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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00812110
First received: December 18, 2008
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Influenza
Drug: Influenzae vaccine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • Number of Participants Who Received Influenza Vaccine. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination


Secondary Outcome Measures:
  • Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population? [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Number of participants who received influenza vaccine the prior year.


Enrollment: 336
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Influenzae vaccine
    0.5 mL Deltoid Intramuscular Injection X 1
    Other Name: Fluzone
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812110

Locations
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Peter C White, MD Akron Children's Hospital
  More Information

No publications provided

Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00812110     History of Changes
Other Study ID Numbers: 081105
Study First Received: December 18, 2008
Results First Received: October 31, 2011
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
Influenza prevention

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014