Childhood Influenza VaccinationSKIPPNCT03307642
Evaluation of the School Kids Influenza Prevention Project
A study testing Text message notification in people with Childhood Influenza Vaccination and School-located Influenza Vaccination, run by University of Rochester at 1 site in United States.
Trial summary
Children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders. Read more about this study
- Who is it for?
- Ages 4 to 19 years
- Conditions the study is for
- Childhood Influenza Vaccination, School-located Influenza Vaccination
- What is being tested?
- Text message notification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,540 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 22 Dec 2017
- 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 4 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled in the urban school district
Who cannot join
- Attends a school in the urban district containing a school-based health center
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Evaluation of a Text Based Reminder Recall System to Increase Utilization of the School Kids Influenza Prevention Project and Increase Influenza Vaccination Rates in Monroe County, NY
Children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders.
- Being tested
- Text message notification
- Keywords
- Influenza vaccination rates, Respiratory Tract Diseases
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message notificationOther
Three text messages will be sent to 50% of the parents, scheduled around the standard methods of communication
| Study group | Role | What they receive |
|---|---|---|
| SLIV + usual communication | No intervention | Parents receive usual communication from school (paper consent packets \& automated voice mails) about SLIV |
| SLIV + usual communication + text | Active comparator | Parents receive usual communication from school (paper consent packets \& automated voice mails) about SLIV plus a series of text messages informing them about the usual communication for SLIV Receives: Other: Text message notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccination status
Vaccination status for the 2017/2018 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
Measured: Through January, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start4 Dec 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Influenza VaccinationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Model description
- SLIV will be offered at all schools in an urban school district. Students will be randomized into either SLIV + standard communication about SLIV or SLIV + standard communication + text message reminders.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Stanley J Schaffer, MD, University of Rochester
- Investigators
- Stanley Schaffer, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307642
- Sponsor's protocol ID
- Version 3.01
- Acronym
- SKIPP
- Status last verified
- Mar 2018
- First submitted
- 5 Oct 2017
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Text Based Reminder Recall System to Increase Utilization of the School Kids Influenza Prevention Project and Increase Influenza Vaccination Rates in Monroe County, NY
- ClinicalTrials.gov ID
- NCT03307642
- Acronym / sponsor ID
- SKIPP / Version 3.01
- Keywords
- Influenza vaccination rates, Respiratory Tract Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,540 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 12 Oct 2017 (actual)
- 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.
Children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- SLIV will be offered at all schools in an urban school district. Students will be randomized into either SLIV + standard communication about SLIV or SLIV + standard communication + text message reminders.
| Arm | Type | Receives |
|---|---|---|
| SLIV + usual communication | No intervention | –Parents receive usual communication from school (paper consent packets \& automated voice mails) about SLIV |
| SLIV + usual communication + text | Active comparator | Other: Text message notificationParents receive usual communication from school (paper consent packets \& automated voice mails) about SLIV plus a series of text messages informing them about the usual communication for SLIV |
Who may qualify
- Ages
- 4 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled in the urban school district
Key exclusion criteria (1 listed)
- Attends a school in the urban district containing a school-based health center
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 |
|---|---|---|
| Text message notificationThree text messages will be sent to 50% of the parents, scheduled around the standard methods of communication | Other | SLIV + usual communication + text |
Primary outcome
Influenza vaccination status
Time frame: Through January, 2018
Vaccination status for the 2017/2018 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
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 12 Mar 2018.
- Individual participant dataSharing planned: No
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.
Stanley Schaffer, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message notification in people with Childhood Influenza Vaccination and School-located Influenza Vaccination, run by University of Rochester 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 1 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 12 Mar 2018. 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?
Influenza vaccination status (time frame: Through January, 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2018.