Clinical trial NCT05249868: Impact of the COVID-19 Pandemic on the Health Status of People Aged 75 and Over and Their Caregivers
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aging
SARS-CoV-2 Infection
Caregivers
Frailty
Burden, Caregiver
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
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
name: Hospital del Mar Research Institute (IMIM)
name: Fundación para la Investigación e Innovación Biosanitaria de la Comunidad de Madrid
First posted: 2022-02-22
Enrollment: 1035
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

Brief 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. 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.

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.

Eligibility criteria: 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).

Primary outcomes:
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.
timeFrame: up to 1 year
Secondary outcomes:
measure: Changes from baseline prevalence of care needs of non-institutionalised people aged 75 and over in the context of the SARS-CoV-2 pandemic.
timeFrame: at the basal time.
measure: Changes from baseline prevalence of care needs of non-institutionalised people aged 75 and over in the context of the SARS-CoV-2 pandemic.
timeFrame: 6 years follow-up.
measure: Number of participants with changes caused by the SARS-CoV-2 pandemic in the functional capacity of non-institutionalised people aged 75 and over.
timeFrame: 18 months follow-up
measure: 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.
timeFrame: 18 months follow-up
measure: 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.
timeFrame: 18 months follow-up
measure: Number of participants with changes caused by the SARS-CoV-2 pandemic in the mental health of non-institutionalised people aged 75 and over.
timeFrame: 18 months follow-up
measure: Incidence of mortality caused by the SARS-CoV-2 pandemic among non-institutionalised persons aged 75 years and over.
timeFrame: 18 months follow-up
measure: 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.
timeFrame: zero time, baseline.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Milagros Rico-Blazquez
city: Madrid
country: Spain
facility: Milagros Rico-Blázquez
Study officials:
affiliation: Gerencia Asistencial de Atención Primaria de Madrid
name: Milagros Rico-Blázquez, Master
role: STUDY_DIRECTOR
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