FeverNCT02295007
Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging
A study testing text message in people with Fever and Wheezing, run by Columbia University at 3 sites in United States.
Trial summary
Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- What is being tested?
- text message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2014to May 2016
- 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- are 2 through 11years of age,
- have a visit at a study site anytime during the study period,
- receive first dose or second dose of LAIV4 or IIV in the season,
- the parent has a cell phone with text messaging capabilities, and
- the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.
Who cannot join
- presence of fever ≥100.4 at time of vaccination,
- administration of any antipyretic in the 6-hour period prior to vaccination,
- stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
- parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
- enrollee is a child >7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
- parent's inability to read and send text messages,
Show all 10Show fewer
- sibling already enrolled this season (OR cell phone # already used for another child)
- chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma),
- current asthma exacerbation, or exacerbation in the last 2 weeks
- use of oral or other systemic steroid within the last 2 weeks
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
Boston Medical Center
Boston, Massachusetts
Columbia University
New York, New York, 10032
About this study
Official title: Pilot Study to Assess Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging (2014-2015 Season)
Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.
- Being tested
- text message
- Medical subject headings
- Fever, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text messageBehavioural
| Study group | Role | What they receive |
|---|---|---|
| text message | Other | all families will receive text messages to which they can respond to report symptoms Receives: Behavioral: text message |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility reporting respiratory symptom
Response rates to text messages regarding wheezing, cough or chest tightness symptoms
Measured: days 0-42 days post-vaccination
Secondary outcomes (1)
feasibility reporting fever
Response rates to text messages regarding temperature
Measured: days 0-7 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2016
- Study completionMay 2016
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 FeverStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Boston Medical Center
- Responsible party
- Principal investigator, Melissa Stockwell, Columbia University
- Investigators
- Melissa Stockwell, MD MPH, Principal investigator, Columbia UniversityPhilip LaRussa, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295007
- Sponsor's protocol ID
- AAAO5253
- Status last verified
- May 2016
- First submitted
- 17 Nov 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P. A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging. Vaccine. 2017 Dec 15;35(50):6941-6948. doi: 10.1016/j.vaccine.2017.10.073. Epub 2017 Oct 28.
PubMed 29089191
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging (2014-2015 Season)
- ClinicalTrials.gov ID
- NCT02295007
- Acronym / sponsor ID
- AAAO5253
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Boston Medical Center
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Nov 2014 (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.
Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| text message | Other | Behavioral: text messageall families will receive text messages to which they can respond to report symptoms |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- are 2 through 11years of age,
- have a visit at a study site anytime during the study period,
- receive first dose or second dose of LAIV4 or IIV in the season,
- the parent has a cell phone with text messaging capabilities, and
- the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.
Key exclusion criteria (10 listed)
- presence of fever ≥100.4 at time of vaccination,
- administration of any antipyretic in the 6-hour period prior to vaccination,
- stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
- parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
- enrollee is a child >7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
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 | Behavioural | text message |
Primary outcome
feasibility reporting respiratory symptom
Time frame: days 0-42 days post-vaccination
Response rates to text messages regarding wheezing, cough or chest tightness symptoms
1 secondary outcome
feasibility reporting fever
Time frame: days 0-7 days post-vaccination
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 May 2016.
- Derived from this study: PubMed 29089191Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P. A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging. Vaccine. 2017 Dec 15;35(50):6941-6948. doi: 10.1016/j.vaccine.2017.10.073. Epub 2017 Oct 28.
Related trials for Fever
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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
Philip LaRussa, MD principal investigator
Columbia University
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 in people with Fever and Wheezing, 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 5 inclusion and 10 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 May 2016. 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?
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?
feasibility reporting respiratory symptom (time frame: days 0-42 days post-vaccination). 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 NCT02295007, 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 12 May 2016.