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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584645
Recruitment Status : Completed
First Posted : October 14, 2020
Results First Posted : May 10, 2022
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Evidation Health

Study Description
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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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Atrial Fibrillation Abnormal Heart Rhythms Cardiac Arrest Heart Attack Myocardial Infarction Coronary Heart Disease Heart Failure Stroke Cerebrovascular Accident Other: Targeted digital intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Prevention
Official Title: Increasing Influenza Vaccination in Individuals With Cardiovascular Conditions: Assessing the Effectiveness of a Digital Intervention in a Decentralized Randomized Controlled Trial
Actual Study Start Date : September 21, 2020
Actual Primary Completion Date : April 12, 2021
Actual Study Completion Date : April 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: cardiovascular disorders digital intervention arm (CVD-I)
Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination
 Other: Targeted digital intervention
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.
No Intervention: cardiovascular disorders without digital intervention arm
Individuals with cardiovascular disease who receive no intervention


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584645


Locations
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United States, California
Evidation Health
San Mateo, California, United States, 94401
Sponsors and Collaborators
Evidation Health
Sanofi Pasteur, a Sanofi Company
Investigators
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Principal Investigator: Nell Marshall, DrPh Evidation Health
  Study Documents (Full-Text)

Documents provided by Evidation Health:
Study Protocol  [PDF] August 11, 2020
Statistical Analysis Plan  [PDF] February 18, 2021

More Information
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Additional Information:

Publications:
Healthy People 2020. (2019). Retrieved from https://www.healthypeople.gov/. from Healthy People 2020, United States Department of Health and Human Services, Office of Disease Prevention and Health Promotion, https://www.healthypeople.gov/
Samson, S., Lee, J., Tai, C., & Foschini, L. (2020, September). Digital intervention is effective at increasing influenza vaccination in people living with diabetes. Poster presented at the European Association for the Science of Diabetes in Vienna, Austria - Conference to occur digitally 22-25 September, 2020 due to COVID-19.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Evidation Health
ClinicalTrials.gov Identifier: NCT04584645    
Other Study ID Numbers: 2020/08/14
First Posted: October 14, 2020    Key Record Dates
Results First Posted: May 10, 2022
Last Update Posted: June 21, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evidation Health:
Cardiovascular disease
Flu
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Coronary Disease
Arrhythmias, Cardiac
Pathologic Processes
Infarction
 Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases