CARD for Community Pharmacy Vaccinations - Phase 2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
clients undergoing vaccination in participating pharmacies and providers working in participating pharmacies
Disqualifiers
able to speak and write in English
Trial design
Design model
Parallel
Treatments tested in this trial
Sustained CARD
BehavioralThis 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 CARD
BehavioralCARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season).
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Sustained CARDExperimental treatment 1 intervention
Group B: First-time CARDActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Experience with vaccination
Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized)
Time frame
Within 15 minutes of vaccinationSecondary outcomes
1
Pain
Self-reported pain during vaccination (0-10)
Time frame
Within 15 minutes of vaccination2
Fear
Self-reported fear during vaccination (0-10)
Time frame
Within 15 minutes of vaccination3
Dizziness
Self-reported dizziness during vaccination (0-10)
Time frame
Within 15 minutes of vaccination4
Fainting
Self-reported fainting during vaccination (yes/no) confirmed by provider
Time frame
Within 15 minutes of vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Toronto
Lead sponsor
Wholehealth Pharmacy Partners
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: