- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02151201
Impact of Influenza Vaccination in Pregnancy Video Education
May 30, 2014 updated by: Kenneth Goodman, MD, The Cleveland Clinic
Impact of Video Education on Influenza Vaccination Rate in Pregnancy
We evaluated the impact of viewing an educational video about influenza vaccination in pregnancy just prior to a routine prenatal visit on vaccination health beliefs and vaccination rate.
We hypothesized that the video would positively impact both vaccination health beliefs and vaccination rate compared to a control video.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We studied the impact of influenza in pregnancy video education that was developed by the CDC and currently available to the public on the internet.
We looked to see if viewing the video just prior to a routine scheduled prenatal visit could positively influence health beliefs regarding vaccination and improve the rate of vaccination that day.
Patients were randomized to view the intervention video or a control video of similar length about hand washing.
Pre visit and post visit questionnaires were given about vaccination health beliefs.
We also asked if the shot had been recommended by the physician.
One month after the visit, we used a structured phone interview to gather additional information regarding why participants who had not been vaccinated made that choice.
Study Type
Interventional
Enrollment (Actual)
105
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
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- pregnant
- English as primary language
- scheduled for a routine prenatal visit
- no documented influenza vaccination 2013-2014
Exclusion Criteria:
- Cleveland Clinic Employee
- high risk pregnancy
- allergy to eggs
- allergy to influenza vaccination
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Influenza vaccination video education
|
Influenza vaccination video education
|
Placebo Comparator: Hand Washing video education
Hand Washing vaccination video education
|
Hand washing video education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influenza Vaccination Rate
Time Frame: day of the prenatal visit
|
The electronic medical record was used to establish if patients were vaccinated the day of their prenatal visit.
|
day of the prenatal visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influenza Vaccination in Pregnancy Health Beliefs
Time Frame: day of the prenatal visit
|
day of the prenatal visit
|
|
Influenza vaccination in pregnancy health beliefs
Time Frame: Day of the appointment
|
health beliefs regarding vaccination were tested on a 5 point likert-type scale before the video intervention and after the prenatal visit.
|
Day of the appointment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider recommendation to become vaccinated
Time Frame: day of the appointment
|
the post visit survey asked participants to recall if their physician had recommended that they get the flu shot that visit.
|
day of the appointment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth Goodman, MD, The Cleveland Clinic
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
November 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
May 28, 2014
First Submitted That Met QC Criteria
May 29, 2014
First Posted (Estimate)
May 30, 2014
Study Record Updates
Last Update Posted (Estimate)
June 2, 2014
Last Update Submitted That Met QC Criteria
May 30, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-1157
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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