Lung Function in Post-COVID-19 Nursing Home Residents

Completed

• Conditions: Post-COVID-19 Syndrome
• Interventions: Other: Previous exposure to SARS-CoV-2

• Registration Number: NCT05866211
• Lead Sponsor: University of Vic - Central University of Catalonia

Brief 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) \[modified Barthel index\].

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-25
• Primary Completion: 2022-11-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-19
• Study Completion: 2024-01-30
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Previous exposure to SARS-CoV-2	Individuals with impaired lung function, according to spirometry results (FVC ≤ LLN and FEV1/FVC ≥ LLN).
Control	Previous exposure to SARS-CoV-2	Individuals with normal lung function

Primary Outcome Measures

Name	Time	Method
Lung function	Through study completion, an average of 1 year	Lung function will be assessed by spirometry.

Secondary Outcome Measures

Name	Time	Method
COVID-19 variables	Through study completion, an average of 1 year	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).
Frailty	Through study completion, an average of 1 year	Frailty levels will be assessed using the Clinical Frailty Scale (CFS).
Dependency levels	Through study completion, an average of 1 year	Dependency levels will be assessed using the Barthel modified index.
Fatigue	Through study completion, an average of 1 year	Fatigue levels will be collected using the Chalder Fatigue Scale (CFQ-11)
Sociodemographic variables	Through study completion, an average of 1 year	Sociodemographic variables (age, gender, length of institutionalization) will be collected through an interview.
Health variables	Through study completion, an average of 1 year	Health variables (history of comorbidities) will be collected directly in the medical records of each participant.
Anthropometric variables	Through study completion, an average of 1 year	Anthropometric variables (weight and height) will be collected by means of a scale and a measuring tape, respectively.

Trial Locations

Locations (1)

Faculty of Health Sciences and Welfare; 🇪🇸 Vic, Barcelona, Spain