A Digital Flu Intervention for People With Cardiovascular Conditions

Study Overview
=================
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

Official Title
-----------------
Increasing Influenza Vaccination in Individuals With Cardiovascular Conditions: Assessing the Effectiveness of a Digital Intervention in a Decentralized Randomized Controlled Trial

Conditions
-----------------
Cardiovascular Diseases, Atrial Fibrillation, Abnormal Heart Rhythms, Cardiac Arrest, Heart Attack, Myocardial Infarction, Coronary Heart Disease, Heart Failure, Stroke, Cerebrovascular Accident

Intervention / Treatment
-----------------
* Other: Targeted digital intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cardiovascular disorders digital intervention arm (CVD-I)<br>Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination | Other: Targeted digital intervention<br>* 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.<br>|
| No Intervention: cardiovascular disorders without digital intervention arm<br>Individuals with cardiovascular disease who receive no intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 7 months | 
| Participant Completion Rate | Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention | Up to 7 months | 
| 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. | Up to 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular disease, Flu