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NCT05736822 Clinical Trial

The Impact of the COVID-19 Pandemic on the Patient in Need of an Intervention

COVID-19 Clinical Trial

— COVID Surg III  

Official title:
The Impact of the COVID-19 Pandemic on the Patient in Need of an Intervention - COVID Surg III

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05736822
Other study ID # 15813
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date March 2024

Study information
Verified date January 2024
Source University Medical Center Groningen
Contact Schelto Kruijff, prof
Phone +3150 361 85 00
Email s.kruijff@umcg.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - undergoing surgery or intervention in the Netherlands in 2020 or 2021 Exclusion Criteria: - participation language restricted to Dutch

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands UMCG Groningen

Sponsors (2)
Lead Sponsor Collaborator
University Medical Center Groningen ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Reported Experience Measures [will be specified based on phase 1 of the study, see description] 2020-2021
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