Seasonal Influenza VaccinationNCT01431183
Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
A study testing Mailed influenza vaccination reminder notice in people with Seasonal Influenza Vaccination, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 60 months
- Conditions the study is for
- Seasonal Influenza Vaccination
- What is being tested?
- Mailed influenza vaccination reminder notice
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,618 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- receipt of influenza prior to notification date
- ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Child Health Evaluation and Research Unit
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- Seasonal Influenza Vaccination
- Being tested
- Mailed influenza vaccination reminder notice
- Keywords
- influenza, vaccine, reminder / recall, immunization registry, immunization information systems
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed influenza vaccination reminder noticeBehavioural
Influenza vaccination reminder sent by postal mail
| Study group | Role | What they receive |
|---|---|---|
| mailed reminder notice | Active comparator | Seasonal influenza vaccination reminder sent by postal mail Receives: Behavioral: Mailed influenza vaccination reminder notice |
| No reminder notice | No intervention | No seasonal influenza vaccination reminder sent by postal mail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: up to 4 months following reminder notification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Influenza VaccinationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Kevin Dombkowski, University of Michigan
- Investigators
- Kevin J Dombkowski, DrPH, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431183
- Sponsor's protocol ID
- 5U01IP000132
- Status last verified
- Sep 2011
- First submitted
- 6 Sep 2011
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
- ClinicalTrials.gov ID
- NCT01431183
- Acronym / sponsor ID
- 5U01IP000132
- Conditions
- Seasonal Influenza Vaccination
- Keywords
- influenza, vaccine, reminder / recall, immunization registry, immunization information systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,618 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mailed reminder notice | Active comparator | Behavioral: Mailed influenza vaccination reminder noticeSeasonal influenza vaccination reminder sent by postal mail |
| No reminder notice | No intervention | –No seasonal influenza vaccination reminder sent by postal mail |
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- receipt of influenza prior to notification date
- ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mailed influenza vaccination reminder noticeInfluenza vaccination reminder sent by postal mail | Behavioural | mailed reminder notice |
Primary outcome
seasonal influenza vaccination
Time frame: up to 4 months following reminder notification
Receipt of 1 or more dose of seasonal influenza vaccine, either trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV)
1 secondary outcome
invalid mailing address
Time frame: up to 4 months following reminder notification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
- Derived from this study: PubMed 22176850Dombkowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin J Dombkowski, DrPH, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mailed influenza vaccination reminder notice in people with Seasonal Influenza Vaccination, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seasonal influenza vaccination (time frame: up to 4 months following reminder notification). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01431183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.