NCT05794113

Comparing the Use of a Mobile App for Surveillance of Adverse Events Following Influenza Immunization to a Web-Based Platform

Completed NA Last updated 3 April 2023

What this trial tests

NA trial testing Mobile app - CanImmunize in Mobile Apps in 2,408 participants. Completed in 1 October 2021.

Timeline

1 October 2020

Primary endpoint
1 October 2021

1 October 2021

Quick facts

Lead sponsor	The Ottawa Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	2,408
Start date	1 October 2020
Primary completion	1 October 2021
Estimated completion	1 October 2021
Sites	1 location across Canada

Drugs / interventions tested

• Mobile app - CanImmunize
• Web based notification

Conditions studied

• Mobile Apps — all drugs for Mobile Apps →
• Immunization — all drugs for Immunization →
• Adverse Event Following Immunisation — all drugs for Adverse Event Following Immunisation →

Sponsor

The Ottawa Hospital

Who can join

18 and older, any sex, with Mobile Apps or Immunization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Methods Study Procedures A two-centred randomized control trial (RCT) was conducted to evaluate the use of safety reporting via a mobile app compared to safety reporting via web-based CANVAS notifications amongst individuals receiving the influenza vaccine from October 6 to November 29, 2020 during the seasonal influenza vaccine campaign in Ottawa and Vancouver, Canada.

Individuals were recruited at the time of receiving their influenza vaccine. Eligibility criteria included the ability to speak English or French, having an active email address and telephone number, and being immunized with the seasonal influenza vaccine.

Randomization After study enrollment, participants were randomized to receive the online safety survey either through the mobile app or emailed a link to the online survey using a four-block randomization design.

Web-based notification arm All participants randomized to the web-based notification arm received the following web-based CANVAS notifications. Briefly, participants received an email notifying them of their registration in the study. Eight days following their influenza vaccine, participants received an email with the survey link asking them to complete their online influenza vaccine safety survey. Participants received a reminder email on day 11 if they did not complete their survey. Further details on CANVAS surveillance and description of the questionnaire can be found here.

Mobile app arm Participants randomized to the mobile app arm, received an email asking them to download the app and activate their account. Users who did not activate their account after 48 hours received a reminder email. Participants who activated their accounts, could spontaneously report an adverse event through the app, and were also notified of the day 8 survey through the app.

Eight days following their vaccination mobile app participants who activated their account received a push notification on their phone to complete their survey. A reminder push notice was sent out on day 11 to participants that had not yet competed the day 8 survey. On November 16, 2020 (mid-way through the recruitment period), additional email reminders in the mobile app arm were implemented on days 2, 4 and 6 to remind participants to register for the app. All participants received a day 8 email directing them to use their CANImmunize account to complete their influenza vaccine survey. Access to the survey link also was available in the email reminder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparing the Use of a Mobile App and a Web-Based Notification Platform for Surveillance of Adverse Events Following Influenza Immunization: Randomized Controlled Trial.
   Bota AB, Bettinger JA, Sarfo-Mensah S, Lopez J, et al · · 2023 · cited 3× · PMID 37155240 · DOI 10.2196/39700