Childhood VaccinationNCT01770496
Age-Specific Strategies for Immunization Reminders and Recalls
A study testing Childhood vaccination reminder / recall notification in people with Childhood Vaccination, run by University of Michigan at 1 site in United States.
Trial summary
The objective of this study was to assess the relative effectiveness of reminder/recall strategies among children who live in an urban area targeting alternative age-specific milestones. Read more about this study
- Who is it for?
- Ages 7 to 19 months
- Conditions the study is for
- Childhood Vaccination
- What is being tested?
- Childhood vaccination reminder / recall notification
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,175 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 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 7 to 19 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7 and 19 month recall groups: children not up to date for at least one vaccination at the time of notification
- 12 month reminder group: 12 months of age at time of notification
- Hib vaccination series was not assessed due to a vaccine shortage
Who cannot join
- Children were ineligible for notifications if they were designated in the Michigan Care Improvement Registry (MCIR)as having died, documented previously as having moved out of the jurisdiction ("Moved or Gone Elsewhere" (MOGE)), opted out of MCIR by their parent, or if they had been previously mailed for MCIR reminder/recall activity in the prior 60 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Child Health Evaluation and Research (CHEAR) Unit
Ann Arbor, Michigan, 48109-5456
About this study
The objective of this study was to assess the relative effectiveness of reminder/recall strategies among children who live in an urban area targeting alternative age-specific milestones.
- Conditions
- Childhood Vaccination
- Being tested
- Childhood vaccination reminder / recall notification
- Keywords
- immunization, vaccination, immunization information system, immunization registry, reminder / recall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childhood vaccination reminder / recall notificationBehavioural
Also called Reminder / recall notifications sent by postal mail
| Study group | Role | What they receive |
|---|---|---|
| No reminder / recall notice | No intervention | No childhood vaccination reminder / recall notification sent. Stratified by age cohort of subjects: 7 month recall; 12 month reminder; 19 month recall |
| mailed reminder / recall notice | Experimental | Childhood vaccination reminder / recall notification sent by postal mail. Stratified by age cohort of subjects: 7 month recall; 12 month reminder; 19 month recall Receives: Behavioral: Childhood vaccination reminder / recall notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
new immunization doses
Receipt of 1 or more childhood vaccinations with administration date following reminder notification date
Measured: within 60 days of reminder notification
Secondary outcomes (3)
Cost of vaccination reminder
Estimated personnel costs to generate reminder notifications, print, fold / stuff envelopes and follow up on undeliverable notifications
Measured: During the time of reminder notification preparation and mailing and approximately 1 month following mailing
historical immunization doses
One or more vaccination recorded with the date of administration prior to the reminder notification date
Measured: within 60 days of reminder notification
waived doses
One or more immunization waiver (non-administration) recorded with the date following the date of reminder notification
Measured: within 60 days of reminder notification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionSep 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 Childhood 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
- 10,175 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, Child Health Evaluation and Research (CHEAR) Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770496
- Sponsor's protocol ID
- U01IP000088-01
- Status last verified
- Jan 2013
- First submitted
- 15 Jan 2013
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dombkowski KJ, Costello LE, Harrington LB, Dong S, Kolasa M, Clark SJ. Age-specific strategies for immunization reminders and recalls: a registry-based randomized trial. Am J Prev Med. 2014 Jul;47(1):1-8. doi: 10.1016/j.amepre.2014.02.009. Epub 2014 Apr 18.
PubMed 24750973
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Specific Strategies for Immunization Reminders and Recalls
- ClinicalTrials.gov ID
- NCT01770496
- Acronym / sponsor ID
- U01IP000088-01
- Conditions
- Childhood Vaccination
- Keywords
- immunization, vaccination, immunization information system, immunization registry, reminder / recall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,175 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Jan 2013 (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 relative effectiveness of reminder/recall strategies among children who live in an urban area targeting alternative age-specific milestones.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No reminder / recall notice | No intervention | –No childhood vaccination reminder / recall notification sent. Stratified by age cohort of subjects: 7 month recall; 12 month reminder; 19 month recall |
| mailed reminder / recall notice | Experimental | Behavioral: Childhood vaccination reminder / recall notificationChildhood vaccination reminder / recall notification sent by postal mail. Stratified by age cohort of subjects: 7 month recall; 12 month reminder; 19 month recall |
Who may qualify
- Ages
- 7 to 19 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 7 and 19 month recall groups: children not up to date for at least one vaccination at the time of notification
- 12 month reminder group: 12 months of age at time of notification
- Hib vaccination series was not assessed due to a vaccine shortage
Key exclusion criteria (1 listed)
- Children were ineligible for notifications if they were designated in the Michigan Care Improvement Registry (MCIR)as having died, documented previously as having moved out of the jurisdiction ("Moved or Gone Elsewhere" (MOGE)), opted out of MCIR by their parent, or if they had been previously mailed for MCIR reminder/recall activity in the prior 60 days.
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 |
|---|---|---|
| Childhood vaccination reminder / recall notificationAlso: Reminder / recall notifications sent by postal mail | Behavioural | mailed reminder / recall notice |
Primary outcome
new immunization doses
Time frame: within 60 days of reminder notification
Receipt of 1 or more childhood vaccinations with administration date following reminder notification date
3 secondary outcomes
Cost of vaccination reminder
Time frame: During the time of reminder notification preparation and mailing and approximately 1 month following mailing
historical immunization doses
Time frame: within 60 days of reminder notification
waived doses
Time frame: within 60 days of 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 17 Jan 2013.
- Derived from this study: PubMed 24750973Dombkowski KJ, Costello LE, Harrington LB, Dong S, Kolasa M, Clark SJ. Age-specific strategies for immunization reminders and recalls: a registry-based randomized trial. Am J Prev Med. 2014 Jul;47(1):1-8. doi: 10.1016/j.amepre.2014.02.009. Epub 2014 Apr 18.
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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, Child Health Evaluation and Research (CHEAR) Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Childhood vaccination reminder / recall notification in people with Childhood 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 3 inclusion and 1 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 17 Jan 2013. 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?
new immunization doses (time frame: within 60 days of 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 NCT01770496, 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 17 Jan 2013.