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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02151201
Other study ID # 13-1157
Secondary ID
Status Completed
Phase N/A
First received May 28, 2014
Last updated May 30, 2014
Start date November 2013
Est. completion date January 2014

Study information

Verified date May 2014
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Influenza vaccination video education
Influenza vaccination video education
Hand washing video education
Hand washing video education

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Provider recommendation to become vaccinated 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 No
Primary Influenza Vaccination Rate The electronic medical record was used to establish if patients were vaccinated the day of their prenatal visit. day of the prenatal visit No
Secondary Influenza Vaccination in Pregnancy Health Beliefs day of the prenatal visit No
Secondary 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. Day of the appointment No
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