ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the School Kids Influenza Prevention Project (SKIPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03307642
Recruitment Status : Completed
First Posted : October 12, 2017
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Stanley J Schaffer, MD, University of Rochester

Brief 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.

Condition or disease Intervention/treatment Phase
Childhood Influenza Vaccination School-located Influenza Vaccination Other: Text message notification Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: SLIV + usual communication
Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV
Active Comparator: SLIV + usual communication + text
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
Other: Text message notification
Three text messages will be sent to 50% of the parents, scheduled around the standard methods of communication



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Enrolled in the urban school district

Exclusion Criteria:

- Attends a school in the urban district containing a school-based health center


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307642


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
University of California, Los Angeles
Investigators
Principal Investigator: Stanley Schaffer, MD University of Rochester

Responsible Party: Stanley J Schaffer, MD, Primary Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT03307642     History of Changes
Other Study ID Numbers: Version 3.01
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stanley J Schaffer, MD, University of Rochester:
Influenza vaccination rates
Respiratory Tract Diseases

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases