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AgingCUIDAMOS+75NCT05249868

Impact of the COVID-19 Pandemic on the Health Status of People Aged 75 and Over and Their Caregivers

An observational study of Aging and SARS-CoV-2 Infection, run by Gerencia de Atención Primaria, Madrid at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The measures to control the transmissibility of the Covid-19 pandemic have changed the daily routines of the population, increasing sedentary lifestyles, decreasing outdoor physical activity and limiting contact with neighbors, family and friends. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Aging, SARS-CoV-2 Infection, Caregivers
What is being tested?
Exposure SARS-CoV-2 Infection
How many people
1,035 participants
Where
2 sitesSpain
Study dates
1 Jun 2022to 31 Jan 2025
How long will I take part?
18 Months
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Persons ≥75 years of age registered at the health centres in the study area. A total population of 1,619,620 users is estimated.

Who may be able to join

  • Have at least one entry in the electronic medical record during 2018 (Sub-study 1).
  • Have at least one entry in the clinical history during the last 6 months of 2019 (Sub-study 2).
  • Give informed consent (Sub-study 2 \& 3).
  • Family caregivers of dependent persons included in the population cohort (Sub-study 3).

Who cannot join

  • Not belonging to National Health System centres in the territorial demarcations participating in the study (Sub-study 1).
  • Not belonging to the quotas of the 105 participating nurses (Sub-study 2 \& 3).
  • Carers who have been caring for less than 6 months at the start of the pandemic, with sensory or cognitive deficits (Sub-study 3).

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Milagros Rico-Blazquez

    Madrid, Madrid, 28035

  • Milagros Rico-Blázquez

    Madrid, Madrid, 28035

Other trials in Spain

About this study

Official title: Multicentre Study on the Impact of the SARS-CoV-2 Pandemic on the Health Status of People Aged 75 and Over and Their Caregivers (CUIDAMOS+75 Project)

The measures to control the transmissibility of the Covid-19 pandemic have changed the daily routines of the population, increasing sedentary lifestyles, decreasing outdoor physical activity and limiting contact with neighbors, family and friends. This could be having negative consequences for the health of vulnerable people.

The investigators want to know how this situation has affected the health of people aged 75 years or older and their caregivers and how the circumstances experienced may mark new care needs.

Read more

To this end, will be analyzed clinical data, follow up people who have become ill with COVID-19 and those who have not, and interview groups of caregivers and patients to hear about the personal impact of the pandemic on them.

This will allow us to explore what changes are needed in health care to achieve an improvement in the health and quality of life of this population.

CUIDAMOS+75 seeks the commitment of the population and of the different people in charge of the health services from the very beginning.

Read the detailed description

Objective:

To explore the impact of the pandemic SARS-CoV-2 on the state of health of people aged ≥75 years.

Design:

Mixed-methods study. 1) Multipurpose, ambispective, longitudinal population-based cohort study with real world data and 6 years of follow-up; 2) Prospective observational cohort study with 18 months of follow-up; 3) Qualitative study with a critical-social approach. Scope:

Primary care in 11 Autonomous Regions.

Population:

People aged ≥75 years, attending healthcare centres in the study area.

Sample:

The population cohort will include the total population that meets the criteria, out of the estimated 1619620. The prospective cohort size is 1035, recruited on a probabilistic basis by clinical nurses. In the social critical approach the selection will be intentional and will progress towards theoretical sampling according to the emerging findings.

  1. outcome:

Population-based cohort: nursing diagnostic and interventions and use of services; mortality, quality of life (EQ-5D) and functional capacity (Barthel) for cohort follow-up.

  1. exposure:

SARS-CoV-2 infection.

Sources:

Clinical history, clinical interview, semi-structured interviews and focus groups.

Analysis:

Population cohort: to explore the evolution of diagnostic and interventions, a time series analysis will be carried out. Cohort study: Kaplan-Meier survival curves for mortality, functional change and quality of life. Cox proportional hazards models will be used to study the impact of infection on the three variables at 6, 12 and 18 months, adjusted for socio-demographic and clinical variables. Qualitative study: thematic, semiotic and discursive positions analysis.

Being tested
Exposure SARS-CoV-2 Infection
Keywords
Aging, SARS-CoV-2 infection, Caregivers, Primary Health Care, Nursing process, Standardized Nursing Terminology, Health Services Research, Cohort Studies, Qualitative Research, Real world data, quality of life
Medical subject headings
COVID-19, Frailty, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposure SARS-CoV-2 InfectionOther

    The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020.

    Positive confirmatory test on nucleic acid amplification (rRT-PCR) or having had symptoms for <5 days is positive on a PRAg test.

Study groups in NCT05249868
Study groupRoleWhat they receive
SARS-CoV-2 InfectionConfirmed SARS-CoV-2 infection diagnosed after 11 May 2020 and registered in electronic health records. (positive confirmatory test on nucleic acid amplification (rRT-PCR) or having had symptoms for <5 days is positive on a PRAg test)
Receives: Other: Exposure SARS-CoV-2 Infection
NO SARS-CoV-2 InfectionNo confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes caused by the SARS-CoV-2 pandemic in the use of health services in a population-based cohort of non-institutionalised people aged 75 years and older.

    By analysing real-life data from electronic clinical records.

    Measured: up to 1 year

Secondary outcomes (8)

  1. Changes from baseline prevalence of care needs of non-institutionalised people aged 75 and over in the context of the SARS-CoV-2 pandemic.

    Sub-study 1: Longitudinal study of a population-based, multipurpose, ambispective cohort. Variables on nursing interventions will be collected through the primary care electronic medical record.

    Measured: at the basal time.

  2. Changes from baseline prevalence of care needs of non-institutionalised people aged 75 and over in the context of the SARS-CoV-2 pandemic.

    Sub-study 1: Longitudinal study of a population-based, multipurpose, ambispective cohort. Variables on nursing interventions will be collected through the primary care electronic medical record.

    Measured: 6 years follow-up.

  3. Number of participants with changes caused by the SARS-CoV-2 pandemic in the functional capacity of non-institutionalised people aged 75 and over.

    Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change in functioning will be collected using the Barthel scale.

    Measured: 18 months follow-up

  4. Number of participants with changes caused by the SARS-CoV-2 pandemic in the quality of life of non-institutionalised people aged 75 and over.

    Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change quality of life will be collected using the EQ-5D.

    Measured: 18 months follow-up

  5. Number of participants with changes caused by the SARS-CoV-2 pandemic in the cognitive capacity of non-institutionalised people aged 75 years and over.

    Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change cognitive capacity will be collected using the Mini Mental Status Examination.

    Measured: 18 months follow-up

  6. Number of participants with changes caused by the SARS-CoV-2 pandemic in the mental health of non-institutionalised people aged 75 and over.

    Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on mental health capacity will be collected using the Hamilton Scale.

    Measured: 18 months follow-up

  7. Incidence of mortality caused by the SARS-CoV-2 pandemic among non-institutionalised persons aged 75 years and over.

    Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Mortality data shall be studied through medical records.

    Measured: 18 months follow-up

  8. Understand and interpret the social, political and economic dimensions linked to the use of health services by people aged 75 and over and family caregivers during the pandemic and think about possible coping strategies.

    Sub-study 3:Qualitative study with a social critical approach through semi-structured interviews for ≥75 years and focus groups for caregivers. A thematic analysis will be carried out, which will be complemented at the textual level by a semiotic analysis of discursive positions. In accordance with the critical character, discourse will be analysed as a reflection of ideological positions of inequality and domination.

    Measured: zero time, baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2022
  2. Study start1 Jun 2022
  3. Primary completion1 Dec 2024
  4. Study completion31 Jan 2025

Resources

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
Other
Enrolment
1,035 participants (actual)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05249868
Sponsor's protocol ID
20210009
Other IDs
PI21_00190, PI21_00648, PI21_CIII00015
Acronym
CUIDAMOS+75
Status last verified
Sep 2024
First submitted
8 Feb 2022
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mann DM, Chen J, Chunara R, Testa PA, Nov O. COVID-19 transforms health care through telemedicine: Evidence from the field. J Am Med Inform Assoc. 2020 Jul 1;27(7):1132-1135. doi: 10.1093/jamia/ocaa072.

    PubMed 32324855

  • Mowbray H. In Beijing, coronavirus 2019-nCoV has created a siege mentality. BMJ. 2020 Feb 7;368:m516. doi: 10.1136/bmj.m516. No abstract available.

    PubMed 32033967

  • Perez-Rodrigo C, Gianzo Citores M, Hervas Barbara G, Ruiz-Litago F, Casis Saenz L, Arija V, Lopez-Sobaler AM, Martinez de Victoria E, Ortega RM, Partearroyo T, Quiles-Izquierdo J, Ribas-Barba L, Rodriguez-Martin A, Salvador Castell G, Tur JA, Varela-Moreiras G, Serra-Majem L, Aranceta-Bartrina J. Patterns of Change in Dietary Habits and Physical Activity during Lockdown in Spain Due to the COVID-19 Pandemic. Nutrients. 2021 Jan 21;13(2):300. doi: 10.3390/nu13020300.

    PubMed 33494314

  • Roschel H, Artioli GG, Gualano B. Risk of Increased Physical Inactivity During COVID-19 Outbreak in Older People: A Call for Actions. J Am Geriatr Soc. 2020 Jun;68(6):1126-1128. doi: 10.1111/jgs.16550. Epub 2020 May 14. No abstract available.

    PubMed 32392620

  • Saltzman LY, Pat-Horenczyk R, Lombe M, Weltman A, Ziv Y, McNamara T, Takeuchi D, Brom D. Post-combat adaptation: improving social support and reaching constructive growth. Anxiety Stress Coping. 2018 Jul;31(4):418-430. doi: 10.1080/10615806.2018.1454740. Epub 2018 Apr 12.

    PubMed 29649912

  • Saltzman LY, Hansel TC, Bordnick PS. Loneliness, isolation, and social support factors in post-COVID-19 mental health. Psychol Trauma. 2020 Aug;12(S1):S55-S57. doi: 10.1037/tra0000703. Epub 2020 Jun 18.

    PubMed 32551762

  • Alfano V, Ercolano S. The Efficacy of Lockdown Against COVID-19: A Cross-Country Panel Analysis. Appl Health Econ Health Policy. 2020 Aug;18(4):509-517. doi: 10.1007/s40258-020-00596-3.

    PubMed 32495067

  • Borges-Machado F, Barros D, Ribeiro O, Carvalho J. The Effects of COVID-19 Home Confinement in Dementia Care: Physical and Cognitive Decline, Severe Neuropsychiatric Symptoms and Increased Caregiving Burden. Am J Alzheimers Dis Other Demen. 2020 Jan-Dec;35:1533317520976720. doi: 10.1177/1533317520976720.

    PubMed 33295781

  • Brown EE, Kumar S, Rajji TK, Pollock BG, Mulsant BH. Anticipating and Mitigating the Impact of the COVID-19 Pandemic on Alzheimer's Disease and Related Dementias. Am J Geriatr Psychiatry. 2020 Jul;28(7):712-721. doi: 10.1016/j.jagp.2020.04.010. Epub 2020 Apr 18.

    PubMed 32331845

  • Cohen G, Russo MJ, Campos JA, Allegri RF. Living with dementia: increased level of caregiver stress in times of COVID-19. Int Psychogeriatr. 2020 Nov;32(11):1377-1381. doi: 10.1017/S1041610220001593. Epub 2020 Jul 30.

    PubMed 32729446

  • Company-Sancho MC, Estupinan-Ramirez M, Sanchez-Janariz H, Tristancho-Ajamil R. The connection between nursing diagnosis and the use of healthcare resources. Enferm Clin. 2017 Jul-Aug;27(4):214-221. doi: 10.1016/j.enfcli.2017.04.002. Epub 2017 May 10. English, Spanish.

    PubMed 28501464

  • Dubey S, Biswas P, Ghosh R, Chatterjee S, Dubey MJ, Chatterjee S, Lahiri D, Lavie CJ. Psychosocial impact of COVID-19. Diabetes Metab Syndr. 2020 Sep-Oct;14(5):779-788. doi: 10.1016/j.dsx.2020.05.035. Epub 2020 May 27.

    PubMed 32526627

  • Freijomil-Vazquez C, Gastaldo D, Coronado C, Movilla-Fernandez MJ. When risk becomes illness: The personal and social consequences of cervical intraepithelial neoplasia medical surveillance. PLoS One. 2019 Dec 16;14(12):e0226261. doi: 10.1371/journal.pone.0226261. eCollection 2019.

    PubMed 31841543

  • Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352.

    PubMed 25910392

  • Johnson VR, Jacobson KL, Gazmararian JA, Blake SC. Does social support help limited-literacy patients with medication adherence? A mixed methods study of patients in the Pharmacy Intervention for Limited Literacy (PILL) study. Patient Educ Couns. 2010 Apr;79(1):14-24. doi: 10.1016/j.pec.2009.07.002. Epub 2009 Aug 3.

    PubMed 19647967

Questions about this trial

What is this clinical trial studying?

An observational study of Aging and SARS-CoV-2 Infection, run by Gerencia de Atención Primaria, Madrid at 2 sites in Spain.

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 4 inclusion and 3 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

Changes caused by the SARS-CoV-2 pandemic in the use of health services in a population-based cohort of non-institutionalised people aged 75 years and older. (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05249868, which also lists 18 linked publications.

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 3 Sep 2025.

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