Mobile AppsNCT05794113
Comparing the Use of a Mobile App for Surveillance of Adverse Events Following Influenza Immunization to a Web-Based Platform
A study testing Mobile app - CanImmunize and Web based notification in people with Mobile Apps and Immunization, run by The Ottawa Hospital at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobile Apps, Immunization, Adverse Event Following Immunisation
- What is being tested?
- Mobile app - CanImmunize and Web based notification
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,408 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speak English or French,
- Have an active email address and telephone • Immunized with the seasonal influenza vaccine
- Parents of children are eligible to participate after the first or second dose of vaccine
Who cannot join
- Those who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Use of a Mobile App for Surveillance of Adverse Events Following Influenza Immunization to a Web-Based Platform: a Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Mobile app - CanImmunize, Web based notification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app - CanImmunizeDevice
Using a mobile app
Web based notificationDevice
Using a web-based version of a survey
| Study group | Role | What they receive |
|---|---|---|
| Web-based notification arm | Active comparator | All participants randomized to the web-based notification arm received the following web-based CANVAS notifications [4,5]. 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. Receives: Device: Web based notification |
| Mobile app arm | Experimental | 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. Receives: Device: Mobile app - CanImmunize |
What is being measured
The primary outcome is the main question the study is designed to answer.
Useability
Following completion of the safety survey, all participants were sent a separate link by email to complete a user experience survey. Participants were asked about their history of participating in the flu vaccine safety survey and whether they previously used the CANImmunize app. Using a Likert scale, participants were asked questions on (i) perceived ease of use, (ii) perceived usefulness, (iii) their attitudes and intention of use towards the platform and (iv) questions pertaining to vaccine confidence and safety.
Measured: through study completion - average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Oct 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobile AppsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,408 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Ottawa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kumanan Wilson, The Ottawa Hospital
- Investigators
- Anne McCarthy, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794113
- Sponsor's protocol ID
- #20200591-01H
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bota AB, Bettinger JA, Sarfo-Mensah S, Lopez J, Smith DP, Atkinson KM, Bell C, Marty K, Serhan M, Zhu DT, McCarthy AE, Wilson K. Comparing the Use of a Mobile App and a Web-Based Notification Platform for Surveillance of Adverse Events Following Influenza Immunization: Randomized Controlled Trial. JMIR Public Health Surveill. 2023 May 8;9:e39700. doi: 10.2196/39700.
PubMed 37155240
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Use of a Mobile App for Surveillance of Adverse Events Following Influenza Immunization to a Web-Based Platform: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05794113
- Acronym / sponsor ID
- #20200591-01H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,408 participants (actual)
- Lead sponsor
- The Ottawa HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based notification arm | Active comparator | Device: Web based notificationAll participants randomized to the web-based notification arm received the following web-based CANVAS notifications [4,5]. 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. |
| Mobile app arm | Experimental | Device: Mobile app - CanImmunizeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Speak English or French,
- Have an active email address and telephone • Immunized with the seasonal influenza vaccine
- Parents of children are eligible to participate after the first or second dose of vaccine
Key exclusion criteria (1 listed)
- Those who do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile app - CanImmunizeUsing a mobile app | Device | Mobile app arm |
| Web based notificationUsing a web-based version of a survey | Device | Web-based notification arm |
Primary outcome
Useability
Time frame: through study completion - average of 4 months
Following completion of the safety survey, all participants were sent a separate link by email to complete a user experience survey. Participants were asked about their history of participating in the flu vaccine safety survey and whether they previously used the CANImmunize app. Using a Likert scale, participants were asked questions on (i) perceived ease of use, (ii) perceived usefulness, (iii) their attitudes and intention of use towards the platform and (iv) questions pertaining to vaccine confidence and safety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Derived from this study: PubMed 37155240Bota AB, Bettinger JA, Sarfo-Mensah S, Lopez J, Smith DP, Atkinson KM, Bell C, Marty K, Serhan M, Zhu DT, McCarthy AE, Wilson K. Comparing the Use of a Mobile App and a Web-Based Notification Platform for Surveillance of Adverse Events Following Influenza Immunization: Randomized Controlled Trial. JMIR Public Health Surveill. 2023 May 8;9:e39700. doi: 10.2196/39700.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne McCarthy principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app - CanImmunize and Web based notification in people with Mobile Apps and Immunization, run by The Ottawa Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Useability (time frame: through study completion - average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05794113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.