A Digital Flu Intervention for People With Cardiovascular Conditions

Not Applicable

Completed

• Conditions: Coronary Heart Disease; Cerebrovascular Accident; Cardiovascular Diseases; Atrial Fibrillation; Myocardial Infarction; Heart Failure; Cardiac Arrest; Heart Attack; Stroke; Abnormal Heart Rhythms
• Interventions: Other: Targeted digital intervention

• Registration Number: NCT04584645
• Lead Sponsor: Evidation Health

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-15
• Study Start: 2020-09-21
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-14
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-12
• Results First Submitted: 2022-02-07
• Results First Submitted QC: 2022-02-22
• Status Verified: 2022-05
• Results First Posted: 2022-05-10
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cardiovascular disorders digital intervention arm (CVD-I)	Targeted digital intervention	Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination

Primary Outcome Measures

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

Name	Time	Method
Participant Completion Rate	Up to 7 months	Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention
Self-Reported Influenza Vaccination Status Prediction	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.
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated	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

Trial Locations

Locations (1)

Evidation Health; 🇺🇸 San Mateo, California, United States