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临床试验/NCT05249868
NCT05249868已完成不适用

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)

Gerencia de Atención Primaria, Madrid2 个研究点 分布在 1 个国家目标入组 1,035 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,035
试验地点
2
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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).

结局指标

主要结局

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.

时间窗: up to 1 year

By analysing real-life data from electronic clinical records.

次要结局

  • 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 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)
  • Number of participants with changes caused by the SARS-CoV-2 pandemic in the mental health of non-institutionalised people aged 75 and over.(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.(zero time, baseline.)
  • 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)
  • Incidence of mortality caused by the SARS-CoV-2 pandemic among non-institutionalised persons aged 75 years and over.(18 months follow-up)

研究者

发起方
Gerencia de Atención Primaria, Madrid
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Milagros Rico Blazquez

Principal researcher

Gerencia de Atención Primaria, Madrid

研究点 (2)

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