Vaccination ReactionNCT06098703
CARD for Community Pharmacy Vaccinations
A study testing CARD (Comfort Ask Relax Distract) in people with Vaccination Reaction and Vaccination Pain, run by University of Toronto at 1 site in Canada.
Trial summary
To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Reaction, Vaccination Pain, Community Pharmacy
- What is being tested?
- CARD (Comfort Ask Relax Distract)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 31 Dec 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- vaccine clients being vaccinated in community pharmacies participating in the project
- pharmacy staff in community pharmacies participating in the project
Who cannot join
- unable to understand and read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations
To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.
Read the detailed description
It is estimated that 1 out of 5 children and adults are not vaccinated because of concerns about pain and fear. The CARD (Comfort Ask Relax Distract) system is a new vaccine delivery system proven to reduce pain, fear and immunization stress-related responses. Improving the vaccination experiences of patients can improve attitudes about vaccination and increase vaccine acceptance.
The objective of this cluster randomized trial is to evaluate scaling of CARD across community pharmacies on patients vaccination symptoms, beliefs and attitudes and pharmacy staff beliefs and attitudes.
- Conditions
- Vaccination Reaction, Vaccination Pain, Community Pharmacy
- Being tested
- CARD (Comfort Ask Relax Distract)
- Keywords
- Vaccination reaction, Vaccination experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARD (Comfort Ask Relax Distract)Behavioural
CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations
| Study group | Role | What they receive |
|---|---|---|
| CARD (multi-faceted intervention) | Experimental | CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback). Receives: Behavioral: CARD (Comfort Ask Relax Distract) |
| Control (standard care) | No intervention | There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience with vaccination
Vaccine client self-reported experience with vaccination (better or not)
Measured: within 15 minutes after vaccination
Secondary outcomes (10)
Fear
Vaccine client self-reported fear during vaccination (0-10)
Measured: within 15 minutes after vaccination
Pain
Vaccine client self-reported pain during vaccination (0-10)
Measured: within 15 minutes after vaccination
Dizziness
Vaccine client self-reported dizziness during vaccination (0-10)
Measured: within 15 minutes after vaccination
Fainting
Fainting during/after vaccination (yes/no)
Measured: within 15 minutes after vaccination
Utilization of coping strategies during vaccination
Use of individual coping strategies during vaccination (e.g., distraction, support person) (yes/no)
Measured: within 5 minutes of vaccination
CARD satisfaction survey
Vaccine client self-reported satisfaction with CARD (e.g., helpfulness, willingness to use again, willingness to return for next vaccination, vaccination decision-making, as applicable), responses reported for individual items
Measured: within 15 minutes of vaccination
Implementation success of CARD
Perceptions of implementation success of CARD program delivery as reported by CARD implementers (primary targets) using CARD Global Impression Checklist, individual questions (5-point Likert Scale higher number represents better outcome); responses reported for individual items. This information is supplemented with focus group information and study notes.
Measured: within 3 months of vaccination clinics
Attitudes about vaccination
Perceptions of CARD and non-CARD implementers using CARD Attitudes survey, individual questions (5-point Likert Scale higher number represents better outcome); responses reported for individual items. This information is supplemented with focus group information and study notes.
Measured: within 3 months of vaccination clinics
Vaccination behaviours
Self-reported vaccine behaviours of immunizers using CARD Behaviour Survey, individual questions (rank as whether behaviours are done or not); responses reported for individual items. Includes CARD and non-CARD implementers.
Measured: within 3 months of vaccination clinics
Vaccine interaction survey
Perceptions of CARD and non-CARD immunizers about vaccination interaction [duration, satisfaction, CARD usefulness (intervention group only)]; responses reported for individual items.
Measured: within 5 minutes of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaccination ReactionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster trial involving at least 24 community pharmacies allocated to CARD or control (standard care) in a 1:1 ratio. Eligible pharmacies belonging to Wholehealth Pharmacy Partners from across Ontario, Canada, will be included.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC), Wholehealth Pharmacy Partners
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
- Investigators
- Anna Taddio, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098703
- Sponsor's protocol ID
- 43097
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have permission to share this information.
Publications
Taddio A, Morrison J, Logeman C, Gudzak V, Bucci LM, McMurtry CM, Yang M, Folinas M, Moineddin R, MacDonald NE. CARD (Comfort Ask Relax Distract) and community pharmacy vaccinations: Evaluation of effectiveness outcomes from a cluster randomized trial. Hum Vaccin Immunother. 2025 Dec;21(1):2488064. doi: 10.1080/21645515.2025.2488064. Epub 2025 Aug 6.
PubMed 40768541Taddio A, Morrison J, Logeman C, Gudzak V, Bucci LM, McMurtry CM, Yang M, Folinas M, Moineddin R, MacDonald NE. CARD (Comfort Ask Relax Distract) and community pharmacy vaccinations: Evaluation of implementation outcomes from a cluster randomized trial. Hum Vaccin Immunother. 2025 Dec;21(1):2503524. doi: 10.1080/21645515.2025.2503524. Epub 2025 May 15.
PubMed 40371950
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations
- ClinicalTrials.gov ID
- NCT06098703
- Acronym / sponsor ID
- 43097
- Conditions
- Vaccination Reaction, Vaccination Pain, Community Pharmacy
- Keywords
- Vaccination reaction, Vaccination experience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC), Wholehealth Pharmacy Partners
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Oct 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.
To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.
Detailed description
It is estimated that 1 out of 5 children and adults are not vaccinated because of concerns about pain and fear. The CARD (Comfort Ask Relax Distract) system is a new vaccine delivery system proven to reduce pain, fear and immunization stress-related responses. Improving the vaccination experiences of patients can improve attitudes about vaccination and increase vaccine acceptance.
The objective of this cluster randomized trial is to evaluate scaling of CARD across community pharmacies on patients vaccination symptoms, beliefs and attitudes and pharmacy staff beliefs and attitudes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster trial involving at least 24 community pharmacies allocated to CARD or control (standard care) in a 1:1 ratio. Eligible pharmacies belonging to Wholehealth Pharmacy Partners from across Ontario, Canada, will be included.
| Arm | Type | Receives |
|---|---|---|
| CARD (multi-faceted intervention) | Experimental | Behavioral: CARD (Comfort Ask Relax Distract)CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback). |
| Control (standard care) | No intervention | –There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- vaccine clients being vaccinated in community pharmacies participating in the project
- pharmacy staff in community pharmacies participating in the project
Key exclusion criteria (1 listed)
- unable to understand and read English
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 |
|---|---|---|
| CARD (Comfort Ask Relax Distract)CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations | Behavioural | CARD (multi-faceted intervention) |
Primary outcome
Experience with vaccination
Time frame: within 15 minutes after vaccination
Vaccine client self-reported experience with vaccination (better or not)
10 secondary outcomes
Fear
Time frame: within 15 minutes after vaccination
Pain
Time frame: within 15 minutes after vaccination
Dizziness
Time frame: within 15 minutes after vaccination
Fainting
Time frame: within 15 minutes after vaccination
Utilization of coping strategies during vaccination
Time frame: within 5 minutes of vaccination
CARD satisfaction survey
Time frame: within 15 minutes of vaccination
Implementation success of CARD
Time frame: within 3 months of vaccination clinics
Attitudes about vaccination
Time frame: within 3 months of vaccination clinics
Vaccination behaviours
Time frame: within 3 months of vaccination clinics
Vaccine interaction survey
Time frame: within 5 minutes of vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Derived from this study: PubMed 40768541Taddio A, Morrison J, Logeman C, Gudzak V, Bucci LM, McMurtry CM, Yang M, Folinas M, Moineddin R, MacDonald NE. CARD (Comfort Ask Relax Distract) and community pharmacy vaccinations: Evaluation of effectiveness outcomes from a cluster randomized trial. Hum Vaccin Immunother. 2025 Dec;21(1):2488064. doi: 10.1080/21645515.2025.2488064. Epub 2025 Aug 6.
- Derived from this study: PubMed 40371950Taddio A, Morrison J, Logeman C, Gudzak V, Bucci LM, McMurtry CM, Yang M, Folinas M, Moineddin R, MacDonald NE. CARD (Comfort Ask Relax Distract) and community pharmacy vaccinations: Evaluation of implementation outcomes from a cluster randomized trial. Hum Vaccin Immunother. 2025 Dec;21(1):2503524. doi: 10.1080/21645515.2025.2503524. Epub 2025 May 15.
- Individual participant dataSharing planned: No. We do not have permission to share this information.
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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.
Anna Taddio, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARD (Comfort Ask Relax Distract) in people with Vaccination Reaction and Vaccination Pain, run by University of Toronto 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 2 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: status not confirmed, as of the sponsor's last update on 25 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Logeman, MPH (416-978-2889, charlotte.logeman@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience with vaccination (time frame: within 15 minutes after vaccination). 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 NCT06098703, which also lists 2 linked publications.
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 25 Oct 2023.