Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

Phase 4

Completed

• Conditions: Influenza

• Registration Number: NCT00812110
• Lead Sponsor: Akron Children's Hospital

Brief Summary

We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-18
• Study First Posted: 2008-12-19
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2011-10-31
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-13
• Last Update Submitted: 2012-12-13
• Results First Posted: 2013-01-23
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• Parents or caregiver adults who accompany at-risk children to a Pediatric Care outpatient clinic appointment. High risk children are defined as those 0 to 5 years of age, or who have any of the following diagnoses:

  • Sickle cell disease
  • Asthma
  • Cystic fibrosis
  • Chronic renal disease
  • Congenital heart disease
  • Cancer
  • Any immunodeficiency

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Exclusion Criteria

• Caregivers of children residing in group homes
• Persons whose children do not meet the Center for Disease Control (CDC) definition of high-risk
• Persons who have had allergic reactions to influenza vaccination or any other vaccination in the past
• Persons who are allergic to eggs or egg products
• Persons who are allergic to thimerosol
• Previous diagnosis of Guillain-Barré syndrome (GBS)
• Persons who are moderately to severely ill at the time the vaccination is to be given

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Received Influenza Vaccine.	1 hour	Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination

Secondary Outcome Measures

Name	Time	Method
Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?	16 months	Number of participants who received influenza vaccine the prior year.

Trial Locations

Locations (1)

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States