Trial Outcomes & Findings for A Digital Flu Intervention for People With Cardiovascular Conditions (NCT NCT04584645)
NCT ID: NCT04584645
Last Updated: 2022-06-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49138 participants
Primary outcome timeframe
Up to 7 months
Results posted on
2022-06-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Cardiovascular Disorders Without Digital Intervention Arm
Individuals with cardiovascular disease who receive no intervention
|
|---|---|---|
|
Overall Study
STARTED
|
24570
|
24568
|
|
Overall Study
COMPLETED
|
5575
|
5662
|
|
Overall Study
NOT COMPLETED
|
18995
|
18906
|
Reasons for withdrawal
| Measure |
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.
|
Cardiovascular Disorders Without Digital Intervention Arm
Individuals with cardiovascular disease who receive no intervention
|
|---|---|---|
|
Overall Study
Those participants who did not complete the 3 or 6 month surveys are considered "not completed".
|
18995
|
18906
|
Baseline Characteristics
A Digital Flu Intervention for People With Cardiovascular Conditions
Baseline characteristics by cohort
| Measure |
Cardiovascular Disorders Digital Intervention Arm (CVD-I)
n=5575 Participants
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.
|
Cardiovascular Disorders Without Digital Intervention Arm
n=5662 Participants
Individuals with cardiovascular disease who receive no intervention
|
Total
n=11237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
44.95 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex/Gender, Customized
Woman
|
4339 Participants
n=5 Participants
|
4427 Participants
n=7 Participants
|
8766 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Man
|
1071 Participants
n=5 Participants
|
1114 Participants
n=7 Participants
|
2185 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
169 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
155 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
250 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
388 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
742 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latino, or Spanish
|
319 Participants
n=5 Participants
|
375 Participants
n=7 Participants
|
694 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern or North African
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4510 Participants
n=5 Participants
|
4612 Participants
n=7 Participants
|
9122 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Another race or ethnicity not listed here
|
60 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
I prefer not to answer
|
187 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
|
Has Health Insurance
Yes
|
4815 Participants
n=5 Participants
|
4872 Participants
n=7 Participants
|
9687 Participants
n=5 Participants
|
|
Has Health Insurance
No
|
343 Participants
n=5 Participants
|
368 Participants
n=7 Participants
|
711 Participants
n=5 Participants
|
|
Has Health Insurance
I don't know / I'm not sure
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Has Health Insurance
I prefer not to answer
|
42 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Has Health Insurance
No response
|
325 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
637 Participants
n=5 Participants
|
|
Has a College Degree
|
3510 Participants
n=5 Participants
|
3381 Participants
n=7 Participants
|
6891 Participants
n=5 Participants
|
|
Household Income ≥ 75,000
|
1909 Participants
n=5 Participants
|
1861 Participants
n=7 Participants
|
3770 Participants
n=5 Participants
|
|
Heart Conditions
Arrhythmia
|
2251 participants
n=5 Participants
|
2331 participants
n=7 Participants
|
4582 participants
n=5 Participants
|
|
Heart Conditions
Atrial fibrillation
|
488 participants
n=5 Participants
|
496 participants
n=7 Participants
|
984 participants
n=5 Participants
|
|
Heart Conditions
Cardiac arrest
|
112 participants
n=5 Participants
|
99 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Heart Conditions
Heart attack
|
385 participants
n=5 Participants
|
412 participants
n=7 Participants
|
797 participants
n=5 Participants
|
|
Heart Conditions
Heart failure
|
332 participants
n=5 Participants
|
293 participants
n=7 Participants
|
625 participants
n=5 Participants
|
|
Heart Conditions
Coronary heart disease
|
366 participants
n=5 Participants
|
356 participants
n=7 Participants
|
722 participants
n=5 Participants
|
|
Heart Conditions
Stroke or CVA
|
433 participants
n=5 Participants
|
436 participants
n=7 Participants
|
869 participants
n=5 Participants
|
|
Heart Conditions
Other cardiovascular diseases
|
539 participants
n=5 Participants
|
545 participants
n=7 Participants
|
1084 participants
n=5 Participants
|
|
Heart Conditions
None of the above diagnoses
|
1798 participants
n=5 Participants
|
1844 participants
n=7 Participants
|
3642 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 monthsTo 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.
Outcome measures
| Measure |
Cardiovascular Disorders Digital Intervention Arm (CVD-I)
n=5575 Participants
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.
|
Cardiovascular Disorders Without Digital Intervention Arm
n=5662 Participants
Individuals with cardiovascular disease who receive no intervention
|
Participants Who Reported Influenza Vaccine After Completing 2 Interventions
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 2 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 3 Interventions
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 3 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 4 Interventions
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 4 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 5 Interventions
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 5 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 6 Interventions
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 6 Intervention Messages Through Study Close
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
|
3418 Participants
|
3355 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: This population consists of all individuals who are in the intervention arm and who have responded to the 3-month or 6-month survey.
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
Outcome measures
| Measure |
Cardiovascular Disorders Digital Intervention Arm (CVD-I)
n=424 Participants
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.
|
Cardiovascular Disorders Without Digital Intervention Arm
n=354 Participants
Individuals with cardiovascular disease who receive no intervention
|
Participants Who Reported Influenza Vaccine After Completing 2 Interventions
n=392 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 2 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 3 Interventions
n=455 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 3 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 4 Interventions
n=592 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 4 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 5 Interventions
n=837 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 5 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 6 Interventions
n=2476 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 6 Intervention Messages Through Study Close
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
|
211 Participants
|
184 Participants
|
245 Participants
|
276 Participants
|
355 Participants
|
510 Participants
|
1612 Participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: Participants in the intervention arm who received and responded to either the 3 or 6 month survey.
Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention
Outcome measures
| Measure |
Cardiovascular Disorders Digital Intervention Arm (CVD-I)
n=5531 Participants
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.
|
Cardiovascular Disorders Without Digital Intervention Arm
n=5531 Participants
Individuals with cardiovascular disease who receive no intervention
|
Participants Who Reported Influenza Vaccine After Completing 2 Interventions
n=5531 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 2 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 3 Interventions
n=5531 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 3 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 4 Interventions
n=5531 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 4 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 5 Interventions
n=5531 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 5 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 6 Interventions
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 6 Intervention Messages Through Study Close
|
|---|---|---|---|---|---|---|---|
|
Participant Completion Rate
|
3789 Participants
|
4216 Participants
|
4243 Participants
|
4283 Participants
|
3740 Participants
|
3682 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 7 monthsDevelopment of a logistic regression model to predict self-reported influenza vaccination status using vaccination predictors such as vaccine drivers/barriers, and vaccine knowledge.
Outcome measures
| Measure |
Cardiovascular Disorders Digital Intervention Arm (CVD-I)
n=11237 Participants
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.
|
Cardiovascular Disorders Without Digital Intervention Arm
n=11237 Participants
Individuals with cardiovascular disease who receive no intervention
|
Participants Who Reported Influenza Vaccine After Completing 2 Interventions
n=11237 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 2 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 3 Interventions
n=11237 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 3 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 4 Interventions
n=11237 Participants
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 4 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 5 Interventions
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 5 Intervention Messages Through Study Close
|
Participants Who Reported Influenza Vaccine After Completing 6 Interventions
Participants who Self-reported Influenza Vaccination After Study Start after interacting With 6 Intervention Messages Through Study Close
|
|---|---|---|---|---|---|---|---|
|
Self-Reported Influenza Vaccination Status Prediction
|
11.2 Odds ratio of influenza vaccination
Interval 10.14 to 12.36
|
2.37 Odds ratio of influenza vaccination
Interval 2.17 to 2.59
|
1.9 Odds ratio of influenza vaccination
Interval 1.76 to 2.06
|
1.89 Odds ratio of influenza vaccination
Interval 1.57 to 2.27
|
1.63 Odds ratio of influenza vaccination
Interval 1.48 to 1.81
|
—
|
—
|
Adverse Events
Cardiovascular Disorders Digital Intervention Arm (CVD-I)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cardiovascular Disorders Without Digital Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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