VaccinationNCT02231957
Text Message Vaccine Reminders for Adolescents With Chronic Medical Conditions
A study testing educational text message reminders and conventional text message reminders in people with Vaccination, run by Columbia University at 1 site in United States.
Trial summary
There are a growing number of adolescents with chronic medical conditions in the United States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination and annual influenza vaccination of all adolescents. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Vaccination
- What is being tested?
- educational text message reminders and conventional text message reminders
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jan 2017
- 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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent with
- adolescent aged 11-17 years;
- adolescent with ≥1 chronic medical condition;
- adolescent with clinic visit in last 12 months;
- cell phone number listed in hospital registration system
Who cannot join
- Parent who:
- does not speak English or Spanish;
- is unwilling to receive text message vaccine reminders;
- anticipates moving from area in coming 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032
About this study
There are a growing number of adolescents with chronic medical conditions in the United States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination is also recommended for certain high-risk patients. Limited studies suggest that vaccination coverage of this population remains sub-optimal. Text message vaccine reminder/recall has been shown to be effective in increasing uptake of select pediatric and adolescents vaccines, but has yet to be examined among patients with chronic medical conditions who may also face unique barriers to vaccination. This intervention aims to implement and evaluate the use of text message vaccine reminders among urban low-income minority adolescents with chronic medical conditions. This investigator-initiated study is supported in part by a grant from the Pfizer Medical Education Group.
- Conditions
- Vaccination
- Being tested
- educational text message reminders, conventional text message reminders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational text message remindersOther
Also called educational text message vaccine reminders, education-embedded text message vaccine reminders
conventional text message remindersOther
Also called conventional text message vaccine reminders
| Study group | Role | What they receive |
|---|---|---|
| educational text message reminders | Experimental | receipt of education-embedded text message vaccine reminders Receives: Other: educational text message reminders |
| conventional text message reminders | Active comparator | receipt of conventional text message vaccine reminders Receives: Other: conventional text message reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
Measured: 12 weeks after intervention start
Secondary outcomes (5)
Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
Measured: 4 weeks after intervention start
Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
Measured: 24 weeks after intervention start
Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
Measured: 4 weeks after intervention start
Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
Measured: 12 weeks after intervention start
Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
Measured: 24 weeks after intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJan 2017
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 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Annika Hofstetter, Columbia University
- Investigators
- Annika M Hofstetter, MD, PhD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231957
- Sponsor's protocol ID
- AAAM3756
- Status last verified
- Jan 2017
- First submitted
- 15 Aug 2014
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hofstetter AM, Barrett A, Camargo S, Rosenthal SL, Stockwell MS. Text message reminders for vaccination of adolescents with chronic medical conditions: A randomized clinical trial. Vaccine. 2017 Aug 16;35(35 Pt B):4554-4560. doi: 10.1016/j.vaccine.2017.07.022. Epub 2017 Jul 21.
PubMed 28736201
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Message Vaccine Reminders for Adolescents With Chronic Medical Conditions
- ClinicalTrials.gov ID
- NCT02231957
- Acronym / sponsor ID
- AAAM3756
- Conditions
- Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 Sep 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.
There are a growing number of adolescents with chronic medical conditions in the United States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination is also recommended for certain high-risk patients. Limited studies suggest that vaccination coverage of this population remains sub-optimal. Text message vaccine reminder/recall has been shown to be effective in increasing uptake of select pediatric and adolescents vaccines, but has yet to be examined among patients with chronic medical conditions who may also face unique barriers to vaccination. This intervention aims to implement and evaluate the use of text message vaccine reminders among urban low-income minority adolescents with chronic medical conditions. This investigator-initiated study is supported in part by a grant from the Pfizer Medical Education Group.
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 |
|---|---|---|
| educational text message reminders | Experimental | Other: educational text message remindersreceipt of education-embedded text message vaccine reminders |
| conventional text message reminders | Active comparator | Other: conventional text message remindersreceipt of conventional text message vaccine reminders |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parent with
- adolescent aged 11-17 years;
- adolescent with ≥1 chronic medical condition;
- adolescent with clinic visit in last 12 months;
- cell phone number listed in hospital registration system
Key exclusion criteria (4 listed)
- does not speak English or Spanish;
- is unwilling to receive text message vaccine reminders;
- anticipates moving from area in coming 12 months
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 |
|---|---|---|
| educational text message remindersAlso: educational text message vaccine reminders, education-embedded text message vaccine reminders | Other | educational text message reminders |
| conventional text message remindersAlso: conventional text message vaccine reminders | Other | conventional text message reminders |
Primary outcome
Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
Time frame: 12 weeks after intervention start
5 secondary outcomes
Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
Time frame: 4 weeks after intervention start
Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
Time frame: 24 weeks after intervention start
Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
Time frame: 4 weeks after intervention start
Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
Time frame: 12 weeks after intervention start
Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
Time frame: 24 weeks after intervention start
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 30 Jan 2017.
- Derived from this study: PubMed 28736201Hofstetter AM, Barrett A, Camargo S, Rosenthal SL, Stockwell MS. Text message reminders for vaccination of adolescents with chronic medical conditions: A randomized clinical trial. Vaccine. 2017 Aug 16;35(35 Pt B):4554-4560. doi: 10.1016/j.vaccine.2017.07.022. Epub 2017 Jul 21.
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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.
Annika M Hofstetter, MD, PhD, MPH principal investigator
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 educational text message reminders and conventional text message reminders 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 5 inclusion and 4 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 30 Jan 2017. 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?
Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s) (time frame: 12 weeks after intervention start). 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 NCT02231957, 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 30 Jan 2017.