NCT06000397

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

August 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

August 14, 2023

Last Update Submit

April 8, 2024

Conditions

Keywords

Vaccine coverageVaccine uptake

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Timeliness of 12-month pneumococcal vaccine

    12-13 months of age will be considered as timely, after 13 months considered late

Study Arms (2)

Enhanced reminders

EXPERIMENTAL
Other: Enhanced reminders

Standard notifications

ACTIVE COMPARATOR
Other: Standard CANImmunize notifications

Interventions

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

Enhanced reminders

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

Standard notifications

Eligibility Criteria

Age10 Months - 11 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CANImmunize

Ottawa, Canada

RECRUITING

Central Study Contacts

Kathryn MacDonald

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2023

First Posted

August 21, 2023

Study Start

November 7, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations