pandemic period gathered through the semi-structured interview

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Rsocialform - Geriatria, Lda

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 18, 2022
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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