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临床试验/NCT06098703
NCT06098703尚未招募不适用

CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations

University of Toronto2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,000
试验地点
2
主要终点
Experience with vaccination

研究概览

简要总结

To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Vaccine recipients will not be aware of whether they are in the intervention or control group or the objective of the trial. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are in the intervention pharmacies will not deliver care to participants in the control pharmacies and care providers in the control pharmacies will not deliver care in the intervention pharmacies. Vaccine recipients are rating the primary outcome.

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • vaccine clients being vaccinated in community pharmacies participating in the project
  • pharmacy staff in community pharmacies participating in the project

排除标准

  • unable to understand and read English

结局指标

主要结局

Experience with vaccination

时间窗: within 15 minutes after vaccination

Vaccine client self-reported experience with vaccination (better or not)

次要结局

  • Attitudes about vaccination(within 3 months of vaccination clinics)
  • Fear(within 15 minutes after vaccination)
  • Pain(within 15 minutes after vaccination)
  • Dizziness(within 15 minutes after vaccination)
  • Fainting(within 15 minutes after vaccination)
  • Utilization of coping strategies during vaccination(within 5 minutes of vaccination)
  • CARD satisfaction survey(within 15 minutes of vaccination)
  • Implementation success of CARD(within 3 months of vaccination clinics)
  • Vaccination behaviours(within 3 months of vaccination clinics)
  • Vaccine interaction survey(within 5 minutes of vaccination)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Taddio

Professor

University of Toronto

研究点 (2)

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