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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05866211
Other study ID # LUNGFUNCTIONCFCR101
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 25, 2022
Est. completion date January 30, 2024

Study information

Verified date May 2023
Source University of Vic - Central University of Catalonia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The coronavirus disease 2019 (COVID-19) took a toll in institutionalised older adults, who represent a vulnerable population in European countries. The aim of this study is to identify the predictive factors that worsens lung function in post-COVID nursing home (NH) residents. This is a multicenter case-control study in nursing homes of Osona (Catalonia), where individuals with worsened (cases) and normal (controls) lung function will be studied. The inclusion criteria are: female and male from 65 to 95 years old, preserved cognitive capacity and positive diagnosis of COVID-19 at least 3 months prior. We will assess sociodemographic variables, lung function [spirometry], fatigue [Chalder Fatigue Scale], frailty [Clinical Frailty Scale], and activities of daily living (ADL) [modified Barthel index].


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date January 30, 2024
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years to 95 Years
Eligibility Inclusion Criteria: - male and female - preserved cognitive function - previous positive diagnosis of COVID-19 at a minimum of 3 months to the day of data collection - individuals living permanently in a nursing home Exclusion Criteria: - individuals in coma or palliative care - any contraindication to perform spirometry (severe hypertension, myocardial infarction in the past week, non compensated heart failure, etc).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Previous exposure to SARS-CoV-2
This is an observational study in which no intervention will be applied.

Locations

Country Name City State
Spain Faculty of Health Sciences and Welfare Vic Barcelona

Sponsors (2)

Lead Sponsor Collaborator
University of Vic - Central University of Catalonia Catalan Board of Physiotherapists

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lung function Lung function will be assessed by spirometry. Through study completion, an average of 1 year
Secondary Sociodemographic variables Sociodemographic variables (age, gender, length of institutionalization) will be collected through an interview. Through study completion, an average of 1 year
Secondary Anthropometric variables Anthropometric variables (weight and height) will be collected by means of a scale and a measuring tape, respectively. Through study completion, an average of 1 year
Secondary Health variables Health variables (history of comorbidities) will be collected directly in the medical records of each participant. Through study completion, an average of 1 year
Secondary COVID-19 variables The following variables related to COVID-19 will be collected from the medical records of each participant: diagnostic tests (PCR and serological test), suspicious case (symptoms of cough, fever, difficulty breathing, etc.), previous hospitalization for COVID-19 (yes/no, duration), use of mechanical ventilation during hospitalization (yes/no, duration) and vaccination (yes/no, type). Through study completion, an average of 1 year
Secondary Fatigue Fatigue levels will be collected using the Chalder Fatigue Scale (CFQ-11) Through study completion, an average of 1 year
Secondary Frailty Frailty levels will be assessed using the Clinical Frailty Scale (CFS). Through study completion, an average of 1 year
Secondary Dependency levels Dependency levels will be assessed using the Barthel modified index. Through study completion, an average of 1 year
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