Trial Outcomes & Findings for The Effect of Fact Versus Myth Messages on Receipt of Influenza Vaccination (NCT NCT01009645)
NCT ID: NCT01009645
Last Updated: 2023-10-30
Results Overview
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.
COMPLETED
NA
125 participants
1 week following randomization
2023-10-30
Participant Flow
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.
If potential participants had already received the seasonal influenza vaccination for 2009 - 2010 or responded on the phone that they "definitely intended" to receive the vaccine, they were excluded from the study. These screening questions were asked prior to enrollment into the study.
Participant milestones
| Measure |
Fact Only
The educational message used will contain facts only.
|
Fact and Myth
The educational material seen by this arm will contain facts and myths only.
|
Fact, Myth, Why
The educational material seen by this arm will contain myths, facts, and refutations of the myths.
|
Control
This arm will receive fact/myth educational materials originally developed and used by the CDC.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
32
|
31
|
|
Overall Study
COMPLETED
|
29
|
23
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
4
|
5
|
Reasons for withdrawal
| Measure |
Fact Only
The educational message used will contain facts only.
|
Fact and Myth
The educational material seen by this arm will contain facts and myths only.
|
Fact, Myth, Why
The educational material seen by this arm will contain myths, facts, and refutations of the myths.
|
Control
This arm will receive fact/myth educational materials originally developed and used by the CDC.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
8
|
4
|
5
|
Baseline Characteristics
The Effect of Fact Versus Myth Messages on Receipt of Influenza Vaccination
Baseline characteristics by cohort
| Measure |
Fact Only
n=31 Participants
The educational message used will contain facts only.
|
Fact and Myth
n=31 Participants
The educational material seen by this arm will contain facts and myths only.
|
Fact, Myth, Why
n=32 Participants
The educational material seen by this arm will contain myths, facts, and refutations of the myths.
|
Control
n=31 Participants
This arm will receive fact/myth educational materials originally developed and used by the CDC.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 11.27 • n=99 Participants
|
61.13 years
STANDARD_DEVIATION 7.46 • n=107 Participants
|
63.34 years
STANDARD_DEVIATION 9.64 • n=206 Participants
|
65.35 years
STANDARD_DEVIATION 8.40 • n=7 Participants
|
63.16 years
STANDARD_DEVIATION 9.43 • n=31 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
98 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=99 Participants
|
31 participants
n=107 Participants
|
32 participants
n=206 Participants
|
31 participants
n=7 Participants
|
125 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 week following randomizationThe 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.
Outcome measures
| Measure |
Fact Only
n=31 Participants
The educational message used will contain facts only.
|
Fact and Myth
n=31 Participants
The educational material seen by this arm will contain facts and myths only.
|
Fact, Myth, Why
n=32 Participants
The educational material seen by this arm will contain myths, facts, and refutations of the myths.
|
Control
n=31 Participants
This arm will receive fact/myth educational materials originally developed and used by the CDC.
|
|---|---|---|---|---|
|
Influenza Vaccination
|
4 participants
|
1 participants
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 1 week following receipt of messageParticipants 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.
Outcome measures
| Measure |
Fact Only
n=31 Participants
The educational message used will contain facts only.
|
Fact and Myth
n=31 Participants
The educational material seen by this arm will contain facts and myths only.
|
Fact, Myth, Why
n=32 Participants
The educational material seen by this arm will contain myths, facts, and refutations of the myths.
|
Control
n=31 Participants
This arm will receive fact/myth educational materials originally developed and used by the CDC.
|
|---|---|---|---|---|
|
Recall Accuracy
|
3.13 units on a scale
Standard Deviation 1.66
|
4.52 units on a scale
Standard Deviation 1.96
|
5.67 units on a scale
Standard Deviation 1.65
|
4.77 units on a scale
Standard Deviation 1.82
|
Adverse Events
Fact Only
Fact and Myth
Fact, Myth, Why
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place