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

Pneumococcal Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000397
• Other study ID #: 20220678-01H
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: Kathryn MacDonald
• Phone: 613-293-1193
• Email: kathryn[@]canimmunize.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months to 11 Months

Eligibility

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.

Related Conditions & MeSH terms

• Immunization Coverage
• Pneumococcal Vaccines

Intervention

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
• Standard CANImmunize notifications
Push notifications at two time points: two weeks prior to the immunization due date one week after the immunization due date

Locations

Country	Name	City	State
Canada	CANImmunize	Ottawa

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of 12-month pneumococcal vaccine	Receipt of the 12-month dose of the pneumococcal vaccine as recorded in the CANImmunize immunization record	12 months of age
Secondary	Timeliness of 12-month pneumococcal vaccine	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