Clincosm LogoSign in Get a demo

COVID Surg III: The Impact of the Covid Pandemic on the Patient in Need of an Intervention

Sponsor
University Medical Center Groningen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05736822
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
10,000
Enrollment
5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Mixed-method observational study: the impact of pandemic related changes in healthcare on quality of life and experiences with healthcare in Dutch patients undergoing surgery or another intervention during the covid pandemic (2020-2021).

Phase 1: qualitative study to gain insight in relevant themes in Patient Reported Experiences Measures (PREMs) by conducting focus groups Phase 2: creating and validating a questionnaire based on themes identified in phase 1 Phase 3: questionnaire study among Dutch patients who underwent an intervention in 2020-2021 using the validated questionnaire of phase 2. The answers will be linked to data from national patients registries in surgery, cardiology, orthopedics and neurology.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Impact of the Covid Pandemic on the Patient in Need of an Intervention - COVID Surg III
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Patient Reported Experience Measures [2020-2021]

      [will be specified based on phase 1 of the study, see description]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • undergoing surgery or intervention in the Netherlands in 2020 or 2021
    Exclusion Criteria:
    • participation language restricted to Dutch

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Medical Center Groningen
    • ZonMw: The Netherlands Organisation for Health Research and Development

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT05736822
    Other Study ID Numbers:
    • 15813
    First Posted:
    Feb 21, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 21, 2023