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

Primary Purpose

Cardiovascular Diseases, Atrial Fibrillation, Abnormal Heart Rhythms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Targeted digital intervention

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Cardiovascular disease, Flu

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Evidation Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cardiovascular disorders digital intervention arm (CVD-I)

cardiovascular disorders without digital intervention arm

Arm Description

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

Individuals with cardiovascular disease who receive no intervention

Outcomes

Primary Outcome Measures

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

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

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

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

Participant Completion Rate

Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention

Self-Reported Influenza Vaccination Status Prediction

Development of a logistic regression model to predict self-reported influenza vaccination status using vaccination predictors such as vaccine drivers/barriers, and vaccine knowledge.

Full Information

NCT ID

NCT04584645

First Posted

September 15, 2020

Last Updated

May 23, 2022

Sponsor

Evidation Health

Collaborators

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT04584645

Brief Title

A Digital Flu Intervention for People With Cardiovascular Conditions

Acronym

CardioFlu

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

September 21, 2020 (Actual)

Primary Completion Date

April 12, 2021 (Actual)

Study Completion Date

April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Evidation Health

Collaborators

Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

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.

Allocation

Randomized

Enrollment

49138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cardiovascular disorders digital intervention arm (CVD-I)

Arm Type

Experimental

Arm Description

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

Arm Title

cardiovascular disorders without digital intervention arm

Arm Type

No Intervention

Arm Description

Individuals with cardiovascular disease who receive no intervention

Intervention Type

Other

Intervention Name(s)

Targeted digital intervention

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

Up to 7 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 7 months

Title

Participant Completion Rate

Description

Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention

Time Frame

Up to 7 months

Title

Self-Reported Influenza Vaccination Status Prediction

Description

Development of a logistic regression model to predict self-reported influenza vaccination status using vaccination predictors such as vaccine drivers/barriers, and vaccine knowledge.

Time Frame

Up to 7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nell Marshall, DrPh

Organizational Affiliation

Evidation Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Evidation Health

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29699784

Citation

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Citation

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Results Reference

derived

Links:

URL

https://www.cdc.gov/flu/highrisk/heartdisease.htm

Description

CDC Flu & Heart Disease and Stroke

Learn more about this trial

A Digital Flu Intervention for People With Cardiovascular Conditions

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