VaccinationNCT01199666
Text Message Reminder-Recalls For Early Childhood Vaccination
A study testing Text message in people with Vaccination, run by Columbia University at 1 site in United States.
Trial summary
Although the investigators have reached the Healthy People 2010 goal of 80% coverage among U.S. children 19-35 months of age for the primary immunization series, 20% of children still remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of vaccine preventable disease persist. Read more about this study
- Who is it for?
- Ages 9 months to 50 years
- Conditions the study is for
- Vaccination
- What is being tested?
- Text message
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,586 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 2013
- 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 9 months to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parents of child >9 months to 25 months
- Child with at least one visit to one of the participating clinical sites in the previous 12 months
- Parental cell phone number recorded in the registration system
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Text 4 Health-Kids: Text Message Reminder-Recalls For Early Childhood Vaccination
Although the investigators have reached the Healthy People 2010 goal of 80% coverage among U.S. children 19-35 months of age for the primary immunization series, 20% of children still remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of vaccine preventable disease persist. Immunization reminder-recalls have been shown to be successful, but have been limited by the ability to identify and reach large target populations in a real-time, automated fashion. Reminder-recalls via text message may offer an innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a cell phone. Prior research by our team suggests that text messages reminder recalls may be an effective tool to remind parents about their children's vaccines. In this study, the investigators will demonstrate the effectiveness of tailored text message appointment and immunization reminders linked to a well-established and functional immunization registry to increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The investigators will target parents of young children from an underserved population that is primarily Latino, with low socioeconomic status.
- Conditions
- Vaccination
- Being tested
- Text message
- Keywords
- Underimmunization, text message, vaccination, Underimmunization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messageOther
text message appointment and immunization reminders
| Study group | Role | What they receive |
|---|---|---|
| Text message reminders | Experimental | Not described Receives: Other: Text message |
| standard of care for MMR, letter reminder for Hep A | Active comparator | MMR: automated phone call appointment reminder Hep A: recall letter, automated phone call appointment reminder Receives: Other: Text message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of MMR1
Measured: by 13 and 16 months of age
Secondary outcomes (2)
Timeliness of HepA vaccination post-recall
Measured: 4,12, 24 weeks
Attendance at appointments
Measured: after appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Stockwell, MD, MPH, Columbia University
- Investigators
- Melissa S Stockwell, MD MPH, Principal investigator, Columbia UniversityAnnika Hofstetter, MD PhD MPH, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199666
- Sponsor's protocol ID
- AAAF4263
- Status last verified
- Jul 2014
- First submitted
- 9 Sep 2010
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text 4 Health-Kids: Text Message Reminder-Recalls For Early Childhood Vaccination
- ClinicalTrials.gov ID
- NCT01199666
- Acronym / sponsor ID
- AAAF4263
- Conditions
- Vaccination
- Keywords
- Underimmunization, text message, vaccination, Underimmunization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,586 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Sep 2010 (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.
Although the investigators have reached the Healthy People 2010 goal of 80% coverage among U.S. children 19-35 months of age for the primary immunization series, 20% of children still remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of vaccine preventable disease persist. Immunization reminder-recalls have been shown to be successful, but have been limited by the ability to identify and reach large target populations in a real-time, automated fashion. Reminder-recalls via text message may offer an innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a cell phone. Prior research by our team suggests that text messages reminder recalls may be an effective tool to remind parents about their children's vaccines. In this study, the investigators will demonstrate the effectiveness of tailored text message appointment and immunization reminders linked to a well-established and functional immunization registry to increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The investigators will target parents of young children from an underserved population that is primarily Latino, with low socioeconomic status.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text message reminders | Experimental | Other: Text message |
| standard of care for MMR, letter reminder for Hep A | Active comparator | Other: Text messageMMR: automated phone call appointment reminder Hep A: recall letter, automated phone call appointment reminder |
Who may qualify
- Ages
- 9 months to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Parents of child >9 months to 25 months
- Child with at least one visit to one of the participating clinical sites in the previous 12 months
- Parental cell phone number recorded in the registration system
Key exclusion criteria (0 listed)
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 messagetext message appointment and immunization reminders | Other | Text message reminders, standard of care for MMR, letter reminder for Hep A |
Primary outcome
Receipt of MMR1
Time frame: by 13 and 16 months of age
2 secondary outcomes
Timeliness of HepA vaccination post-recall
Time frame: 4,12, 24 weeks
Attendance at appointments
Time frame: after appointment
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 25 Jul 2014.
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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 S Stockwell, MD MPH principal investigator
Columbia University
Annika Hofstetter, MD PhD MPH study director
Columbia University
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 in people with Vaccination, run by Columbia University 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 3 inclusion and 0 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 25 Jul 2014. 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?
Receipt of MMR1 (time frame: by 13 and 16 months of age). 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 25 Jul 2014.