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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cardiovascular disorders digital intervention arm (CVD-I) | Experimental | Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination |
|
| cardiovascular disorders without digital intervention arm | No Intervention | Individuals with cardiovascular disease who receive no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted digital intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nell Marshall, DrPh | Evidation Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidation Health | San Mateo | California | 94401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29699784 | Background | 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. | |
| 29517396 | Background | 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. |
| Label | URL |
|---|---|
| CDC Seasonal Influenza Vaccine Effectiveness | View source |
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A set of existing Achievement members who previously reported meeting the inclusion criteria were tagged for study inclusion. These participants were randomized using block randomization before being offered the opportunity to complete any study activities. Participants were sent offers via the Achievement platform to complete study activities. Participants could complete any number of survey activities. Completion of intervention activities was not required for enrollment for the CVD-I group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiovascular Disorders Digital Intervention Arm (CVD-I) | Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2020 | Feb 7, 2022 |
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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.
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| Participant Completion Rate |
Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention |
| Up to 7 months |
| 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 |
| 30763298 | Background | 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. |
| 25167382 | Background | 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. |
| Background | 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/ |
| 29910118 | 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. |
| 28792867 | Background | 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. |
| 31787410 | Background | 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. |
| 17544181 | Background | 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. |
| 30630342 | Background | 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. |
| 30715278 | Background | 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. |
| Background | 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. |
| 31747789 | 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. |
| 22263004 | Background | Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4. |
| 36206046 | Derived | 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. |
| CDC Flu \& Heart Disease and Stroke | View source |
| FG001 | Cardiovascular Disorders Without Digital Intervention Arm | Individuals with cardiovascular disease who receive no intervention |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiovascular Disorders Digital Intervention Arm (CVD-I) | Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination 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. |
| BG001 | Cardiovascular Disorders Without Digital Intervention Arm | Individuals with cardiovascular disease who receive no intervention |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Participants had the option to select more than one response for Sex/Gender. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Participants had the option to select more than one response for Race/Ethnicity. | Count of Participants | Participants |
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| Has Health Insurance | Count of Participants | Participants |
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| Has a College Degree | Count of Participants | Participants |
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| Household Income ≥ 75,000 | Count of Participants | Participants |
| ||||||||||||||||
| Heart Conditions | Participants had the option to select more than one response for "Heart Conditions" | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 7 months |
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| 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 | This population consists of all individuals who are in the intervention arm and who have responded to the 3-month or 6-month survey. | Posted | Count of Participants | Participants | Up to 7 months |
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| Secondary | Participant Completion Rate | Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention | Participants in the intervention arm who received and responded to either the 3 or 6 month survey. | Posted | Count of Participants | Participants | Up to 7 months |
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| 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. | Posted | Mean | 95% Confidence Interval | Odds ratio of influenza vaccination | Up to 7 months |
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Up to 7 months
Adverse Events were not collected or assessed as part of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiovascular Disorders Digital Intervention Arm (CVD-I) | Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Cardiovascular Disorders Without Digital Intervention Arm | Individuals with cardiovascular disease who receive no intervention | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Enterprise Research Design | Evidation Health | 650-389-9550 | results@evidation.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2021 | Jun 17, 2021 | SAP_000.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D006323 | Heart Arrest |
| D009203 | Myocardial Infarction |
| D003327 | Coronary Disease |
| D006333 | Heart Failure |
| D020521 | Stroke |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| Man |
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| Other |
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| Asian |
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| Black or African American |
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| Hispanic, Latino, or Spanish |
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| Middle Eastern or North African |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Another race or ethnicity not listed here |
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| I prefer not to answer |
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| No |
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| I don't know / I'm not sure |
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| I prefer not to answer |
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| No response |
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| Atrial fibrillation |
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| Cardiac arrest |
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| Heart attack |
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| Heart failure |
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| Coronary heart disease |
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| Stroke or CVA |
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| Other cardiovascular diseases |
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| None of the above diagnoses |
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| OG003 | Participants Who Reported Influenza Vaccine After Completing 3 Interventions | Participants who Self-reported Influenza Vaccination After Study Start after interacting With 3 Intervention Messages Through Study Close |
| OG004 | Participants Who Reported Influenza Vaccine After Completing 4 Interventions | Participants who Self-reported Influenza Vaccination After Study Start after interacting With 4 Intervention Messages Through Study Close |
| OG005 | Participants Who Reported Influenza Vaccine After Completing 5 Interventions | Participants who Self-reported Influenza Vaccination After Study Start after interacting With 5 Intervention Messages Through Study Close |
| OG006 | Participants Who Reported Influenza Vaccine After Completing 6 Interventions | Participants who Self-reported Influenza Vaccination After Study Start after interacting With 6 Intervention Messages Through Study Close |
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| OG004 |
| Completion Rate of Location Finder |
Percentage of Participants that Completed the Intervention "Location Finder" |
| OG005 | Completion Rate of Date Setter | Percentage of Participants that Completed the Intervention "Date Setter" |
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The health behavior "Sees Cardiologist" as a predictor of influenza vaccination |
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