A Digital Flu Intervention for People With Cardiovascular Conditions

Stroke Clinical Trial

— CardioFlu  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584645
• Other study ID #: 2020/08/14
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: April 12, 2021

Study information

• Verified date: May 2022
• Source: Evidation Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49138
• Est. completion date: April 12, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Heart Rhythms
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrest
• Cardiovascular Diseases
• Cerebrovascular Accident
• Coronary Disease
• Coronary Heart Disease
• Heart Attack
• Heart Diseases
• Heart Failure
• Myocardial Infarction
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Evidation Health	San Mateo	California

Sponsors (2)

Lead Sponsor	Collaborator
Evidation Health	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (14)

Dale LP, White L, Mitchell M, Faulkner G. Smartphone app uses loyalty point incentives and push notifications to encourage influenza vaccine uptake. Vaccine. 2019 Jul 26;37(32):4594-4600. doi: 10.1016/j.vaccine.2018.04.018. Epub 2018 Apr 23. — View Citation

Dos Santos G, Tahrat H, Bekkat-Berkani R. Immunogenicity, safety, and effectiveness of seasonal influenza vaccination in patients with diabetes mellitus: A systematic review. Hum Vaccin Immunother. 2018;14(8):1853-1866. doi: 10.1080/21645515.2018.1446719. Epub 2018 Apr 9. — View Citation

Doyle JD, Chung JR, Kim SS, Gaglani M, Raiyani C, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Monto AS, Martin ET, Belongia EA, McLean HQ, Foust A, Sessions W, Berman L, Garten RJ, Barnes JR, Wentworth DE, Fry AM, Patel MM, Flannery B. Interim Estimates of 2018-19 Seasonal Influenza Vaccine Effectiveness - United States, February 2019. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):135-139. doi: 10.15585/mmwr.mm6806a2. — View Citation

Frank L, Basch E, Selby JV; Patient-Centered Outcomes Research Institute. The PCORI perspective on patient-centered outcomes research. JAMA. 2014 Oct 15;312(15):1513-4. doi: 10.1001/jama.2014.11100. — View Citation

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/

Hurley LP, Beaty B, Lockhart S, Gurfinkel D, Breslin K, Dickinson M, Whittington MD, Roth H, Kempe A. RCT of Centralized Vaccine Reminder/Recall for Adults. Am J Prev Med. 2018 Aug;55(2):231-239. doi: 10.1016/j.amepre.2018.04.022. Epub 2018 Jun 15. — View Citation

Jackson ML, Chung JR, Jackson LA, Phillips CH, Benoit J, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman R, Nowalk MP, Fry AM, Flannery B. Influenza Vaccine Effectiveness in the United States during the 2015-2016 Season. N Engl J Med. 2017 Aug 10;377(6):534-543. doi: 10.1056/NEJMoa1700153. — View Citation

Lee WN, Stück D, Konty K, Rivers C, Brown CR, Zbikowski SM, Foschini L. Large-scale influenza vaccination promotion on a mobile app platform: A randomized controlled trial. Vaccine. 2020 Apr 16;38(18):3508-3514. doi: 10.1016/j.vaccine.2019.11.053. Epub 2019 Nov 29. — View Citation

Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. Epub 2007 Apr 20. — View Citation

Nehme EK, Delphia M, Cha EM, Thomas M, Lakey D. Promoting Influenza Vaccination Among an ACA Health Plan Subscriber Population: A Randomized Trial. Am J Health Promot. 2019 Jul;33(6):916-920. doi: 10.1177/0890117118823157. Epub 2019 Jan 10. — View Citation

Rolfes MA, Flannery B, Chung JR, O'Halloran A, Garg S, Belongia EA, Gaglani M, Zimmerman RK, Jackson ML, Monto AS, Alden NB, Anderson E, Bennett NM, Billing L, Eckel S, Kirley PD, Lynfield R, Monroe ML, Spencer M, Spina N, Talbot HK, Thomas A, Torres SM, Yousey-Hindes K, Singleton JA, Patel M, Reed C, Fry AM; US Influenza Vaccine Effectiveness (Flu VE) Network, the Influenza Hospitalization Surveillance Network, and the Assessment Branch, Immunization Services Division, Centers for Disease Control and Prevention. Effects of Influenza Vaccination in the United States During the 2017-2018 Influenza Season. Clin Infect Dis. 2019 Nov 13;69(11):1845-1853. doi: 10.1093/cid/ciz075. — View Citation

Samson SI, Konty K, Lee WN, Quisel T, Foschini L, Kerr D, Liska J, Mills H, Hollingsworth R, Greenberg M, Beal AC. Quantifying the Impact of Influenza Among Persons With Type 2 Diabetes Mellitus: A New Approach to Determine Medical and Physical Activity Impact. J Diabetes Sci Technol. 2021 Jan;15(1):44-52. doi: 10.1177/1932296819883340. Epub 2019 Nov 20. — View Citation

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.

Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 7 months
Secondary	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	Up to 7 months
Secondary	Participant Completion Rate	Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention	Up to 7 months
Secondary	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.	Up to 7 months

External Links

•   CDC Flu & Heart Disease and Stroke
•   CDC FluVaxView Interactive, National Center for Immunization and Respiratory Diseases (NCIRD)
•   CDC Seasonal Influenza Vaccine Effectiveness