Reminder Emails to Improve Pneumococcal Vaccine Completion at 12 Months of Age

April 8, 2024 updated by: Ottawa Hospital Research Institute

Parents' Enhanced Reminder Intervention to Improve Children's Timely Completion of Immunization Series of Pneumococcal Vaccine at the 12-month's Visit

The goal of this clinical trial is to assess the effectiveness of enhanced email reminders in improving vaccine coverage at the 12-month visit in CANImmunize app users. The main questions it aims to answer are:

  • Do enhanced email reminders improve coverage of the 12- month dose of the pneumococcal vaccine and the timely completion of its immunization series at the 12-month's visit in CANImmunize app users?
  • What are the predictors of predictors of timely completion of the 12-month's series of pneumococcal vaccines in the CANImmunize app users?

Participants will be randomized to either receive enhanced reminder/recall materials via email or the standard CANImmunize notifications. Researchers will compare the enhanced reminder group to the standard notification group to see if there is a difference in vaccine coverage at the 12-month visit.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • 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 Contact

Study Locations

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

To be included in the study, CANImmunize account holders must have:

  • Enabled the reception to receive emails from CANImmunize, and
  • Record(s) for an infant aged between 10- and 11-months, who have already received the earlier doses of the pneumococcal vaccine in accordance with their provincial/territorial routine immunization schedule.

Exclusion Criteria

  • The account holder (parent, or guardian of the child) has an inactive or undelivered email address, or
  • No record(s) for an infant aged 10- and 11-months, or
  • The record for the 10- or 11-month-old indicates that he/she has not received the prior pneumococcal vaccine doses.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced reminders
Other: Enhanced reminders

The intervention is sending enhanced (modality and frequency) of reminders to CANImmunize App users, in addition to the standard notifications. Specifically:

  • Deliver reminders and recall emails to parents or guardians of infants waiting for their 12-month dose of pneumococcal vaccine,
  • Add additional information about the benefits, safety and effectiveness of the pneumococcal vaccine to support increased uptake, and
  • Provide tips to improve parents' or guardians' self-efficacy in circumventing barriers to timely immunization of children at the 12-month's visit
Active Comparator: Standard notifications
Other: Standard CANImmunize notifications

Push notifications at two time points:

  • two weeks prior to the immunization due date
  • one week after the immunization due date

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of 12-month pneumococcal vaccine
Time Frame: 12 months of age
Receipt of the 12-month dose of the pneumococcal vaccine as recorded in the CANImmunize immunization record
12 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeliness of 12-month pneumococcal vaccine
Time Frame: 12-13 months of age will be considered as timely, after 13 months considered late
Age at receipt of the 12-month dose of the pneumococcal vaccine as recorded in the CANImmunize immunization record
12-13 months of age will be considered as timely, after 13 months considered late

Collaborators and Investigators

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

Sponsor

Ottawa Hospital Research Institute

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)

November 7, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20220678-01H

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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