VaccinationNCT02907645
Influenza Vaccine Randomized Educational Trial: Adult
A study testing Local educational information and National educational information in people with Vaccination and Influenza, run by Columbia University at 1 site in United States.
Trial summary
Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Vaccination, Influenza
- What is being tested?
- Local educational information and National educational information
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2016to 1 Jun 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- visit to study site at time of intervention
Who cannot join
- prior receipt of influenza vaccine that season
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate patients, public health entities and physicians give informational handouts in various forms.
However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. The purpose of this study is to compare the effectiveness of pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational message on patient's receipt of the influenza vaccine. These results will help to understand the relationship between patient education and the intent to vaccinate and receipt of the influenza vaccine as well as to optimize educational information given to patients regarding the influenza vaccine.
- Conditions
- Vaccination, Influenza
- Being tested
- Local educational information, National educational information
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local educational informationBehavioural
Adult patients in this arm receive educational information regarding influenza vaccination based on local data
National educational informationBehavioural
Adult patients in this arm receive educational information regarding influenza vaccination based on national data
| Study group | Role | What they receive |
|---|---|---|
| Local educational | Experimental | Adult patients in this arm receive educational information regarding influenza vaccination based on local data Receives: Behavioral: Local educational information |
| National educational | Experimental | Adult patients in this arm receive educational information regarding influenza vaccination based on national data Receives: Behavioral: National educational information |
| Usual care | No intervention | No educational information other than provided as usual care by health care providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who receive influenza vaccination on day of intervention
Receipt of influenza vaccination on the day of the educational intervention
Measured: Day 0
Secondary outcomes (1)
Number of participants who receive Influenza vaccination by the end of the influenza vaccine season
Receipt of influenza vaccination by April 2017
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start6 Oct 2016
- Primary completion31 May 2017
- Study completion1 Jun 2017
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
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Stockwell, Columbia University
- Investigators
- Melissa Stockwell, MD MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907645
- Sponsor's protocol ID
- AAAR0289
- Status last verified
- Jul 2017
- First submitted
- 8 Sep 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccine Randomized Educational Trial: Adult
- ClinicalTrials.gov ID
- NCT02907645
- Acronym / sponsor ID
- AAAR0289
- Conditions
- Vaccination, Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 20 Sep 2016 (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.
Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate patients, public health entities and physicians give informational handouts in various forms.
However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. The purpose of this study is to compare the effectiveness of pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational message on patient's receipt of the influenza vaccine. These results will help to understand the relationship between patient education and the intent to vaccinate and receipt of the influenza vaccine as well as to optimize educational information given to patients regarding the influenza vaccine.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local educational | Experimental | Behavioral: Local educational informationAdult patients in this arm receive educational information regarding influenza vaccination based on local data |
| National educational | Experimental | Behavioral: National educational informationAdult patients in this arm receive educational information regarding influenza vaccination based on national data |
| Usual care | No intervention | –No educational information other than provided as usual care by health care providers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- visit to study site at time of intervention
Key exclusion criteria (1 listed)
- prior receipt of influenza vaccine that season
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 |
|---|---|---|
| Local educational informationAdult patients in this arm receive educational information regarding influenza vaccination based on local data | Behavioural | Local educational |
| National educational informationAdult patients in this arm receive educational information regarding influenza vaccination based on national data | Behavioural | National educational |
Primary outcome
Number of participants who receive influenza vaccination on day of intervention
Time frame: Day 0
Receipt of influenza vaccination on the day of the educational intervention
1 secondary outcome
Number of participants who receive Influenza vaccination by the end of the influenza vaccine season
Time frame: Up to 7 months
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 27 Jul 2017.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local educational information and National educational information in people with Vaccination and Influenza, 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 1 inclusion and 1 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 27 Jul 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?
Number of participants who receive influenza vaccination on day of intervention (time frame: Day 0). 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 27 Jul 2017.