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CompletedNCT01431183Updated Sep 9, 2011

Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

An interventional study of Mailed influenza vaccination reminder notice in Seasonal Influenza Vaccination, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 24 Months to 60 Months. Per ClinicalTrials.gov, last updated 2011-09-09.

Sponsored by University of Michigan · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
3,618
Allocation
Randomized
Ages
24 Months to 60 Months
Sex
All
01

Study summary

The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.

02

Conditions studied

  • Seasonal Influenza Vaccination

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Keywords

  • influenza
  • vaccine
  • reminder / recall
  • immunization registry
  • immunization information systems
03

In context

Influenza, Human

2,265 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's enrollment of 3,618 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

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Lead sponsor

University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • children, 24-60 months
  • current or previous enrollment in Medicaid (Michigan)
  • presence of at least 1 chronic condition, as indicated by the Michigan Care Improvement Registry (MCIR)
  • resident of Kalamazoo, Ottawa, or Kent counties (Michigan)

Exclusion criteria

Exclusion Criteria:

  • receipt of influenza prior to notification date
  • ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
3,618 participants (actual)

Study arms

  • Active comparator
    mailed reminder notice

    Seasonal influenza vaccination reminder sent by postal mail

    Behavioral: Mailed influenza vaccination reminder notice

  • No intervention
    No reminder notice

    No seasonal influenza vaccination reminder sent by postal mail

Interventions

  • BehavioralMailed influenza vaccination reminder notice

    Influenza vaccination reminder sent by postal mail

06

What researchers measure

Primary outcomes

  1. seasonal influenza vaccination

    Receipt of 1 or more dose of seasonal influenza vaccine, either trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV)

    Time frame: up to 4 months following reminder notification

Secondary outcomes

  1. invalid mailing address

    Postal mailing address determined to be invalid for mail delivery, either by physical return of mailed reminder notification, or through the United States Postal Service's National Change of Address (NCOA) process

    Time frame: up to 4 months following reminder notification

07

Study locations

1 site
  • University of Michigan, Child Health Evaluation and Research Unit
    Ann Arbor, Michigan 48109, United States
08

References and documents

Publications

  • Dombkowski KJ, Harrington LB, Dong S, Clark SJ. Seasonal influenza vaccination reminders for children with high-risk conditions: a registry-based randomized trial. Am J Prev Med. 2012 Jan;42(1):71-5. doi: 10.1016/j.amepre.2011.09.028. PubMed 22176850 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01431183
Lead sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
Responsible party
Kevin Dombkowski (Research Associate Professor, University of Michigan) — Principal investigator
First posted
Sep 9, 2011
Start date
Oct 2008
Primary completion
Feb 2009
Completion
Dec 2010
Last update
Sep 9, 2011

Study contacts

Kevin J Dombkowski, DrPH, MS
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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