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

NCT05249868 | Completed

• 4 other identifiers: 20210009PI21_00190PI21_00648PI21_CIII00015
• Study Type: observational
• Target: 1,035
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

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.

  By analysing real-life data from electronic clinical records.

  up to 1 year

Secondary Outcomes (8)

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

  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.

  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.

  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.

  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.

  18 months follow-up

Study Arms (2)

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

NO SARS-CoV-2 Infection

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

Interventions

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.

SARS-CoV-2 Infection

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Instituto de Salud Carlos III: collaborator
• Hospital del Mar Research Institute (IMIM): collaborator
• Fundación para la Investigación e Innovación Biosanitaria de la Comunidad de Madrid: collaborator

Study Sites (2)

Milagros Rico-Blazquez

Madrid, Madrid, 28035, Spain

Location

Milagros Rico-Blázquez

Madrid, Madrid, 28035, Spain

Location

Related Publications (18)

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  PMID: 32551762 BACKGROUND

• Rico-Blazquez M, Esteban-Sepulveda S, Sanchez-Ruano R, Aritztegui-Echenique AM, Artigues-Barbera EM, Brito-Brito PR, Casado-Ramirez E, Cidoncha-Moreno MA, Fabregat-Julve MI, Feria-Raposo I, Hernandez-Pascual M, Lozano-Hernandez C, Moreno-Casbas MT, Otones-Reyes P, Palmar-Santos AM, Pedraz-Marcos A, Romero-Rodriguez EM, Sole-Agusti MC, Taltavull-Aparicio JM, Vidal-Thomas MC, Gonzalez-Chorda VM; Cuidamos+75 Group. Impact of the COVID-19 pandemic on the self-care and health condition of the older adults. CUIDAMOS+75. A mixed methods study protocol. Front Public Health. 2024 Jun 17;12:1389641. doi: 10.3389/fpubh.2024.1389641. eCollection 2024.

  PMID: 38952731 DERIVED

MeSH Terms

Conditions

COVID-19; Frailty; Caregiver Burden

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Milagros Rico-Blázquez, Master

  Gerencia Asistencial de Atención Primaria de Madrid

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 18 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal researcher

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 22, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 31, 2025
• Last Updated: September 3, 2025

Record last verified: 2024-09

Locations

ES (2)