InfluenzaF2TNCT03287830
Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine
A study testing Text message influenza vaccine reminders in people with Influenza and Vaccination, run by Columbia University at 3 sites in United States.
Trial summary
This multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network. Read more about this study
- Who is it for?
- Ages 6 months to 8 years
- Conditions the study is for
- Influenza, Vaccination
- What is being tested?
- Text message influenza vaccine reminders
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,105 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Oct 2017to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parenting adult (or legal guardian) of a child that:
- is between 6 months through 8 years at the time of enrollment (or the age for which 2 doses of influenza are recommended should Centers for Disease Control and Prevention (CDC) recommendations change)
- received 1st dose of influenza vaccine within last 7 days
- receives care at study site
- needs 2 doses of influenza vaccine that season as determined by their clinician at the study site
- plan to continue to receive care through April 30 of that season (to the best of their knowledge) (season 2017-18 only)
- Ability to speak and read English or Spanish
- Has a cell phone that has text message capability
Who cannot join
- Parenting adult of a child that:
- already enrolled in the study in this or the previous season
- will leave practice before end of season (April 30) (to their best knowledge) (2017-18 season only)
- Was told by a health care provider that child should not get the flu shot again due to an allergic reaction or anaphylaxis (2017-18 season only)
- Unable to speak and read English or speak and read Spanish
- Unable to receive or read text messages on their cell phone
Trial locations and contacts
3 sites in 1 country.
United States3 sites
American Academy of Pediatrics
Itasca, Illinois, 60143
Columbia University Medical Center
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Flu2Text: A Multi-Site Study Assessing Text Message Reminders for 2nd Dose of Influenza Vaccine
This multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.
Read the detailed description
The study is to be conducted over the 1st season (September 2017-April 2018) as an effectiveness trial and the 2nd (September 2018-April 2019) as a replication study. This approach tests that the intervention effects can be replicated across seasons, during which the severity and incidence of influenza disease may vary. Eligible parents will have a child who received his/her first vaccine dose and is in need of 2 doses that season. Current recommendations require 2 doses for certain children 6 months through 8 years old. Within each practice site, parents will be randomized to receive either: 1) text message reminders embedded with influenza vaccine health-literacy promoting information, or 2) usual care. Randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language (Spanish, English).
- Conditions
- Influenza, Vaccination
- Being tested
- Text message influenza vaccine reminders
- Keywords
- text message, Short message service (SMS), mHealth
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message influenza vaccine remindersBehavioural
Text message reminders for second dose of influenza vaccination
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Text message influenza vaccine reminders Receives: Behavioral: Text message influenza vaccine reminders |
| Usual care | No intervention | Season 2017-18: Usual care has no text message Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year
Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year
Measured: Up to receipt of second dose, an average of 6 months
Secondary outcomes (1)
Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination
Receipt of second dose influenza vaccine by 42 days after first dose
Measured: Up to 42 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start6 Oct 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), American Academy of Pediatrics, Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Melissa Stockwell, Columbia University
- Investigators
- Melissa Stockwell, MD, MPH, Principal investigator, Columbia UniversityAlex Fiks, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287830
- Sponsor's protocol ID
- AAAR4101
- Other IDs
- R01HD086045-01A1
- Acronym
- F2T
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2017
- Last updated
- 15 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stockwell MS, Shone LP, Nekrasova E, Wynn C, Torres A, Griffith M, Shults J, Unger R, Ware LA, Kolff C, Harris D, Berrigan L, Montague H, Localio AR, Fiks AG. Text Message Reminders for the Second Dose of Influenza Vaccine for Children: An RCT. Pediatrics. 2022 Sep 1;150(3):e2022056967. doi: 10.1542/peds.2022-056967.
PubMed 35965283
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flu2Text: A Multi-Site Study Assessing Text Message Reminders for 2nd Dose of Influenza Vaccine
- ClinicalTrials.gov ID
- NCT03287830
- Acronym / sponsor ID
- F2T / AAAR4101
- Conditions
- Influenza, Vaccination
- Keywords
- text message, Short message service (SMS), mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,105 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), American Academy of Pediatrics, Children's Hospital of Philadelphia
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.
Detailed description
The study is to be conducted over the 1st season (September 2017-April 2018) as an effectiveness trial and the 2nd (September 2018-April 2019) as a replication study. This approach tests that the intervention effects can be replicated across seasons, during which the severity and incidence of influenza disease may vary. Eligible parents will have a child who received his/her first vaccine dose and is in need of 2 doses that season. Current recommendations require 2 doses for certain children 6 months through 8 years old. Within each practice site, parents will be randomized to receive either: 1) text message reminders embedded with influenza vaccine health-literacy promoting information, or 2) usual care. Randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language (Spanish, English).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Text message influenza vaccine remindersText message influenza vaccine reminders |
| Usual care | No intervention | –Season 2017-18: Usual care has no text message Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study. |
Who may qualify
- Ages
- 6 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Parenting adult (or legal guardian) of a child that:
- Ability to speak and read English or Spanish
- Has a cell phone that has text message capability
Key exclusion criteria (6 listed)
- Parenting adult of a child that:
- Was told by a health care provider that child should not get the flu shot again due to an allergic reaction or anaphylaxis (2017-18 season only)
- Unable to speak and read English or speak and read Spanish
- Unable to receive or read text messages on their cell phone
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 influenza vaccine remindersText message reminders for second dose of influenza vaccination | Behavioural | Intervention |
Primary outcome
Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year
Time frame: Up to receipt of second dose, an average of 6 months
Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year
1 secondary outcome
Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination
Time frame: Up to 42 days after first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35965283Stockwell MS, Shone LP, Nekrasova E, Wynn C, Torres A, Griffith M, Shults J, Unger R, Ware LA, Kolff C, Harris D, Berrigan L, Montague H, Localio AR, Fiks AG. Text Message Reminders for the Second Dose of Influenza Vaccine for Children: An RCT. Pediatrics. 2022 Sep 1;150(3):e2022056967. doi: 10.1542/peds.2022-056967.
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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.
Melissa Stockwell, MD, MPH principal investigator
Columbia University
Alex Fiks, MD, MSCE principal investigator
Children's Hospital of Philadelphia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message influenza vaccine reminders in people with Influenza and Vaccination, run by Columbia University at 3 sites 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 8 inclusion and 6 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 14 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year (time frame: Up to receipt of second dose, an average of 6 months). 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 NCT03287830, 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 15 Sep 2023.