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Living With Long COVID: LONGCOVID-EXPERIENCE

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Recruiting
CT.gov ID
NCT06118112
Collaborator
Universitat Autonoma de Barcelona (Other)
25
Enrollment
1
Location
15.4
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    25 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Living With Long COVID: LONGCOVID-EXPERIENCE Qualitative Study
    Actual Study Start Date :
    Sep 18, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2024
    Anticipated Study Completion Date :
    Dec 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Experience of the disease [Up to three years]

      How is living with LongCOVID. Assessed through semi-structured interviews.

    2. Experience with healthcare received [Up to three years]

      How is the experience of patients with the healthcare received for their condition. Assessed through semi-structured interviews.

    3. Experience with return to work [Up to three years]

      What were the barriers and facilitators for returning to work after the disease. Assessed through semi-structures interviews.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Corporació Sanitària Parc Taulí Sabadell Barcelona Spain 08208

    Sponsors and Collaborators

    • Corporacion Parc Tauli
    • Universitat Autonoma de Barcelona

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna Selva, Co-principal investigator, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT06118112
    Other Study ID Numbers:
    • LONGCOVID EXPERIENCE
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 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
    Keywords provided by Anna Selva, Co-principal investigator, Corporacion Parc Tauli
    Post-Acute COVID-19 Syndrome
    patient experience
    qualitative research
    Additional relevant MeSH terms:
    Post-Acute COVID-19 Syndrome

    Study Results

    No Results Posted as of Nov 7, 2023