Clinical trial NCT04584645: A Digital Flu Intervention 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Atrial Fibrillation
Abnormal Heart Rhythms
Cardiac Arrest
Heart Attack
Myocardial Infarction
Coronary Heart Disease
Heart Failure
Stroke
Cerebrovascular Accident
Keywords: Cardiovascular disease
Flu
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2020-10-14
Enrollment: 49138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
timeFrame: Up to 7 months
Secondary outcomes:
measure: Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
timeFrame: Up to 7 months
measure: Participant Completion Rate
timeFrame: Up to 7 months
measure: Self-Reported Influenza Vaccination Status Prediction
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
affiliation: Evidation Health
name: Nell Marshall, DrPh
role: PRINCIPAL_INVESTIGATOR
References:
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