Impact of Influenza Vaccination in Pregnancy Video Education
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Influenza vaccination video education
Hand washing video education
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring pregnancy vaccination influenza education
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Influenza vaccination video education
Hand Washing video education
Arm Description
Influenza vaccination video education
Hand Washing vaccination video education
Outcomes
Primary Outcome Measures
Influenza Vaccination Rate
The electronic medical record was used to establish if patients were vaccinated the day of their prenatal visit.
Secondary Outcome Measures
Influenza Vaccination in Pregnancy Health Beliefs
Influenza vaccination in pregnancy health beliefs
health beliefs regarding vaccination were tested on a 5 point likert-type scale before the video intervention and after the prenatal visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02151201
Brief Title
Impact of Influenza Vaccination in Pregnancy Video Education
Official Title
Impact of Video Education on Influenza Vaccination Rate in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
pregnancy vaccination influenza education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza vaccination video education
Arm Type
Experimental
Arm Description
Influenza vaccination video education
Arm Title
Hand Washing video education
Arm Type
Placebo Comparator
Arm Description
Hand Washing vaccination video education
Intervention Type
Behavioral
Intervention Name(s)
Influenza vaccination video education
Intervention Description
Influenza vaccination video education
Intervention Type
Behavioral
Intervention Name(s)
Hand washing video education
Intervention Description
Hand washing video education
Primary Outcome Measure Information:
Title
Influenza Vaccination Rate
Description
The electronic medical record was used to establish if patients were vaccinated the day of their prenatal visit.
Time Frame
day of the prenatal visit
Secondary Outcome Measure Information:
Title
Influenza Vaccination in Pregnancy Health Beliefs
Time Frame
day of the prenatal visit
Title
Influenza vaccination in pregnancy health beliefs
Description
health beliefs regarding vaccination were tested on a 5 point likert-type scale before the video intervention and after the prenatal visit.
Time Frame
Day of the appointment
Other Pre-specified Outcome Measures:
Title
Provider recommendation to become vaccinated
Description
the post visit survey asked participants to recall if their physician had recommended that they get the flu shot that visit.
Time Frame
day of the appointment
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Goodman, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Influenza Vaccination in Pregnancy Video Education
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