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NCT Number: NCT05249868

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

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.

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.

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Key information

Conditions

Aging Behavior Behavioral Symptoms Burden, Caregiver COVID-19 Caregiver Burden Caregivers Coronaviridae Infections Coronavirus Infections Frailty Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Stress, Psychological Virus Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Milagros Rico-Blazquez, Madrid, Spain

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About this study

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.

V. 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.

V. 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

Exposure SARS-CoV-2 Infection

Other

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.

Primary outcomes

  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.

    Time frame: up to 1 year

    By analysing real-life data from electronic clinical records.

Secondary outcomes

  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.

    Time frame: at the basal time.

    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.

  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.

    Time frame: 6 years follow-up.

    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.

  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.

    Time frame: 18 months follow-up

    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.

  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.

    Time frame: 18 months follow-up

    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.

  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.

    Time frame: 18 months follow-up

    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.

  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.

    Time frame: 18 months follow-up

    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.

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

    Time frame: 18 months follow-up

    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.

  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.

    Time frame: zero time, baseline.

    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.

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

  • Fundación para la Investigación e Innovación Biosanitaria de la Comunidad de Madrid
  • Hospital del Mar Research Institute (IMIM)
  • Instituto de Salud Carlos III

Registry information

Official study 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)

Acronym: CUIDAMOS+75

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 22, 2022
Registry last updated
Sep 3, 2025

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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