Pneumococcal VaccinesNCT06000397
Reminder Emails to Improve Pneumococcal Vaccine Completion at 12 Months of Age
A study testing Enhanced reminders and Standard CANImmunize notifications in people with Pneumococcal Vaccines and Immunization Coverage, run by Ottawa Hospital Research Institute at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 10 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccines, Immunization Coverage
- What is being tested?
- Enhanced reminders and Standard CANImmunize notifications
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2023to Jun 2024
- 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 10 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CANImmunize
Ottawa
Kathryn MacDonald, 613-293-1193, kathryn@canimmunize.ca
About this study
Official title: 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.
- Conditions
- Pneumococcal Vaccines, Immunization Coverage
- Being tested
- Enhanced reminders, Standard CANImmunize notifications
- Keywords
- Vaccine coverage, Vaccine uptake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced remindersOther
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 notificationsOther
Push notifications at two time points:
- two weeks prior to the immunization due date
- one week after the immunization due date
| Study group | Role | What they receive |
|---|---|---|
| Enhanced reminders | Experimental | Not described Receives: Other: Enhanced reminders |
| Standard notifications | Active comparator | Not described Receives: Other: Standard CANImmunize notifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of 12-month pneumococcal vaccine
Receipt of the 12-month dose of the pneumococcal vaccine as recorded in the CANImmunize immunization record
Measured: 12 months of age
Secondary outcomes (1)
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
Measured: 12-13 months of age will be considered as timely, after 13 months considered late
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start7 Nov 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal VaccinesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000397
- Sponsor's protocol ID
- 20220678-01H
- Status last verified
- Apr 2024
- First submitted
- 14 Aug 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents' Enhanced Reminder Intervention to Improve Children's Timely Completion of Immunization Series of Pneumococcal Vaccine at the 12-month's Visit
- ClinicalTrials.gov ID
- NCT06000397
- Acronym / sponsor ID
- 20220678-01H
- Conditions
- Pneumococcal Vaccines, Immunization Coverage
- Keywords
- Vaccine coverage, Vaccine uptake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 21 Aug 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced reminders | Experimental | Other: Enhanced reminders |
| Standard notifications | Active comparator | Other: Standard CANImmunize notifications |
Who may qualify
- Ages
- 10 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Enhanced remindersThe 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 | Other | Enhanced reminders |
| Standard CANImmunize notificationsPush notifications at two time points: * two weeks prior to the immunization due date * one week after the immunization due date | Other | Standard notifications |
Primary outcome
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
1 secondary outcome
Timeliness of 12-month pneumococcal vaccine
Time frame: 12-13 months of age will be considered as timely, after 13 months considered late
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced reminders and Standard CANImmunize notifications in people with Pneumococcal Vaccines and Immunization Coverage, run by Ottawa Hospital Research Institute 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 3 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn MacDonald (613-293-1193, kathryn@canimmunize.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of 12-month pneumococcal vaccine (time frame: 12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2024.