NCT05033860

Brief Summary

Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus, which has developed the global pandemic situation. The promotion of vaccination is an effective strategy to control the epidemic. A total of 19,5738,000 doses of COVID-19 vaccines have been reported in China until August 24th, 2021. During widespread vaccination, the education in COVID-19 prevention and vaccination for residents are also crucial. To figure out the influence of education during waiting time of vaccination, we have designed a randomized controlled trial and planned to distribute leaflets and questionnaires to the residents of Xidian (a town in Ninghai, Zhejiang). This study is of great significance for the prevention of COVID-19 pandemic.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

August 30, 2021

Last Update Submit

September 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scores of the questionnaire

    All the participants are asked to fulfill a questionnaire entitled "A survey on the public knowledge of COVID-19 and vaccination". The total score of questionnaire is calculated (full mark is 24). A higher score means a better knowledge of COVID-19 and vaccination.

    5-20 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

Leaflets containing knowledge of COVID-19 and vaccination were distributed, and questionnaire surveys were conducted afterwards.

Other: Read leaflets containing knowledge of COVID-19 and vaccination.

Control group

NO INTERVENTION

Questionnaire surveys were conducted without leaflets distribution.

Interventions

Leaflets containing knowledge of COVID-19 and vaccination were distributed, and participants are asked to read the leaflets.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18;
  • Residents who are vaccinated with COVID-19 vaccines at Xidian Passenger Station from August 18th to September 20th, 2021;
  • Able to understand the content of leaflets and questionnaires, and willing to participate in the study.

You may not qualify if:

  • Residents who are unable to get vaccinated with COVID-19 vaccines;
  • Unable to understand the content of leaflets and questionnaires, or unwilling to participate in the study;
  • Unreturned or incomplete questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

RECRUITING

MeSH Terms

Conditions

COVID-19Behavior

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 1. Intervention group: leaflets containing knowledge of COVID-19 and vaccination were distributed, and questionnaire surveys were conducted afterwards. 2. Control group: questionnaire surveys were conducted without leaflets distribution.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 5, 2021

Study Start

August 18, 2021

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations