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CardioFlu: A Digital Flu Intervention for People With Cardiovascular Conditions

Sponsor
Evidation Health (Industry)
Overall Status
Completed
CT.gov ID
NCT04584645
Collaborator
Sanofi Pasteur, a Sanofi Company (Industry)
49,138
Enrollment
1
Location
2
Arms
6.7
Actual Duration (Months)
7367.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Targeted digital intervention
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
49138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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.
Primary Purpose:
Prevention
Official Title:
Increasing Influenza Vaccination in Individuals With Cardiovascular Conditions: Assessing the Effectiveness of a Digital Intervention in a Decentralized Randomized Controlled Trial
Actual Study Start Date :
Sep 21, 2020
Actual Primary Completion Date :
Apr 12, 2021
Actual Study Completion Date :
Apr 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: cardiovascular disorders digital intervention arm (CVD-I)

Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination

Other: 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.
No Intervention: cardiovascular disorders without digital intervention arm

Individuals with cardiovascular disease who receive no intervention

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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

  2. Participant Completion Rate [Up to 7 months]

    Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Evidation Health San Mateo California United States 94401

Sponsors and Collaborators

  • Evidation Health
  • Sanofi Pasteur, a Sanofi Company

Investigators

  • Principal Investigator: Nell Marshall, DrPh, Evidation Health

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Evidation Health
ClinicalTrials.gov Identifier:
NCT04584645
Other Study ID Numbers:
  • 2020/08/14
First Posted:
Oct 14, 2020
Last Update Posted:
Jun 21, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Evidation Health
Cardiovascular disease
Flu
Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Coronary Disease
Arrhythmias, Cardiac

Study Results

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.
Pre-assignment Detail
Arm/Group Title Cardiovascular Disorders Digital Intervention Arm (CVD-I) Cardiovascular Disorders Without Digital Intervention Arm
Arm/Group Description 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. Individuals with cardiovascular disease who receive no intervention
Period Title: Overall Study
STARTED 24570 24568
COMPLETED 5575 5662
NOT COMPLETED 18995 18906

Baseline Characteristics

Arm/Group Title Cardiovascular Disorders Digital Intervention Arm (CVD-I) Cardiovascular Disorders Without Digital Intervention Arm Total
Arm/Group Description 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. Individuals with cardiovascular disease who receive no intervention Total of all reporting groups
Overall Participants 5575 5662 11237
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
45.0
(13.3)
44.9
(13.5)
44.95
(13.4)
Sex/Gender, Customized (Count of Participants)
Woman
4339
77.8%
4427
78.2%
8766
78%
Man
1071
19.2%
1114
19.7%
2185
19.4%
Other
169
3%
135
2.4%
304
2.7%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan Native
155
2.8%
143
2.5%
298
2.7%
Asian
250
4.5%
227
4%
477
4.2%
Black or African American
388
7%
354
6.3%
742
6.6%
Hispanic, Latino, or Spanish
319
5.7%
375
6.6%
694
6.2%
Middle Eastern or North African
46
0.8%
50
0.9%
96
0.9%
Native Hawaiian or Other Pacific Islander
45
0.8%
49
0.9%
94
0.8%
White
4510
80.9%
4612
81.5%
9122
81.2%
Another race or ethnicity not listed here
60
1.1%
64
1.1%
124
1.1%
I prefer not to answer
187
3.4%
179
3.2%
366
3.3%
Has Health Insurance (Count of Participants)
Yes
4815
86.4%
4872
86%
9687
86.2%
No
343
6.2%
368
6.5%
711
6.3%
I don't know / I'm not sure
50
0.9%
53
0.9%
103
0.9%
I prefer not to answer
42
0.8%
57
1%
99
0.9%
No response
325
5.8%
312
5.5%
637
5.7%
Has a College Degree (Count of Participants)
Count of Participants [Participants]
3510
63%
3381
59.7%
6891
61.3%
Household Income ≥ 75,000 (Count of Participants)
Count of Participants [Participants]
1909
34.2%
1861
32.9%
3770
33.5%
Heart Conditions (participants) [Number]
Arrhythmia
2251
40.4%
2331
41.2%
4582
40.8%
Atrial fibrillation
488
8.8%
496
8.8%
984
8.8%
Cardiac arrest
112
2%
99
1.7%
211
1.9%
Heart attack
385
6.9%
412
7.3%
797
7.1%
Heart failure
332
6%
293
5.2%
625
5.6%
Coronary heart disease
366
6.6%
356
6.3%
722
6.4%
Stroke or CVA
433
7.8%
436
7.7%
869
7.7%
Other cardiovascular diseases
539
9.7%
545
9.6%
1084
9.6%
None of the above diagnoses
1798
32.3%
1844
32.6%
3642
32.4%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Cardiovascular Disorders Digital Intervention Arm (CVD-I) Cardiovascular Disorders Without Digital Intervention Arm
Arm/Group Description 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. Individuals with cardiovascular disease who receive no intervention
Measure Participants 5575 5662
Count of Participants [Participants]
3418
61.3%
3355
59.3%
2. Secondary Outcome
Title Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
Description 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

Outcome Measure Data

Analysis Population Description
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/Group Title Participants Who Reported Influenza Vaccine After Completing 0 Interventions Participants Who Reported Influenza Vaccine After Completing 1 Intervention Participants Who Reported Influenza Vaccine After Completing 2 Interventions Participants Who Reported Influenza Vaccine After Completing 3 Interventions Participants Who Reported Influenza Vaccine After Completing 4 Interventions Participants Who Reported Influenza Vaccine After Completing 5 Interventions Participants Who Reported Influenza Vaccine After Completing 6 Interventions
Arm/Group Description Participants who Self-reported Influenza Vaccination After Study Start after interacting With 0 Intervention Messages Through Study Close Participants who Self-reported Influenza Vaccination After Study Start after interacting With 1 Intervention Message Through Study Close Participants who Self-reported Influenza Vaccination After Study Start after interacting With 2 Intervention Messages Through Study Close Participants who Self-reported Influenza Vaccination After Study Start after interacting With 3 Intervention Messages Through Study Close Participants who Self-reported Influenza Vaccination After Study Start after interacting With 4 Intervention Messages Through Study Close Participants who Self-reported Influenza Vaccination After Study Start after interacting With 5 Intervention Messages Through Study Close Participants who Self-reported Influenza Vaccination After Study Start after interacting With 6 Intervention Messages Through Study Close
Measure Participants 424 354 392 455 592 837 2476
Count of Participants [Participants]
211
3.8%
184
3.2%
245
2.2%
276
NaN
355
NaN
510
NaN
1612
NaN
3. Secondary Outcome
Title Participant Completion Rate
Description Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention
Time Frame Up to 7 months

Outcome Measure Data

Analysis Population Description
Participants in the intervention arm who received and responded to either the 3 or 6 month survey.
Arm/Group Title Completion Rate of Educational Videos Completion Rate of Knowledge Quiz Completion Rate of Cost Article Completion Rate of CDC Heart-Focused Article Completion Rate of Location Finder Completion Rate of Date Setter
Arm/Group Description Percentage of Participants that Completed the Intervention "Educational Videos" Percentage of Participants that Completed the Intervention "Knowledge Quiz" Percentage of Participants that Completed the Intervention "Cost Article" Percentage of Participants that Completed the Intervention "CDC Heart-Focused Article" Percentage of Participants that Completed the Intervention "Location Finder" Percentage of Participants that Completed the Intervention "Date Setter"
Measure Participants 5531 5531 5531 5531 5531 5531
Count of Participants [Participants]
3789
68%
4216
74.5%
4243
37.8%
4283
NaN
3740
NaN
3682
NaN
4. Secondary Outcome
Title Self-Reported Influenza Vaccination Status Prediction
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Influenza Vaccine Offered High Risk Group Informed Sees Primary Care Physician Hospitalized Sees Cardiologist
Arm/Group Description The health behavior "Influenza Vaccine Offered" as a predictor of influenza vaccination The health behavior "High Risk Group Informed" as a predictor of influenza vaccination The health behavior "Sees Primary Care Physician" as a predictor of influenza vaccination The health behavior "Hospitalized" as a predictor of influenza vaccination The health behavior "Sees Cardiologist" as a predictor of influenza vaccination
Measure Participants 11237 11237 11237 11237 11237
Mean (95% Confidence Interval) [Odds ratio of influenza vaccination]
11.2
2.37
1.9
1.89
1.63

Adverse Events

Time Frame Up to 7 months
Adverse Event Reporting Description Adverse Events were not collected or assessed as part of this study.
Arm/Group Title Cardiovascular Disorders Digital Intervention Arm (CVD-I) Cardiovascular Disorders Without Digital Intervention Arm
Arm/Group Description 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. Individuals with cardiovascular disease who receive no intervention
All Cause Mortality
Cardiovascular Disorders Digital Intervention Arm (CVD-I) Cardiovascular Disorders Without Digital Intervention Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Serious Adverse Events
Cardiovascular Disorders Digital Intervention Arm (CVD-I) Cardiovascular Disorders Without Digital Intervention Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Cardiovascular Disorders Digital Intervention Arm (CVD-I) Cardiovascular Disorders Without Digital Intervention Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Director, Enterprise Research Design
Organization Evidation Health
Phone 650-389-9550
Email results@evidation.com
Responsible Party:
Evidation Health
ClinicalTrials.gov Identifier:
NCT04584645
Other Study ID Numbers:
  • 2020/08/14
First Posted:
Oct 14, 2020
Last Update Posted:
Jun 21, 2022
Last Verified:
May 1, 2022