Living With Long COVID: LONGCOVID-EXPERIENCE

November 3, 2023 updated by: Anna Selva, Corporacion Parc Tauli

Living With Long COVID: LONGCOVID-EXPERIENCE Qualitative Study

Background: One in ten people infected with COVID-19 presents persistent COVID, which consists of the presence of symptoms three months after the acute manifestations of COVID-19 and their persistence for at least two months, without being explained by an alternative diagnosis. The characteristics and clinical approach to persistent COVID syndrome are fairly well known, but not what the experience of people with persistent COVID is in relation to their daily life, their work life, and their experience with the healthcare received. Objective: to understand the experience of patients with persistent COVID in relation to the disease, the health care received and re-entry into the world of work

Methods: Qualitative, descriptive, phenomenological study, based on individual interviews. The study protocol will be registered in Clinicaltrials.gov. People with persistent COVID treated at the Parc Taulí Hospital will be included. Sampling will be by convenience, purposive and snowball and the sample size will be determined by data saturation. Semi-structured individual or group interviews will be conducted and the data will be analyzed following a reflective thematic analysis (Brawn and Clarke). The preliminary report will be triangulated with some participants and with the results obtained from a scoping review carried out by the research team.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pilar Peña, MD
  • Phone Number: 82054 +34937231010
  • Email: ppena@tauli.cat

Study Contact Backup

  • Name: Pilar Peña, MD
  • Phone Number: 82054 +34937231010

Study Locations

    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Corporació Sanitària Parc Taulí
        • Contact:
          • Pilar Peña, MD, MSci
          • Phone Number: 22313 937231010
          • Email: ppena@tauli.cat
        • Contact:
          • Anna Selva, MD, MPH, PhD
          • Phone Number: 22316 937231010
          • Email: aselva@tauli.cat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated at the Parc Taulí Hospital Universitari, a hospital with a reference population of 400,000 urban people and 4,500 workers.

Description

Inclusion Criteria:

  • women and men diagnosed with persistent COVID between March '20 to the present according to WHO criteria (persistent symptoms three months after the acute manifestations of COVID-19 and lasting at least two months and cannot be explained by an alternative diagnosis).
  • treated at the Parc Taulí Hospital
  • from 18 to 65 years

Exclusion Criteria:

-people who do not understand or can communicate in Catalan or Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Persons with- long-covid
Women and men diagnosed with persistent COVID according to WHO (World HEalth Organization) criteria: persistent symptoms three months after the acute manifestations of COVID-19 and lasting at least two months and cannot be explained by an alternative diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience of the disease
Time Frame: Up to three years
How is living with LongCOVID. Assessed through semi-structured interviews.
Up to three years
Experience with healthcare received
Time Frame: Up to three years
How is the experience of patients with the healthcare received for their condition. Assessed through semi-structured interviews.
Up to three years
Experience with return to work
Time Frame: Up to three years
What were the barriers and facilitators for returning to work after the disease. Assessed through semi-structures interviews.
Up to three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anna Selva, MD, MPH, PhD, Parc Taulí, Hospital Universitari- I3PT
  • Study Director: Juan Leiva, PhD, Universitat Autònoma Barcelona
  • Principal Investigator: Pilar Peña, MD, Parc Taulí, Hospital Universitari- I3PT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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