NCT04584645

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49,138

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 10, 2022

Completed
Last Updated

June 21, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

September 15, 2020

Results QC Date

February 7, 2022

Last Update Submit

May 23, 2022

Conditions

Cardiovascular DiseasesAtrial FibrillationAbnormal Heart RhythmsCardiac ArrestHeart AttackMyocardial InfarctionCoronary Heart DiseaseHeart FailureStrokeCerebrovascular Accident

Keywords

Cardiovascular diseaseFlu

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    Up to 7 months

  • Participant Completion Rate

    Up to 7 months

  • Self-Reported Influenza Vaccination Status Prediction

    Up to 7 months

Study Arms (2)

cardiovascular disorders digital intervention arm (CVD-I)

EXPERIMENTAL

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

Other: Targeted digital intervention

cardiovascular disorders without digital intervention arm

NO INTERVENTION

Individuals with cardiovascular disease who receive no intervention

Interventions

Targeted digital interventionOTHER

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.

cardiovascular disorders digital intervention arm (CVD-I)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Participated in Step 1, Part 2 semi-structured interviews used to obtain feedback on the intervention messages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidation Health

San Mateo, California, 94401, United States

Location

Related Publications (15)

  • 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.

    PMID: 29699784BACKGROUND

  • 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.

    PMID: 29517396BACKGROUND

  • 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.

    PMID: 30763298BACKGROUND

  • 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. No abstract available.

    PMID: 25167382BACKGROUND

  • 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/

    BACKGROUND

  • 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.

    PMID: 29910118BACKGROUND

  • 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.

    PMID: 28792867BACKGROUND

  • Lee WN, Stuck 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.

    PMID: 31787410BACKGROUND

  • 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. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.

    PMID: 17544181BACKGROUND

  • 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.

    PMID: 30630342BACKGROUND

  • 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.

    PMID: 30715278BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 31747789BACKGROUND

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

    PMID: 22263004BACKGROUND

  • Marshall NJ, Lee JL, Schroeder J, Lee WN, See J, Madjid M, Munagala MR, Piette JD, Tan L, Vardeny O, Greenberg M, Liska J, Mercer M, Samson S. Influence of Digital Intervention Messaging on Influenza Vaccination Rates Among Adults With Cardiovascular Disease in the United States: Decentralized Randomized Controlled Trial. J Med Internet Res. 2022 Oct 7;24(10):e38710. doi: 10.2196/38710.

    PMID: 36206046DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesAtrial FibrillationArrhythmias, CardiacHeart ArrestMyocardial InfarctionCoronary DiseaseHeart FailureStrokeInfluenza, Human

Condition Hierarchy (Ancestors)

Heart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaVascular DiseasesInfarctionIschemiaNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Director, Enterprise Research Design
Organization
Evidation Health
results@evidation.com
650-389-9550

Study Officials

  • Nell Marshall, DrPh

    Evidation Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

October 14, 2020

Study Start

September 21, 2020

Primary Completion

April 12, 2021

Study Completion

April 12, 2021

Last Updated

June 21, 2022

Results First Posted

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)