Influenza VaccinationNCT01009645
The Effect of Fact Versus Myth Messages on Receipt of Influenza Vaccination
A study testing Fact Only Education Message, Fact and Myth Educational Message and Fact, Myth, Why Educational Message in people with Influenza Vaccination, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Influenza Vaccination
- What is being tested?
- Fact Only Education Message, Fact and Myth Educational Message and Fact, Myth, Why Educational Message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have a scheduled appointment at least 6 weeks in advance in either the GIM or Geriatrics clinics at NMFF.
- Participant must be a patient of Northwestern Medical Faculty Foundation.
- Participant does not intend to receive the influenza vaccine.
Who cannot join
- Participant has a diagnosis of Alzheimer's Disease or Dementia
- Participant has received an influenza vaccination during either the last influenza season or the current.
- The scheduled visit is the participant's first time being seen by this doctor (appointment is to establish care in the clinic).
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Faculty Foundation General Internal Medicine and Geriatric Clinics
Chicago, Illinois, 60611
About this study
The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.
- Conditions
- Influenza Vaccination
- Being tested
- Fact Only Education Message, Fact and Myth Educational Message, Fact, Myth, Why Educational Message, Control Educational Message
- Keywords
- education, vaccination, preventive service, Prevention & Control
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fact Only Education MessageBehavioural
Also called Fact Only
Participants randomized to this intervention will receive an educational brochure listing the facts of the influenza vaccine.
Fact and Myth Educational MessageBehavioural
Also called Fact & Myth
Participants randomized to this intervention will receive an educational brochure listing the facts and myths of the influenza vaccine.
Fact, Myth, Why Educational MessageBehavioural
Also called Fact, Myth, Why
Participants randomized to this intervention will receive an educational brochure listing the facts, myths, and refutation of the myths of the influenza vaccine.
Control Educational MessageBehavioural
Also called Control
Participants randomized to this intervention will receive an educational brochure created and used by the CDC in a previous influenza season.
| Study group | Role | What they receive |
|---|---|---|
| Fact Only | Experimental | The educational message used will contain facts only. Receives: Behavioral: Fact Only Education Message |
| Fact and Myth | Experimental | The educational material seen by this arm will contain facts and myths only. Receives: Behavioral: Fact and Myth Educational Message |
| Fact, Myth, Why | Experimental | The educational material seen by this arm will contain myths, facts, and refutations of the myths. Receives: Behavioral: Fact, Myth, Why Educational Message |
| Control | Placebo comparator | This arm will receive fact/myth educational materials originally developed and used by the CDC. Receives: Behavioral: Control Educational Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza Vaccination
The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit.
Measured: 1 week following randomization
Secondary outcomes (1)
Recall Accuracy
Participants were given 8 statements about the flu/flu shot and asked to recall if they had seen the statement on the message they received via FedEx. Participants responded that statement had been "presented as a fact," "presented as a myth," "presented, but I don't recall if it was a fact or a myth," or "not presented." Participants scored 1 for each correct answer; 0 for each incorrect answer or for response "I don't recall." Recall accuracy was calculated among each message format, range for recall accuracy was 0 - 8 with 0 indicating no correct answers and 8 representing 100% accuracy. Thus units of measurement are "units on a scale" to represent participant scores out of 8 on the recall items.
Measured: 1 week following receipt of message
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza VaccinationStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009645
- Sponsor's protocol ID
- Fact versus Myth Messages
- Other IDs
- 1R21AG031470-01
- Status last verified
- Oct 2023
- First submitted
- 6 Nov 2009
- Last updated
- 30 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fact Versus Myth Messages on Receipt of Influenza Vaccination
- ClinicalTrials.gov ID
- NCT01009645
- Acronym / sponsor ID
- Fact versus Myth Messages
- Conditions
- Influenza Vaccination
- Keywords
- education, vaccination, preventive service, Prevention & Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Nov 2009 (estimated)
- Results
- Posted 18 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fact Only | Experimental | Behavioral: Fact Only Education MessageThe educational message used will contain facts only. |
| Fact and Myth | Experimental | Behavioral: Fact and Myth Educational MessageThe educational material seen by this arm will contain facts and myths only. |
| Fact, Myth, Why | Experimental | Behavioral: Fact, Myth, Why Educational MessageThe educational material seen by this arm will contain myths, facts, and refutations of the myths. |
| Control | Placebo comparator | Behavioral: Control Educational MessageThis arm will receive fact/myth educational materials originally developed and used by the CDC. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must have a scheduled appointment at least 6 weeks in advance in either the GIM or Geriatrics clinics at NMFF.
- Participant must be a patient of Northwestern Medical Faculty Foundation.
- Participant does not intend to receive the influenza vaccine.
Key exclusion criteria (3 listed)
- Participant has a diagnosis of Alzheimer's Disease or Dementia
- Participant has received an influenza vaccination during either the last influenza season or the current.
- The scheduled visit is the participant's first time being seen by this doctor (appointment is to establish care in the clinic).
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 |
|---|---|---|
| Fact Only Education MessageAlso: Fact OnlyParticipants randomized to this intervention will receive an educational brochure listing the facts of the influenza vaccine. | Behavioural | Fact Only |
| Fact and Myth Educational MessageAlso: Fact & MythParticipants randomized to this intervention will receive an educational brochure listing the facts and myths of the influenza vaccine. | Behavioural | Fact and Myth |
| Fact, Myth, Why Educational MessageAlso: Fact, Myth, WhyParticipants randomized to this intervention will receive an educational brochure listing the facts, myths, and refutation of the myths of the influenza vaccine. | Behavioural | Fact, Myth, Why |
| Control Educational MessageAlso: ControlParticipants randomized to this intervention will receive an educational brochure created and used by the CDC in a previous influenza season. | Behavioural | Control |
Primary outcome
Influenza Vaccination
Time frame: 1 week following randomization
The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit.
1 secondary outcome
Recall Accuracy
Time frame: 1 week following receipt of message
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fact Only Education Message, Fact and Myth Educational Message and Fact, Myth, Why Educational Message in people with Influenza Vaccination, run by Northwestern 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 3 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 Oct 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Influenza Vaccination (time frame: 1 week following randomization). 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 30 Oct 2023.