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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD086045-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| American Academy of Pediatrics | OTHER |
| Children's Hospital of Philadelphia | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text message influenza vaccine reminders | Behavioral | Text message reminders for second dose of influenza vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to receipt of second dose, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 42 days after first dose |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Stockwell, MD, MPH | Columbia University | Principal Investigator |
| Alex Fiks, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Academy of Pediatrics | Itasca | Illinois | 60143 | United States | ||
| Columbia University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35965283 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Text message influenza vaccine reminders Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination |
| FG001 | Usual Care | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Text message influenza vaccine reminders Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Up to receipt of second dose, an average of 6 months |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Text message influenza vaccine reminders Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Stockwell | Columbia University | 2123425732 | mss2112@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2019 | Nov 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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The care provider, primary statistician and analyst will be blinded to participant status.
| New York |
| New York |
| 10032 |
| United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Preferred Language for Texting | Count of Participants | Participants |
|
|
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| Secondary | 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 | Posted | Count of Participants | Participants | Up to 42 days after first dose |
|
|
|
| 0 |
| 1,044 |
| 0 |
| 1,044 |
| 0 |
| 1,044 |
| EG001 | Usual Care | 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. | 0 | 1,042 | 0 | 1,042 | 0 | 1,042 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |