Increasing Influenza Vaccination in Individuals With Cardiovascular Conditions: Assessing the Effectiveness of a Digital Intervention in a Decentralized Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 49,138
- Locations
- 1
- Primary Endpoint
- Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
cardiovascular disorders without digital intervention arm
Individuals with cardiovascular disease who receive no intervention
cardiovascular disorders digital intervention arm (CVD-I)
Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination
Intervention: Targeted digital intervention (Other)
Outcomes
Primary Outcomes
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
Time Frame: 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 Outcomes
- Participant Completion Rate(Up to 7 months)
- Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated(Up to 7 months)
- Self-Reported Influenza Vaccination Status Prediction(Up to 7 months)