VaccinationNCT06666868
CARD for Community Pharmacy Vaccinations - Phase 2
A study testing Sustained CARD and First-time CARD in people with Vaccination and Vaccination Pain, run by University of Toronto at 1 site in Canada.
Trial summary
This study is phase 2 of a cluster trial integrating the CARD (Comfort Ask Relax System) in community pharmacies affiliated with Wholehealth Pharmacy Partners. It involves continuing CARD in pharmacies randomized to CARD in phase 1 of the trial (2023-2024 fall/winter vaccination season), and initiating CARD in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vaccination, Vaccination Pain, Vaccination Reaction
- What is being tested?
- Sustained CARD and First-time CARD
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2024to 31 Aug 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clients undergoing vaccination in participating pharmacies and providers working in participating pharmacies
Who cannot join
- able to speak and write in English
Trial locations and contacts
1 site in 1 country.
Canada1 site
Leslie Dan Faculty of Pharmacy, University of Toronto
Toronto, Ontario, M5S 3M2
Anna Taddio, PhD, 416-978-2889, anna.taddio@utoronto.ca
Anna Taddio, PhD
About this study
Official title: CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations - Phase 2
This study is phase 2 of a cluster trial integrating the CARD (Comfort Ask Relax System) in community pharmacies affiliated with Wholehealth Pharmacy Partners. It involves continuing CARD in pharmacies randomized to CARD in phase 1 of the trial (2023-2024 fall/winter vaccination season), and initiating CARD in pharmacies randomized to Control (usual care) in phase 1 of the trial. Both groups will use CARD for delivery of vaccinations during the 2024-2025 fall/winter vaccination season.
Read the detailed description
This study is a continuation of a previous cluster trial. Pharmacies that participated in the original trial will be asked if they want to volunteer for the present study. They will all use the CARD system as the vaccination delivery system for their community pharmacies during the 2024-2025 fall/winter vaccination season. They will collect feedback from vaccine clients using a paper survey that tracks experiences, including symptoms, during vaccination. The responses will be compared between groups.
The sample size is limited by the number of pharmacies that volunteer. We expect 8 pharmacies will participate in a 1:1 ratio (about 1/3 of all pharmacies in original cluster trial), with a total of at least 500 vaccination clients. We will collect data for all vaccinations that are conducted and for which client feedback data are available. Thus, the sample size is expected to deviate from the estimated sample size of 500.
- Being tested
- Sustained CARD, First-time CARD
- Keywords
- vaccination reaction, vaccination experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained CARDBehavioural
Also called Sustained CARD use
This group is using CARD for the 2nd year in a row in participating pharmacies as the vaccination delivery framework (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter vaccination season).
First-time CARDBehavioural
Also called First-time CARD use
CARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season).
| Study group | Role | What they receive |
|---|---|---|
| Sustained CARD | Experimental | CARD is being used for the 2nd year in a row as the vaccination delivery framework in participating pharmacies (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter season). CARD comprises of education, environment, engagement and evaluation components. Receives: Behavioral: Sustained CARD |
| First-time CARD | Active comparator | CARD is being used for the 1st time as the vaccination delivery framework in participating pharmacies (2024-2025 fall/winter vaccinations only). CARD comprises of education, environment, engagement and evaluation components. Receives: Behavioral: First-time CARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience with vaccination
Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized)
Measured: Within 15 minutes of vaccination
Secondary outcomes (7)
Pain
Self-reported pain during vaccination (0-10)
Measured: Within 15 minutes of vaccination
Fear
Self-reported fear during vaccination (0-10)
Measured: Within 15 minutes of vaccination
Dizziness
Self-reported dizziness during vaccination (0-10)
Measured: Within 15 minutes of vaccination
Fainting
Self-reported fainting during vaccination (yes/no) confirmed by provider
Measured: Within 15 minutes of vaccination
Overall experience
Self-reported overall experience (5-point Likert scale, and dichotomized)
Measured: Within 15 minutes of vaccination
Vaccination decision-making
Self-reported vaccination decision-making (5-point Likert scale, and dichotomized)
Measured: Within 15 minutes of vaccination
Implementation outcomes
Provider quantitative and qualitative feedback on surveys and interviews (assessing implementation outcomes)
Measured: Within 3 months of vaccination season ending
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start5 Nov 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster trial involving at least 8 community pharmacies allocated in a 1:1 ratio to: 1) repeat use or 2) first-time use of the CARD system for vaccination delivery in 2024-2025 fall/winter vaccination season.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Wholehealth Pharmacy Partners
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
- Investigators
- Anna Taddio, PhD, Principal investigator, Leslie Dan Faculty Of Pharmacy, University Of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666868
- Sponsor's protocol ID
- 43097-2024
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 31 Oct 2024
- 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 individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. 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 - Phase 2
- ClinicalTrials.gov ID
- NCT06666868
- Acronym / sponsor ID
- 43097-2024
- Keywords
- vaccination reaction, vaccination experience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Wholehealth Pharmacy Partners
- Study start
- 5 Nov 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 31 Oct 2024 (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.
This study is phase 2 of a cluster trial integrating the CARD (Comfort Ask Relax System) in community pharmacies affiliated with Wholehealth Pharmacy Partners. It involves continuing CARD in pharmacies randomized to CARD in phase 1 of the trial (2023-2024 fall/winter vaccination season), and initiating CARD in pharmacies randomized to Control (usual care) in phase 1 of the trial. Both groups will use CARD for delivery of vaccinations during the 2024-2025 fall/winter vaccination season.
Detailed description
This study is a continuation of a previous cluster trial. Pharmacies that participated in the original trial will be asked if they want to volunteer for the present study. They will all use the CARD system as the vaccination delivery system for their community pharmacies during the 2024-2025 fall/winter vaccination season. They will collect feedback from vaccine clients using a paper survey that tracks experiences, including symptoms, during vaccination. The responses will be compared between groups.
The sample size is limited by the number of pharmacies that volunteer. We expect 8 pharmacies will participate in a 1:1 ratio (about 1/3 of all pharmacies in original cluster trial), with a total of at least 500 vaccination clients. We will collect data for all vaccinations that are conducted and for which client feedback data are available. Thus, the sample size is expected to deviate from the estimated sample size of 500.
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 8 community pharmacies allocated in a 1:1 ratio to: 1) repeat use or 2) first-time use of the CARD system for vaccination delivery in 2024-2025 fall/winter vaccination season.
| Arm | Type | Receives |
|---|---|---|
| Sustained CARD | Experimental | Behavioral: Sustained CARDCARD is being used for the 2nd year in a row as the vaccination delivery framework in participating pharmacies (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter season). CARD comprises of education, environment, engagement and evaluation components. |
| First-time CARD | Active comparator | Behavioral: First-time CARDCARD is being used for the 1st time as the vaccination delivery framework in participating pharmacies (2024-2025 fall/winter vaccinations only). CARD comprises of education, environment, engagement and evaluation components. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- clients undergoing vaccination in participating pharmacies and providers working in participating pharmacies
Key exclusion criteria (1 listed)
- able to speak and write in 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 |
|---|---|---|
| Sustained CARDAlso: Sustained CARD useThis group is using CARD for the 2nd year in a row in participating pharmacies as the vaccination delivery framework (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter vaccination season). | Behavioural | Sustained CARD |
| First-time CARDAlso: First-time CARD useCARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season). | Behavioural | First-time CARD |
Primary outcome
Experience with vaccination
Time frame: Within 15 minutes of vaccination
Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized)
7 secondary outcomes
Pain
Time frame: Within 15 minutes of vaccination
Fear
Time frame: Within 15 minutes of vaccination
Dizziness
Time frame: Within 15 minutes of vaccination
Fainting
Time frame: Within 15 minutes of vaccination
Overall experience
Time frame: Within 15 minutes of vaccination
Vaccination decision-making
Time frame: Within 15 minutes of vaccination
Implementation outcomes
Time frame: Within 3 months of vaccination season ending
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. We do not have permission to share individual participant data.
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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
Leslie Dan Faculty Of Pharmacy, 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 Sustained CARD and First-time CARD in people with Vaccination 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 1 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 31 Oct 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 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 of vaccination). 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 31 Oct 2024.