Investigation on the Hesitancy of COVID-19 Vaccination Among Liver Transplant Recipients in China

September 7, 2022 updated by: Yongbing Qian, RenJi Hospital
On WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Patients meeting inclusion and exclusion criteria will be selected. Conduct statistical analysis to describe the incidence of adverse reactions related to COVID-19 vaccine after liver transplantation, and to compare and evaluate the factors leading to COVID-19 vaccine hesitancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

On WeChat platform, through a point-to-point connection, and carry on the questionnaire survey to collect information of liver transplant recipients followed-up by the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University. Questionnaire items including demographic characteristics, understanding of COVID-19, attitude toward COVID-19 vaccine. Patients meeting inclusion and exclusion criteria will be selected. Conduct statistical analysis to describe the incidence of adverse reactions related to COVID-19 vaccine after liver transplantation, and to compare and evaluate the factors leading to COVID-19 vaccine hesitancy.

Study Type

Observational

Enrollment (Actual)

449

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects of this study were adult recipients who were followed up after liver transplantation in the department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.

Description

Inclusion Criteria:

  1. age ≥ 18
  2. recipients after liver transplantation surgery

Exclusion Criteria:

  1. Incomplete data (missing questionnaire information), such as lack of age, gender, indication for transplantation, time after transplantation and other indicators
  2. loss to follow-up
  3. COVID-19 vaccination before liver transplantation

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no hesitancy group (NHG)
Participants who got vaccine after transplantation or were willing to be vaccinated.
Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccine
Attitude towards COVID-19; Knowledge about COVID-19 vaccine
hesitancy group (HG)
Participants who were uncertain or refused to be vaccinated.
Other: Perceptions and attitudes towards COVID-19 and COVID-19 vaccine
Attitude towards COVID-19; Knowledge about COVID-19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with COVID-19 Vaccine Hesitancy
Time Frame: through study completion, an average of 1 year
In the questionnaire, participants who expressed hesitancy or explicitly refused to receive the COVID-19 vaccine were considered vaccine hesitancy.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Study Director: Yongbing Qian, Prof, The department of Liver Surgery, Renji Hospital Shanghai Jiao Tong University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 27, 2022

Primary Completion (Actual)

May 10, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2022-138-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

This retrospective study involves the privacy of the participants. We need to keep it confidential and do not plan to share the data. If you want to know the relevant information, you can contact the principal person in charge of the study

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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