Lung Function in Post-COVID-19 Nursing Home Residents

Sponsor
University of Vic - Central University of Catalonia (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05866211
Collaborator
Catalan Board of Physiotherapists (Other)
150
1
21.2
7.1

Study Details

Study Description

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].

Condition or Disease Intervention/Treatment Phase
  • Other: Previous exposure to SARS-CoV-2

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Associated Factors for Impaired Lung Function in Post-COVID Nursing Home Residents
Actual Study Start Date :
Apr 25, 2022
Actual Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Case

Individuals with impaired lung function, according to spirometry results (FVC ≤ LLN and FEV1/FVC ≥ LLN).

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

Control

Individuals with normal lung function

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

Outcome Measures

Primary Outcome Measures

  1. Lung function [Through study completion, an average of 1 year]

    Lung function will be assessed by spirometry.

Secondary Outcome Measures

  1. Sociodemographic variables [Through study completion, an average of 1 year]

    Sociodemographic variables (age, gender, length of institutionalization) will be collected through an interview.

  2. 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.

  3. 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.

  4. 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).

  5. Fatigue [Through study completion, an average of 1 year]

    Fatigue levels will be collected using the Chalder Fatigue Scale (CFQ-11)

  6. Frailty [Through study completion, an average of 1 year]

    Frailty levels will be assessed using the Clinical Frailty Scale (CFS).

  7. Dependency levels [Through study completion, an average of 1 year]

    Dependency levels will be assessed using the Barthel modified index.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Health Sciences and Welfare Vic Barcelona Spain 08500

Sponsors and Collaborators

  • University of Vic - Central University of Catalonia
  • Catalan Board of Physiotherapists

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Vic - Central University of Catalonia
ClinicalTrials.gov Identifier:
NCT05866211
Other Study ID Numbers:
  • LUNGFUNCTIONCFCR101
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2023