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

NCT05736822 | Completed

• 1 other identifier: 15813
• Study Type: observational
• Target: 5,277
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedures, Operative; COVID-19; SARS-CoV-2

Keywords

Specialties, Surgical; Surgery Department, Hospital

Outcome Measures

Primary Outcomes (1)

• Patient Reported Experience Measures

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

  2020-2021

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(former) surgical, orthopedic, cardiological patients

You may qualify if:

• undergoing surgery or intervention in the Netherlands in 2020 or 2021

You may not qualify if:

• participation language restricted to Dutch

Sponsors & Collaborators

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

Study Sites (1)

UMCG

Groningen, Netherlands

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 21, 2023
• Study Start: November 1, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 25, 2024
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: from 01-01-2027 until 30-04-2039
• Access Criteria: The anonymised dataset is available upon request to the principal investigator Prof. Schelto Kruijff. Requests can be send by email and should include a description of the study objective, primary and secondary outcomes, other data sources that will be used (if applicable), and a brief analysis plan. After discussion within the COVID Surg III research collective, the PI will decide whether or not the dataset will be shared with the requesting researcher. After a positive decision a data sharing agreement will be drafted and signed before the data is shared via a secured digital pathway, for example Zivver.

Locations

NL (1)