Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT). (VaxNurse-RCT)

September 30, 2026 updated by: Corsenac Philippe, Universite du Quebec en Outaouais

Nurses play an important role in providing vaccine information and supporting informed vaccination decisions.

This study will evaluate a digital educational intervention designed for registered nurses in Quebec. The intervention will provide education about vaccination, including immunology, epidemiology, vaccine communication, motivational interviewing, and responding to vaccine misinformation.

Registered nurses will be randomly assigned to either the intervention group or a control group. The study will examine whether the intervention improves vaccine confidence and vaccine communication compared with the control group.

Participants will complete questionnaires before and after the intervention, with follow-up assessments at 3 and 6 months. The study will assess vaccine hesitancy and changes in vaccine-related knowledge, communication skills, and vaccination recommendation practices.

The findings will help determine whether a digital educational intervention can support nurses in their vaccine-related communication and professional practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Vaccine hesitancy can influence vaccine acceptance and communication between healthcare professionals and the public. Registered nurses have an important role in vaccination, including providing information, addressing concerns, and recommending vaccination.

This study will evaluate a digital educational intervention designed to strengthen knowledge related to vaccines, confidence, and communication among registered nurses in Quebec. The intervention will complement existing immunization training of INSPQ. It will integrate content on immunology, epidemiology, motivational interviewing, vaccine communication, and responses to vaccine misinformation.

The study will use a randomized controlled design with two parallel groups. Participants will be randomly assigned to the digital educational intervention + immunization training of INSPQ or the control condition (the immunization training of INSPQ, only). The intervention will be evaluated using measurements collected before and after the intervention and during follow-up (3 months and 6 months).

The primary focus will be the effect of the intervention on vaccine hesitancy of nurses. Secondary aims will include vaccine recommendation practices, immunological and epidemiological knowledge, and vaccine communication competencies.

Questionnaires will also examine psychosocial determinants of vaccination attitudes and behaviors. The pilot phase preceding the randomized trial will support refinement of the intervention, questionnaires, study procedures, and measurement instruments.

The study aims to generate evidence on whether digital education can strengthen nurses' vaccine-related competencies and support their communication with patients and the public.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Canada
      • Saint-Jérôme, Canada, J7Z 0B7
        • Université du Québec en Outaouais
        • Principal Investigator:
          • Philippe Corsenac, Ph.D.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 62 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Registered nurse authorized to practice in Quebec.
  • Aged 18 years or older.
  • Able to provide informed consent.
  • Able to complete the study questionnaires in French or English and digital educational intervention in French.

Exclusion Criteria:

  • Not currently authorized to practice as a registered nurse in Quebec.
  • Unable to provide informed consent.
  • Previous participation in the VaxNurse pilot study.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital educational intervention + immunization training of INSPQ

Registered nurses assigned to this arm will receive the digital educational intervention in addition to the existing immunization training provided by the INSPQ. The digital intervention will include immunology, epidemiology, motivational interviewing, vaccine communication, and strategies for responding to vaccine misinformation.
Other: Digital educational intervention

The VaxNurse digital educational intervention is designed for registered nurses. It includes educational content on immunology and epidemiology, motivational interviewing, vaccine communication, and strategies for responding to vaccine misinformation. The intervention aims to reduce vaccine hesitancy and strengthen knowledge related to vaccine, confidence, communication skills, and recommendation practices. It complements existing immunization training provided by the INSPQ.
Experimental: Control

Registered nurses assigned to this arm will receive the existing immunization training provided by the INSPQ without the additional digital educational intervention.
Other: Digital educational intervention

The VaxNurse digital educational intervention is designed for registered nurses. It includes educational content on immunology and epidemiology, motivational interviewing, vaccine communication, and strategies for responding to vaccine misinformation. The intervention aims to reduce vaccine hesitancy and strengthen knowledge related to vaccine, confidence, communication skills, and recommendation practices. It complements existing immunization training provided by the INSPQ.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the Vaccine Hesitancy Scale (VHS)
Time Frame: Baseline (T0), immediately post-intervention (Ti), 3 months, and 6 months

Vaccine hesitancy will be assessed using the Vaccine Hesitancy Scale (VHS). The total score ranges from 10 to 50, with higher scores indicating greater vaccine hesitancy. Change from baseline will be compared between the intervention and control groups across follow-up assessments.
Baseline (T0), immediately post-intervention (Ti), 3 months, and 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universite du Quebec en Outaouais

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McGill University
Université Victor Segalen Bordeaux 2
Ministere de la Sante et des Services Sociaux
Angers University
ordre des infirmières et des infirmiers du Québec

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe Corsenac, Ph.D., Université du Québec en Outaouais

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDC-453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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