A Digital Flu Intervention for People With Cardiovascular Conditions (CardioFlu)
2022年5月23日 更新者：Evidation Health
Increasing Influenza Vaccination in Individuals With Cardiovascular Conditions: Assessing the Effectiveness of a Digital Intervention in a Decentralized Randomized Controlled Trial
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
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
49138
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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San Mateo、California、美国、94401
- Evidation Health
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：cardiovascular disorders digital intervention arm (CVD-I)
Individuals with cardiovascular disease who receive a targeted digital intervention aimed at increasing influenza vaccination
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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.
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无干预：cardiovascular disorders without digital intervention arm
Individuals with cardiovascular disease who receive no intervention
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
大体时间：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.
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Up to 7 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated
大体时间：Up to 7 months
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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
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Up to 7 months
|
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Participant Completion Rate
大体时间：Up to 7 months
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Differences in completion rates of specific intervention types by individuals in the group receiving the targeted intervention
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Up to 7 months
|
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Self-Reported Influenza Vaccination Status Prediction
大体时间：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.
|
Up to 7 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nell Marshall, DrPh、Evidation Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Zhong B. How to calculate sample size in randomized controlled trial? J Thorac Dis. 2009 Dec;1(1):51-4.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年9月21日
初级完成 (实际的)
2021年4月12日
研究完成 (实际的)
2021年4月12日
研究注册日期
首次提交
2020年9月15日
首先提交符合 QC 标准的
2020年10月6日
首次发布 (实际的)
2020年10月14日
研究记录更新
最后更新发布 (实际的)
2022年6月21日
上次提交的符合 QC 标准的更新
2022年5月23日
最后验证
2022年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.