- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05866211
Lung Function in Post-COVID-19 Nursing Home Residents
Associated Factors for Impaired Lung Function in Post-COVID Nursing Home Residents
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].
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona
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Vic, Barcelona, Spain, 08500
- Faculty of Health Sciences and Welfare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Case
Individuals with impaired lung function, according to spirometry results (FVC ≤ LLN and FEV1/FVC ≥ LLN).
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This is an observational study in which no intervention will be applied.
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Control
Individuals with normal lung function
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This is an observational study in which no intervention will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung function
Time Frame: Through study completion, an average of 1 year
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Lung function will be assessed by spirometry.
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sociodemographic variables
Time Frame: Through study completion, an average of 1 year
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Sociodemographic variables (age, gender, length of institutionalization) will be collected through an interview.
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Through study completion, an average of 1 year
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Anthropometric variables
Time Frame: Through study completion, an average of 1 year
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Anthropometric variables (weight and height) will be collected by means of a scale and a measuring tape, respectively.
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Through study completion, an average of 1 year
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Health variables
Time Frame: Through study completion, an average of 1 year
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Health variables (history of comorbidities) will be collected directly in the medical records of each participant.
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Through study completion, an average of 1 year
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COVID-19 variables
Time Frame: Through study completion, an average of 1 year
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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).
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Through study completion, an average of 1 year
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Fatigue
Time Frame: Through study completion, an average of 1 year
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Fatigue levels will be collected using the Chalder Fatigue Scale (CFQ-11)
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Through study completion, an average of 1 year
|
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Frailty
Time Frame: Through study completion, an average of 1 year
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Frailty levels will be assessed using the Clinical Frailty Scale (CFS).
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Through study completion, an average of 1 year
|
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Dependency levels
Time Frame: Through study completion, an average of 1 year
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Dependency levels will be assessed using the Barthel modified index.
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Through study completion, an average of 1 year
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUNGFUNCTIONCFCR101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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