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临床试验/NCT06600490
NCT06600490已完成不适用

Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Adults With Chronic Disease

Tor Biering-Sørensen2 个研究点 分布在 1 个国家目标入组 308,978 人开始时间: 2024年10月1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
308,978
试验地点
2
主要终点
Number of participants who received an influenza vaccine

研究概览

简要总结

In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. Conducted during the 2023/2024 influenza season, the first NUDGE-FLU-CHRONIC trial demonstrated the effectiveness of behavioral nudging letters in increasing influenza vaccination rates among adults aged 18-64 years with chronic diseases in Denmark. This present study will once again investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among adults aged 18-64 years with chronic diseases including whether the effectiveness of the previously successful strategies can be confirmed during a subsequent influenza season.

详细描述

The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons aged 18-64 years identified as eligible for free-of-charge influenza vaccination due to a chronic condition. Subjects will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10). Individuals will be randomized to 1 of 7 arms (1 usual care arm and 6 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries with the exception of information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-64 years
  • Must be registered in the Danish nationwide registries as meeting at least one of the following eligibility criteria for free-of-charge influenza vaccination in the Danish public health system:
  • Chronic lung disease
  • Chronic cardiovascular disease other than hypertension
  • Type 1 or type 2 diabetes mellitus
  • Congenital or acquired immunodeficiency
  • Impaired breathing due to muscular weakness
  • Chronic renal or hepatic insufficiency
  • Other chronic conditions with an increased risk of severe influenza as determined by the treating physician
  • Access to the official, mandatory Danish electronic mailbox system

排除标准

  • 未提供

研究组 & 干预措施

Usual Care

No Intervention

No letter

Standard Letter

Experimental

This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement

干预措施: Behavioral Economic Principles (Behavioral)

Repeated Letter

Experimental

The standard letter sent out two times instead of once

干预措施: Behavioral Economic Principles (Behavioral)

Cardiovascular Gain-Framing Letter

Experimental

Text added to the standard letter highlighting potential cardiovascular benefits of influenza vaccination

干预措施: Behavioral Economic Principles (Behavioral)

Repeated Cardiovascular Gain-Framing Letter

Experimental

The cardiovascular gain-framing letter sent out two times instead of once

干预措施: Behavioral Economic Principles (Behavioral)

Respiratory Gain-Framing Letter

Experimental

Text added to the standard letter highlighting potential respiratory disease-related benefits of influenza vaccination

干预措施: Behavioral Economic Principles (Behavioral)

Implementation Intention Prompt Letter

Experimental

Implementation intention prompt added to the standard letter

干预措施: Behavioral Economic Principles (Behavioral)

结局指标

主要结局

Number of participants who received an influenza vaccine

时间窗: Up to 3 months

次要结局

  • Time from intervention delivery to influenza vaccination(Up to 3 months)

研究者

发起方
Tor Biering-Sørensen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tor Biering-Sørensen

Professor, MD, MSc, MPH, PhD

Herlev and Gentofte Hospital

研究点 (2)

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