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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG031470-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fact Only | Experimental | The educational message used will contain facts only. |
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| Fact and Myth | Experimental | The educational material seen by this arm will contain facts and myths only. |
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| Fact, Myth, Why | Experimental | The educational material seen by this arm will contain myths, facts, and refutations of the myths. |
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| Control | Placebo Comparator | This arm will receive fact/myth educational materials originally developed and used by the CDC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fact Only Education Message | Behavioral | Participants randomized to this intervention will receive an educational brochure listing the facts of the influenza vaccine. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Faculty Foundation General Internal Medicine and Geriatric Clinics | Chicago | Illinois | 60611 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fact Only | The educational message used will contain facts only. |
| FG001 | Fact and Myth | The educational material seen by this arm will contain facts and myths only. |
| FG002 | Fact, Myth, Why | The educational material seen by this arm will contain myths, facts, and refutations of the myths. |
| FG003 | Control | This arm will receive fact/myth educational materials originally developed and used by the CDC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fact Only | The educational message used will contain facts only. |
| BG001 | Fact and Myth | The educational material seen by this arm will contain facts and myths only. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 1 week following randomization |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fact Only | The educational message used will contain facts only. |
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Low participation in the trial due to the emergence of H1N1; many individuals >50 years of age opted to receive seasonal flu vaccine as they were initially unable to receive the H1N1 vaccine. Hence, the available study population shrank markedly.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenzie Cameron, PhD, MPH | Northwestern University | 312-503-3910 | kcameron@northwestern.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C489489 | SUPT16H protein, human |
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| Fact and Myth Educational Message | Behavioral | Participants randomized to this intervention will receive an educational brochure listing the facts and myths of the influenza vaccine. |
|
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| Fact, Myth, Why Educational Message | Behavioral | Participants randomized to this intervention will receive an educational brochure listing the facts, myths, and refutation of the myths of the influenza vaccine. |
|
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| Control Educational Message | Behavioral | Participants randomized to this intervention will receive an educational brochure created and used by the CDC in a previous influenza season. |
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| 1 week following receipt of message |
| BG002 | Fact, Myth, Why | The educational material seen by this arm will contain myths, facts, and refutations of the myths. |
| BG003 | Control | This arm will receive fact/myth educational materials originally developed and used by the CDC. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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The educational material seen by this arm will contain facts and myths only.
| OG002 | Fact, Myth, Why | The educational material seen by this arm will contain myths, facts, and refutations of the myths. |
| OG003 | Control | This arm will receive fact/myth educational materials originally developed and used by the CDC. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week following receipt of message |
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|
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| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Fact and Myth | The educational material seen by this arm will contain facts and myths only. | 0 | 31 | 0 | 31 |
| EG002 | Fact, Myth, Why | The educational material seen by this arm will contain myths, facts, and refutations of the myths. | 0 | 32 | 0 | 32 |
| EG003 | Control | This arm will receive fact/myth educational materials originally developed and used by the CDC. | 0 | 31 | 0 | 31 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |