Enabling Family Physicians to Reduce Vaccine Hesitancy and Increase Covid-19 Vaccine Uptake
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|ClinicalTrials.gov Identifier: NCT04963790|
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : March 1, 2023
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The approval and distribution of COVID-19 vaccines is an important milestone in the fight against the pandemic. However, although vaccines are widely recognized as a key public health measure to control infectious disease, there are still people who remain hesitant to get vaccinated. In Canada, 83% of Canadian adults have received or are willing to receive the vaccine. However, nearly 20% of adults and a larger proportion of parents of younger children remain concerned about receiving vaccines. In the context of a project to enable family physicians to identify vaccine-hesitant patients and deliver a tailored COVID-19 vaccination outreach campaign, the Canadian Practice Information Network, a tool for primary care providers to communicate with their patients, will be used to engage and address vaccination hesitancy in Canada. The study will identify information needs about COVID-19 vaccination among community-dwelling patients in three Canadian provinces and will assess the effectiveness of a tailored COVID-19 vaccine digital health communication strategy for primary care practices to address vaccination hesitancy and improve COVID-19 vaccination uptake.
A two-arm cluster randomized trial design will be conducted in primary care practices in three Canadian provinces: Ontario, British Columbia, and New Brunswick. The study will use a convenience sample of primary care practice in these provinces. Recruited participants will be randomly allocated to the intervention and control groups. Patients assigned to the control group will receive health messages unrelated to the COVID-19.
Participants in the intervention group will receive a series of tailored messages on COVID-19 vaccination targeting the main factors for hesitancy to address their concerns and persuade them to receive the COVID-19 vaccine. Aggregated survey responses across practices will be used to create segments of unvaccinated patients reflecting age, language, education level, rurality, sex, gender, ethnicity, and their attitudes or reasons for vaccine hesitancy or access barriers. Then, tailored messages will be created in a way that is meaningful to the recipients in the different segments.
The primary outcome is the proportion of vaccine-hesitant individuals who receive a COVID-19 vaccine during the intervention period. The secondary outcome is the overall COVID-19 vaccine uptake.
|Condition or disease||Intervention/treatment||Phase|
|Covid19 COVID-19 Vaccine||Behavioral: Tailored COVID-19 vaccine messages Other: Other health messages||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients in the intervention group will receive a series of tailored messages on COVID-19 vaccination. Patients assigned to the control group will receive health messages unrelated to the COVID-19.|
|Masking:||None (Open Label)|
|Official Title:||Enabling Family Physicians to Reduce Vaccine Hesitancy and Increase COVID-19 Vaccine Uptake: a Cluster-randomized Trial|
|Actual Study Start Date :||November 14, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||June 2024|
Experimental: Tailored COVID-19 vaccine messaging
Based on the created segments of hesitant participants (reflecting age, language, education level, rurality, sex, gender, ethnicity, and attitudes or reasons for vaccine hesitancy) in the intervention group, a series of tailored messages that are meaningful to the recipients in the different segments will be created and sent to address the factors influencing the willingness to be vaccinated and persuade them to get the COVID-19 vaccine.
Behavioral: Tailored COVID-19 vaccine messages
Survey responses from participants will be aggregated to create hesitant patient segments. Then, specific content messages will be created following the health belief model, in a way that is meaningful to the recipients in the different segments, to persuade them to receive the COVID-19 vaccine.
Active Comparator: Other health-related messaging
Patients assigned to the control group will receive health messages unrelated to COVID-19.
Other: Other health messages
Other health messages unrelated to COVID-19 will be sent to participants in the control arm
- Proportion of hesitant individuals who received a COVID-19 vaccine [ Time Frame: 10 months ]The proportion of vaccine hesitant individuals who receive a COVID-19 vaccine during the intervention period
- Individual willingness to receive a COVID-19 vaccine [ Time Frame: 10 months ]The proportion of patients who are willing to receive a COVID-19 vaccine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Non-vaccinated adults
- Enrolled in a participating CPIN primary care practice
- Patients who don't speak one of Canada's official languages (English and French)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963790
|Contact: Julienne Niyikorafirstname.lastname@example.org|
|Eastern Ontario Health Unit||Recruiting|
|Cornwall, Ontario, Canada, K6J 5T1|
|Contact: Gretchen Seitz 613-966-1375 ext 1202 email@example.com|
|Principal Investigator:||Sharon Johnston, MD||Institut du Savoir Montfort|
|Principal Investigator:||William Hogg, MD||Institut du Savoir Montfort|
|Responsible Party:||Hopital Montfort|
|Other Study ID Numbers:||
|First Posted:||July 15, 2021 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
cluster randomized trial
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