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

Gerencia de Atención Primaria, Madrid1,035 enrolled

Overview

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.

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

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: up to 1 year

Secondary Outcomes

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.

Time frame: 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.

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.

Time frame: 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.

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.