An interventional study of Fact Only Education Message and Fact and Myth Educational Message in Influenza Vaccination, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 125 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The educational message used will contain facts only.
Behavioral: Fact Only Education Message
The educational material seen by this arm will contain facts and myths only.
Behavioral: Fact and Myth Educational Message
The educational material seen by this arm will contain myths, facts, and refutations of the myths.
Behavioral: Fact, Myth, Why Educational Message
This arm will receive fact/myth educational materials originally developed and used by the CDC.
Behavioral: Control Educational Message
Participants randomized to this intervention will receive an educational brochure listing the facts of the influenza vaccine.
Also known as: Fact Only
Participants randomized to this intervention will receive an educational brochure listing the facts and myths of the influenza vaccine.
Also known as: Fact & Myth
Participants randomized to this intervention will receive an educational brochure listing the facts, myths, and refutation of the myths of the influenza vaccine.
Also known as: Fact, Myth, Why
Participants randomized to this intervention will receive an educational brochure created and used by the CDC in a previous influenza season.
Also known as: Control
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.
Time frame: 1 week following randomization
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.
Time frame: 1 week following receipt of message
Eligible participants had scheduled appointments in a private medical clinic during October 2009 - March 2010. Potential participants were sent an opt-out letter indicating that they would be receiving a phone call to invite them to participate in a study if interested; those not opting out were contacted and asked to participate.
| Milestone | Fact Only | Fact and Myth | Fact, Myth, Why | Control |
|---|---|---|---|---|
| Started | 31 | 31 | 32 | 31 |
| Completed | 29 | 23 | 28 | 26 |
| Not completed | 2 | 8 | 4 | 5 |
| Withdrew: Lost to follow-up | 2 | 8 | 4 | 5 |
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.
| participants | Fact Only | Fact and Myth | Fact, Myth, Why | Control |
|---|---|---|---|---|
| Influenza Vaccination | 4 | 1 | 3 | 4 |
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.
| units on a scale | Fact Only | Fact and Myth | Fact, Myth, Why | Control |
|---|---|---|---|---|
| Recall Accuracy | 3.13 ± 1.66 | 4.52 ± 1.96 | 5.67 ± 1.65 | 4.77 ± 1.82 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fact Only | — | 0/31 (0%) | 0/31 (0%) |
| Fact and Myth | — | 0/31 (0%) | 0/31 (0%) |
| Fact, Myth, Why | — | 0/32 (0%) | 0/32 (0%) |
| Control | — | 0/31 (0%) | 0/31 (0%) |
| Age, Categorical(Participants) | Fact Only | Fact and Myth | Fact, Myth, Why | Control | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 20 | 23 | 16 | 77 |
| >=65 years | 13 | 11 | 9 | 15 | 48 |
| Age, Continuous(years) | Fact Only | Fact and Myth | Fact, Myth, Why | Control | Total |
|---|---|---|---|---|---|
| Mean | 62.8 ± 11.27 | 61.13 ± 7.46 | 63.34 ± 9.64 | 65.35 ± 8.40 | 63.16 ± 9.43 |
| Sex: Female, Male(Participants) | Fact Only | Fact and Myth | Fact, Myth, Why | Control | Total |
|---|---|---|---|---|---|
| Female | 27 | 24 | 23 | 24 | 98 |
| Male | 4 | 7 | 9 | 7 | 27 |
| Region of Enrollment(participants) | Fact Only | Fact and Myth | Fact, Myth, Why | Control | Total |
|---|---|---|---|---|---|
| United States | 31 | 31 | 32 | 31 | 125 |
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Northwestern University