COVID-19, Patients' Evolution and the Influence of the Pandemic on Health Care and Outcomes in Chronic Diseases

NCT05168722 | Completed

• 1 other identifier: PI21/00824
• Study Type: observational
• Target: 2,220
• Locations: 1 country
• Sites: 5

Brief Summary

Objectives: 1.- To evaluate the changes in health care and use of services in patients with chronic diseases such as chronic obstructive pulmonary disease (COPD), heart failure and major depression between 2017-2019 and the years 2020-2022, COVID pandemic period, and to see their relationship with clinical outcomes (in terms of mortality, admissions, death, current situation of his disease) and changes in health-related quality of life. 2- To evaluate the health care provided to a cohort of patients diagnosed with SARSCOV-2 (COVID-19 positive) during 2020 based on accessibility, equity and outcomes obtained. 3-To evaluate the evolution of the cohort of patients diagnosed with SARSCOV-2 after two years of follow-up since their diagnosis and create clinical prediction rules for the persistence of symptoms. Methodology. Four cohorts already created in previous projects are included: three of chronic patients, COPD, heart failure, major depression, all of 2017, and for which baseline information is available for follow-up of the health care they received in the 2017-19 period compared to that received during the 2020-22 period and to see the changes in their health-related quality of life from baseline based on generic and specific questionnaires for each of the pathologies included. Another cohort of positive and admitted patients for COVID-19 in 2020 is included, in whom the services received will be evaluated and recorded symptoms persistency that may have had up to two years after their index admission to develop tools for predicting the persistence of symptoms in the medium-long term.

Conditions

COVID-19 Pandemic; Pulmonary Disease, Chronic Obstructive; Heart Failure, Congestive; Depressive Symptoms

Outcome Measures

Primary Outcomes (3)

• Death

  Death during follow up

  2 years

• Health services use

  Visits to primary care physician, specialist, outpatient care, emercengy room, hospital admissions

  2 years

• Patient reported outcome measurements changes

  Changes in generic and specific patient-reported outcome measure (PROMs) in the study period

  2 years

Interventions

No interventions OTHER

No interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Four cohorts already created in previous projects are included, three of chronic patients: 1-COPD, heart failure, major depression , all of 2017, and for which baseline information is available for follow-up of the health care they received in the 2017-19 period compared to that received during the 2020-22 Another cohort of positive and admitted patients for COVID-19 in 2020 is included

You may not qualify if:

• patients with pathologies organic or psychiatric that prevent collaboration in the study; illiterate or deficit patients sensory that prevent the completion of the outcome measurement instruments included in the study, or who refuse to participate

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead
• Instituto de Salud Carlos III: collaborator
• European Regional Development Fund: collaborator

Study Sites (5)

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, BIZKAIA, 48960, Spain

Location

Hospital U. Cruces

Barakaldo, Spain

Location

Hospital U. Basurto

Bilbao, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Location

MeSH Terms

Conditions

COVID-19; Pulmonary Disease, Chronic Obstructive; Heart Failure; Depression

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Jose M Quintana, PhD

  Hospital Galdakao-Usansolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Research Unit

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: December 23, 2021
• Study Start: February 28, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

ES (5)