- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01009645
The Effect of Fact Versus Myth Messages on Receipt of Influenza Vaccination
October 25, 2023 updated by: Northwestern University
The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Medical Faculty Foundation General Internal Medicine and Geriatric Clinics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fact Only
The educational message used will contain facts only.
|
Participants randomized to this intervention will receive an educational brochure listing the facts of the influenza vaccine.
Other Names:
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Experimental: Fact and Myth
The educational material seen by this arm will contain facts and myths only.
|
Participants randomized to this intervention will receive an educational brochure listing the facts and myths of the influenza vaccine.
Other Names:
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Experimental: Fact, Myth, Why
The educational material seen by this arm will contain myths, facts, and refutations of the myths.
|
Participants randomized to this intervention will receive an educational brochure listing the facts, myths, and refutation of the myths of the influenza vaccine.
Other Names:
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Placebo Comparator: Control
This arm will receive fact/myth educational materials originally developed and used by the CDC.
|
Participants randomized to this intervention will receive an educational brochure created and used by the CDC in a previous influenza season.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 week following randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recall Accuracy
Time Frame: 1 week following receipt of message
|
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.
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1 week following receipt of message
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
November 6, 2009
First Submitted That Met QC Criteria
November 6, 2009
First Posted (Estimated)
November 9, 2009
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fact versus Myth Messages
- 1R21AG031470-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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