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OpenTrials
Completed

NCT Number: NCT04584645

A Digital Flu Intervention for People With Cardiovascular Conditions

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

Completed

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Key information

Conditions

Cardiovascular Diseases Abnormal Heart Rhythms Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiac Arrest Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Coronary Disease Coronary Heart Disease Heart Arrest Heart Attack Heart Diseases Heart Failure Infarction Infections Influenza, Human Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stroke Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evidation Health

San Mateo, California, 94401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted digital intervention

Other

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.

Primary outcomes

  1. 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

  1. Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Evidation Health

Industry

Collaborators

  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study title

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

Acronym: CardioFlu

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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