Lung Function in Post-COVID-19 Nursing Home Residents

Post-COVID-19 Syndrome Clinical Trial

Official title:

Associated Factors for Impaired Lung Function in Post-COVID Nursing Home Residents

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05866211
• Other study ID #: LUNGFUNCTIONCFCR101
• Status: Enrolling by invitation
• 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
• 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).

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome

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