Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
1 other identifier
interventional
336
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
January 23, 2013
CompletedJanuary 23, 2013
December 1, 2012
9 months
December 18, 2008
October 31, 2011
December 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Received Influenza Vaccine.
Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination
1 hour
Secondary Outcomes (1)
Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?
16 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akron Children's Hospital
Akron, Ohio, 44308, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Exclusively urban,lower socioeconomic status population limits external generalizability. Study was uncontrolled; historical controls were referenced instead. Baseline vaccination rates were self-reported. Possible bias in at-risk determination.
Results Point of Contact
- Title
- P. Cooper White, M.D.
- Organization
- Akron Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Peter C White, MD
Akron Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 19, 2008
Study Start
December 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
January 23, 2013
Results First Posted
January 23, 2013
Record last verified: 2012-12