Trial Outcomes & Findings for Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home (NCT NCT00812110)

NCT ID: NCT00812110

Last Updated: 2013-01-23

Results Overview

Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 336 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2013-01-23

Participant Flow

During the 2008-2009 influenza season, 474 caregivers were approached. 292 agreed to participate,and had not received influenza vaccine.

Participant milestones

Measure	Caregivers Caregivers of children at high risk, per CDC definitions, of complications of influenza.
Overall Study STARTED	292
Overall Study COMPLETED	292
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Caregivers n=292 Participants Caregivers of children at high risk, per CDC definitions, of complications of influenza.
Age Continuous	30.5 years STANDARD_DEVIATION 10.6 • n=93 Participants
Sex: Female, Male Female	235 Participants n=93 Participants
Sex: Female, Male Male	57 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	171 Participants n=93 Participants
Race (NIH/OMB) White	100 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=93 Participants
Region of Enrollment United States	292 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 hour

Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination

Outcome measures

Measure	Caregivers n=292 Participants Caregivers of children at risk for complications of influenza
Number of Participants Who Received Influenza Vaccine.	250 participants

SECONDARY outcome

Timeframe: 16 months

Number of participants who received influenza vaccine the prior year.

Outcome measures

Measure	Caregivers n=292 Participants Caregivers of children at risk for complications of influenza
Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?	69 participants

Adverse Events

Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

P. Cooper White, M.D.

Akron Children's Hospital

Phone: 330-543-8530

Email: CWhite@chmca.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place