NCT05379426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

58 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

May 17, 2022

Last Update Submit

July 31, 2022

Conditions

Keywords

older adultsCOVID-19cognitive functionexecutive functionmooddepressionanxietylonelinessquality of life

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Other Outcomes (2)

  • Sociodemographic information gathered through the sociodemographic questionnaire

    baseline

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

    baseline

Study Arms (1)

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.

Other: Impact COVID-19 pandemic

Interventions

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

Screening tests and semi-structured interview

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (58)

Santa Casa da Misericórdia de Albergaria-a-Velha

Albergaria-a-Velha, Aveiro District, 3850-096, Portugal

Location

Cediara - Associação de Solidariedade Social de Ribeira de Fráguas

Albergaria-a-Velha, Aveiro District, 3850-705, Portugal

Location

Santa Casa da Misericórdia de Angra do Heroísmo

Angra do Heroísmo, Azores, 9700-020, Portugal

Location

Lar Recolhimento Jesus Maria José - Mónicas

Angra do Heroísmo, Azores, 9700-124, Portugal

Location

Santa Casa da Misericórdia da Calheta

Calheta, Azores, 9850-070, Portugal

Location

Santa Casa da Misericórdia da Horta

Horta, Azores, 9900-033, Portugal

Location

Lar D. Pedro V

Praia da Vitória, Azores, 9760-438, Portugal

Location

Centro Comunitário de São Brás

Praia da Vitória, Azores, 9760-664, Portugal

Location

Casa de Repouso João Inácio de Sousa

Velas, Azores, 9800-559, Portugal

Location

Santa Casa da Misericórdia de Vila do Porto

Vila do Porto, Azores, 9580-528, Portugal

Location

Santa Casa da Misericórdia de Mértola

Mértola, Beja District, 7750-295, Portugal

Location

ASCRA - Associação Social, Cultural e Recreativa de Apúlia

Apúlia, Braga District, 4740-141, Portugal

Location

Santa Casa da Misericórdia de Barcelos

Barcelos, Braga District, 4750-275, Portugal

Location

Centro Social da Paróquia de Vieira do Minho

Vieira do Minho, Braga District, 4850-508, Portugal

Location

Santa Casa da Misericórdia de Mirandela

Mirandela, Braganza District, 5370-491, Portugal

Location

Santa Casa da Misericórdia de Vila Velha de Rodão

Vila Velha de Rodão, Castelo Branco District, 6030-230, Portugal

Location

Santa Casa da Misericórdia da Lousã

Lousã, Coimbra District, 3200-200, Portugal

Location

Santa Casa da Misericórdia de Portimão

Portimão, Faro District, 8500-540, Portugal

Location

Associação dos Amigos de Peva

Peva, Guarda District, 6350-331, Portugal

Location

Santa Casa da Misericórdia de Alcobaça

Alcobaça, Leiria District, 2460-009, Portugal

Location

Santa Casa da Misericórdia de Alvaiázere

Alvaiázere, Leiria District, 3250-115, Portugal

Location

Santa Casa da Misericórdia de Alvorge

Alvorge, Leiria District, 3240-407, Portugal

Location

Centro Social e Paroquial Alcabideche

Alcabideche, Lisbon District, 2645-559, Portugal

Location

Associação do Hospital Civil e Misericórdia de Alhandra

Alhandra, Lisbon District, 2600-488, Portugal

Location

APOIARTE - Associação de Apoio aos Artistas

Carnide, Lisbon District, 1600-583, Portugal

Location

Centro Social Paroquial de Oeiras

Oeiras, Lisbon District, 2780-020, Portugal

Location

Associação de Socorros da Freguesia de Turcifal

Torres Vedras, Lisbon District, 2565-785, Portugal

Location

Associação de Desenvolvimento Comunitário do Funchal - Garouta do Calhau

Funchal, Madeira, 9000-040, Portugal

Location

Santa Casa da Misericórdia de Arez

Arez, Portalegre District, 6050-201, Portugal

Location

Santa Casa da Misericórdia de Avis

Avis, Portalegre District, 7480-163, Portugal

Location

Lar Júlio Alcântara Botelho

Elvas, Portalegre District, 7350-081, Portugal

Location

Lar e Centro de Dia Padre Américo

Penafiel, Porto District, 4560-389, Portugal

Location

Santa Casa da Misericórdia da Trofa

Trofa, Porto District, 4785-289, Portugal

Location

Santa Casa da Misericórdia de Rio Maior

Rio Maior, Santarém District, 2040-333, Portugal

Location

Santa Casa da Misericórdia de Caminha

Caminha, Viana do Castelo District, 4910-106, Portugal

Location

Santa Casa da Misericórdia de Ponte de Lima

Ponte de Lima, Viana do Castelo District, 4990-118, Portugal

Location

Santa Casa da Misericórdia de Vila Nova de Cerveira

Vila Nova de Cerveira, Viana do Castelo District, Portugal

Location

A.S.S.F.A.

Abraveses, Viseu District, 3515-094, Portugal

Location

Santa Casa da Misericórdia de Tarouca

Tarouca, Viseu District, 3610-143, Portugal

Location

Santa Casa da Misericórdia de Vouzela

Vouzela, Viseu District, 3670-257, Portugal

Location

Fundação Casa do Pessoal da Segurança Social e Saúde do Distrito de Aveiro

Aveiro, 3810-928, Portugal

Location

Associação Grupo Desportivo e Social Penso Santo Estevão

Braga, Portugal

Location

Centro Zulmira Pereira Simões

Braga, Portugal

Location

Obra Social Padre Miguel

Bragança, 5300-127, Portugal

Location

Santa Casa da Misericórdia de Castelo Branco

Castelo Branco, 6000-773, Portugal

Location

Residência Sénior D. António

Castelo Branco, 6200-591, Portugal

Location

Centro Social Rocha Barros

Coimbra, 3330-024, Portugal

Location

Fundação João Bento Raimundo

Guarda, 6300-659, Portugal

Location

Centro Social Paroquial da Ilha - Obra Social da Sagrada Família

Leiria, 3105-108, Portugal

Location

Centro Social Paroquial São Mamede

Lisbon, 1250-173, Portugal

Location

Associação Casapiana de Solidariedade

Lisbon, 1500-661, Portugal

Location

Fundação AFID Diferença

Lisbon, 2610-316, Portugal

Location

Centro Comunitário e Paroquial da Ramada

Lisbon, 2675-791, Portugal

Location

Centro Social Paroquial de Oliveira do Douro

Porto, 4430-748, Portugal

Location

Associação de Solidariedade Social S. Tiago de Rebordões

Porto, Portugal

Location

Centro Social e Cultural de Carreço

Viana do Castelo, 4900-279, Portugal

Location

Centro Social Paroquial de Mateus

Vila Real, 5000-266, Portugal

Location

Santa Casa da Misericórdia de Montemor-o-Novo

Montemor-o-Novo, Évora District, Portugal

Location

MeSH Terms

Conditions

COVID-19DepressionAnxiety DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehaviorMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 18, 2022

Study Start

June 1, 2022

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations