Impact of Explanation Given to Parents on Rate of Post-partum Influenza Vaccination

February 13, 2017 updated by: Hillel Yaffe Medical Center
The aim of this study is to determine whether an explanation to parents for the need for post-partum influenza vaccination will influence their compliance.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

208

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

      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All parents discharged from well-baby nursery

Exclusion Criteria:

-

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Explanation
Explanation to parents on importance of post-partum influenza vaccination on health of their newborn infant with a follow-up questionnaire to determine rate of vaccination
Oral and written explanation on importance of post-partum influenza vaccination for the health of their newborn infant
Follow-up questionnaire to determine whether participants have receive post-partum vaccination
Active Comparator: No explanation
No explanation will be given to parents but they will be followed-up with a questionnaire to determine rate of vaccination
Follow-up questionnaire to determine whether participants have receive post-partum vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of post-partum influenza vaccination
Time Frame: 2 months
Telephone questionnaire to parents to determine compliance with vaccination
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amit Hochberg, MD, Hillel Yaffe Medical Center

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 (Anticipated)

February 20, 2017

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HYMC104-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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