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临床试验/NCT04584645
NCT04584645已完成不适用

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

Evidation Health1 个研究点 分布在 1 个国家目标入组 49,138 人开始时间: 2020年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49,138
试验地点
1
主要终点
Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

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

研究组 & 干预措施

cardiovascular disorders without digital intervention arm

No Intervention

Individuals with cardiovascular disease who receive no intervention

cardiovascular disorders digital intervention arm (CVD-I)

Experimental

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

干预措施: Targeted digital intervention (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Participant Completion Rate(Up to 7 months)
  • Number of Participants With Self-reported Influenza Vaccination Status as Vaccinated(Up to 7 months)
  • Self-Reported Influenza Vaccination Status Prediction(Up to 7 months)

研究者

发起方
Evidation Health
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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