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

September 13, 2023 updated by: Milagros Rico Blazquez, Gerencia de Atención Primaria, Madrid

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Observational

Enrollment (Estimated)

1035

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28035
        • Milagros Rico-Blázquez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SARS-CoV-2 Infection

Confirmed 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)
Other: Exposure SARS-CoV-2 Infection

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.
NO SARS-CoV-2 Infection
No confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the basal time.
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.
6 years follow-up.
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.
18 months follow-up
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.
18 months follow-up
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.
18 months follow-up
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.
18 months follow-up
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.
18 months follow-up
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.
zero time, baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerencia de Atención Primaria, Madrid

Collaborators

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

Investigators

  • Study Director: Milagros Rico-Blázquez, Master, Gerencia Asistencial de Atención Primaria de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210009
  • PI21_00190 (Other Grant/Funding Number: Instituto de Salud Carlos III and ERDF)
  • PI21_00648 (Other Grant/Funding Number: Instituto de Salud Carlos III and ERDF)
  • PI21_CIII00015 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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