- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385501
Educational Intervention to Improve Vaccine Acceptance
April 2, 2015 updated by: Elizabeth Williams, Vanderbilt University
This research project will develop an educational intervention to improve immunization acceptance by vaccine hesitant parents.
This is prospective interventional case-control trial, where the investigators will provide the intervention in the clinical setting.
Enrollees will be screened and selected if they meet criteria for "vaccine hesitancy".
The investigators will conduct follow up surveys following the intervention to assess change in attitude and follow immunization rates through 18 month well visit.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The intervention is a 8 minute video addressing common concerns that have been reported by vaccine hesitant parents.
The video includes an expert in pediatric infectious diseases answering these common questions as well as 3 parental accounts of children who contracted vaccine preventable diseases.
Also, the interventional group will be provided with two handouts: one listed information on how parents can find accurate vaccine information on the internet, and another that addresses more common concerns of vaccine hesitant parents and available for our use from the Children's Hospital of Philadelphia Vaccine Center website.
Study Type
Interventional
Enrollment (Actual)
155
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Franklin, Tennessee, United States
- Franklin Pediatric Associates
-
Nashville, Tennessee, United States
- University Pediatrics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- > 18 years old for parent
- < 30 days old for infant
- full term (>37 weeks gestational age) infant
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: routine care
|
|
Experimental: Educational intervention group
|
The interventional group will be shown an 8 minute video addressing common concerns of vaccine hesitant parents.
Then, they will be provided with a handout describing how to find accurate vaccine information on the internet and a handout on more common questions from vaccine hesitant parents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in parental attitude regarding vaccines
Time Frame: 6-8 weeks
|
Parental attitudes regarding vaccines will be assessed upon screening to determine the parental level of hesitancy regarding childhood vaccines.
We will will use the same survey questions again immediately after the intervention and at the 2 month visit to measure change in parental attitude.
We will also survey the control group at the 2 month check as well to compare attitude change without the intervention.
|
6-8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaccination rates of control and interventional groups
Time Frame: 6-8 weeks, 19 months
|
Vaccination rates will be compared between groups at both 2 months of age and 19 months of age.
|
6-8 weeks, 19 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
March 2, 2011
First Submitted That Met QC Criteria
June 28, 2011
First Posted (Estimate)
June 30, 2011
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
April 2, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- VA 1111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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