A Digital Flu Intervention for People With Cardiovascular Conditions (CardioFlu)

Evidation Health

Status: Completed

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

Treatments: Other: Targeted digital intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT04584645

2020/08/14

Details and patient eligibility

About

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

Enrollment: 49,138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49,138 participants in 2 patient groups

cardiovascular disorders digital intervention arm (CVD-I)

Experimental group

Description:

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

Treatment:

Other: Targeted digital intervention

cardiovascular disorders without digital intervention arm

No Intervention group

Description:

Individuals with cardiovascular disease who receive no intervention