Abnormal Heart Rhythms, Atrial Fibrillation, Cardiac Arrest, Cardiovascular Diseases, Cerebrovascular Accident, Coronary Heart Disease, Heart Attack, Heart Failure, Myocardial Infarction, Stroke
Conditions
Keywords
Cardiovascular disease, Flu
Brief summary
A 6-month prospective, digital randomized controlled trial targeting approximately 49,000 individuals to evaluate the effectiveness of an influenza vaccination intervention during influenza season for people with cardiovascular conditions
Interventions
OTHERTargeted digital intervention
Messages that provide informational content on the influenza vaccine (sourced from the Centers for Disease Control and Prevention and the American Heart Association), specific information about influenza and cardiovascular disorders, and behavioral prompts (e.g., reminders) surrounding influenza vaccination behaviors.
Sponsors
Sanofi Pasteur, a Sanofi Company
Evidation Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
A set of existing Achievement members who have previously self-reported to meeting the inclusion criteria will be tagged for study inclusion, termed participants. Since participants will be blinded to their study participation status, participants will not be asked to take any action to enroll in the study. In order to identify a target list of participants, Evidation Health will leverage already permissioned information from Achievement members, including data on their cardiovascular diagnoses, age, sex/gender, race/ethnicity, and country of residence.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Resides in the U.S. * Speaks, reads, and understands English * Has self-reported being diagnosed with any of the following cardiac conditions below in their Achievement profile: * Atrial Fibrillation or Afib * Abnormal or irregular heart rhythm, other arrhythmic heart disease * Cardiac arrest, or heart attack (myocardial infarction) * Coronary heart disease like a heart blockage, treated with medications, a stent in the heart, or sometimes bypass surgery- * Heart failure, like congestive heart failure * Stroke or cerebrovascular accident (CVA)
Exclusion criteria
* Participated in Step 1, Part 2 semi-structured interviews used to obtain feedback on the intervention messages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | Up to 7 months | To determine the effectiveness of a digital intervention designed to increase influenza vaccination rates in individuals with cardiovascular diagnoses (CV diagnoses) by examining differences in self-reported influenza vaccination rates between individuals with cardiovascular disease who receive a targeted digital intervention (CVD-I) aimed at increasing influenza vaccination and those with CV diagnoses who received no intervention (CVD-C) by the end of the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | Up to 7 months | Differences in rates of self-reported influenza vaccination status after study start between individuals in the intervention group that completed different numbers of intervention messages (0 to 6 messages) over the course of the study |
| Participant Completion Rate | Up to 7 months | Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention |
| Self-Reported Influenza Vaccination Status Prediction | Up to 7 months | Development of a logistic regression model to predict self-reported influenza vaccination status using vaccination predictors such as vaccine drivers/barriers, and vaccine knowledge. |
Countries
United States
Participant flow
Recruitment details
A set of existing Achievement members who previously reported meeting the inclusion criteria were tagged for study inclusion. These participants were randomized using block randomization before being offered the opportunity to complete any study activities. Participants were sent offers via the Achievement platform to complete study activities. Participants could complete any number of survey activities. Completion of intervention activities was not required for enrollment for the CVD-I group.
Participants by arm
| Arm | Count |
|---|---|
| Cardiovascular Disorders Digital Intervention Arm (CVD-I) Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination
Targeted digital intervention: Messages that provide informational content on the influenza vaccine (sourced from the Centers for Disease Control and Prevention and the American Heart Association), specific information about influenza and cardiovascular disorders, and behavioral prompts (e.g., reminders) surrounding influenza vaccination behaviors. | 5,575 |
| Cardiovascular Disorders Without Digital Intervention Arm Individuals with cardiovascular disease who receive no intervention | 5,662 |
| Total | 11,237 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Those participants who did not complete the 3 or 6 month surveys are considered not completed. | 18,995 | 18,906 |
Baseline characteristics
| Characteristic | Total | Cardiovascular Disorders Digital Intervention Arm (CVD-I) | Cardiovascular Disorders Without Digital Intervention Arm |
|---|---|---|---|
| Age, Continuous | 44.95 years STANDARD_DEVIATION 13.4 | 45.0 years STANDARD_DEVIATION 13.3 | 44.9 years STANDARD_DEVIATION 13.5 |
| Has a College Degree | 6891 Participants | 3510 Participants | 3381 Participants |
| Has Health Insurance I don't know / I'm not sure | 103 Participants | 50 Participants | 53 Participants |
| Has Health Insurance I prefer not to answer | 99 Participants | 42 Participants | 57 Participants |
| Has Health Insurance No | 711 Participants | 343 Participants | 368 Participants |
| Has Health Insurance No response | 637 Participants | 325 Participants | 312 Participants |
| Has Health Insurance Yes | 9687 Participants | 4815 Participants | 4872 Participants |
| Heart Conditions Arrhythmia | 4582 participants | 2251 participants | 2331 participants |
| Heart Conditions Atrial fibrillation | 984 participants | 488 participants | 496 participants |
| Heart Conditions Cardiac arrest | 211 participants | 112 participants | 99 participants |
| Heart Conditions Coronary heart disease | 722 participants | 366 participants | 356 participants |
| Heart Conditions Heart attack | 797 participants | 385 participants | 412 participants |
| Heart Conditions Heart failure | 625 participants | 332 participants | 293 participants |
| Heart Conditions None of the above diagnoses | 3642 participants | 1798 participants | 1844 participants |
| Heart Conditions Other cardiovascular diseases | 1084 participants | 539 participants | 545 participants |
| Heart Conditions Stroke or CVA | 869 participants | 433 participants | 436 participants |
| Household Income ≥ 75,000 | 3770 Participants | 1909 Participants | 1861 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 298 Participants | 155 Participants | 143 Participants |
| Race/Ethnicity, Customized Another race or ethnicity not listed here | 124 Participants | 60 Participants | 64 Participants |
| Race/Ethnicity, Customized Asian | 477 Participants | 250 Participants | 227 Participants |
| Race/Ethnicity, Customized Black or African American | 742 Participants | 388 Participants | 354 Participants |
| Race/Ethnicity, Customized Hispanic, Latino, or Spanish | 694 Participants | 319 Participants | 375 Participants |
| Race/Ethnicity, Customized I prefer not to answer | 366 Participants | 187 Participants | 179 Participants |
| Race/Ethnicity, Customized Middle Eastern or North African | 96 Participants | 46 Participants | 50 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 94 Participants | 45 Participants | 49 Participants |
| Race/Ethnicity, Customized White | 9122 Participants | 4510 Participants | 4612 Participants |
| Sex/Gender, Customized Man | 2185 Participants | 1071 Participants | 1114 Participants |
| Sex/Gender, Customized Other | 304 Participants | 169 Participants | 135 Participants |
| Sex/Gender, Customized Woman | 8766 Participants | 4339 Participants | 4427 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
To determine the effectiveness of a digital intervention designed to increase influenza vaccination rates in individuals with cardiovascular diagnoses (CV diagnoses) by examining differences in self-reported influenza vaccination rates between individuals with cardiovascular disease who receive a targeted digital intervention (CVD-I) aimed at increasing influenza vaccination and those with CV diagnoses who received no intervention (CVD-C) by the end of the study period.
Time frame: Up to 7 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiovascular Disorders Digital Intervention Arm (CVD-I) | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 3418 Participants |
| Cardiovascular Disorders Without Digital Intervention Arm | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 3355 Participants |
Secondary
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
Differences in rates of self-reported influenza vaccination status after study start between individuals in the intervention group that completed different numbers of intervention messages (0 to 6 messages) over the course of the study
Time frame: Up to 7 months
Population: This population consists of all individuals who are in the intervention arm and who have responded to the 3-month or 6-month survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiovascular Disorders Digital Intervention Arm (CVD-I) | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 211 Participants |
| Cardiovascular Disorders Without Digital Intervention Arm | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 184 Participants |
| Participants Who Reported Influenza Vaccine After Completing 2 Interventions | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 245 Participants |
| Participants Who Reported Influenza Vaccine After Completing 3 Interventions | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 276 Participants |
| Participants Who Reported Influenza Vaccine After Completing 4 Interventions | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 355 Participants |
| Participants Who Reported Influenza Vaccine After Completing 5 Interventions | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 510 Participants |
| Participants Who Reported Influenza Vaccine After Completing 6 Interventions | Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated | 1612 Participants |
Secondary
Participant Completion Rate
Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention
Time frame: Up to 7 months
Population: Participants in the intervention arm who received and responded to either the 3 or 6 month survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiovascular Disorders Digital Intervention Arm (CVD-I) | Participant Completion Rate | 3789 Participants |
| Cardiovascular Disorders Without Digital Intervention Arm | Participant Completion Rate | 4216 Participants |
| Participants Who Reported Influenza Vaccine After Completing 2 Interventions | Participant Completion Rate | 4243 Participants |
| Participants Who Reported Influenza Vaccine After Completing 3 Interventions | Participant Completion Rate | 4283 Participants |
| Participants Who Reported Influenza Vaccine After Completing 4 Interventions | Participant Completion Rate | 3740 Participants |
| Participants Who Reported Influenza Vaccine After Completing 5 Interventions | Participant Completion Rate | 3682 Participants |
Secondary
Self-Reported Influenza Vaccination Status Prediction
Development of a logistic regression model to predict self-reported influenza vaccination status using vaccination predictors such as vaccine drivers/barriers, and vaccine knowledge.
Time frame: Up to 7 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cardiovascular Disorders Digital Intervention Arm (CVD-I) | Self-Reported Influenza Vaccination Status Prediction | 11.2 Odds ratio of influenza vaccination |
| Cardiovascular Disorders Without Digital Intervention Arm | Self-Reported Influenza Vaccination Status Prediction | 2.37 Odds ratio of influenza vaccination |
| Participants Who Reported Influenza Vaccine After Completing 2 Interventions | Self-Reported Influenza Vaccination Status Prediction | 1.9 Odds ratio of influenza vaccination |
| Participants Who Reported Influenza Vaccine After Completing 3 Interventions | Self-Reported Influenza Vaccination Status Prediction | 1.89 Odds ratio of influenza vaccination |
| Participants Who Reported Influenza Vaccine After Completing 4 Interventions | Self-Reported Influenza Vaccination Status Prediction | 1.63 Odds ratio of influenza vaccination |