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临床试验/NCT07269028
NCT07269028已完成不适用

Personalised and Gamification-based Decision Aid (DA): a Randomized Controlled Pilot Study About Colorectal Cancer (CRC) Screening

University of Pavia2 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2023年5月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
248
试验地点
2
主要终点
Awareness

研究概览

简要总结

Colorectal cancer (CRC) is the second leading cause of cancer-related mortality worldwide, accounting for approximately 903,000 deaths annually. While population-based screening programmes have demonstrated effectiveness in enhancing early detection and reducing mortality, participation rates remain suboptimal. Adherence is influenced by cognitive, psychological, and socioeconomic barriers.

This study aimed to assess the impact of a digital decision aid (DA), incorporating personalisation and gamification elements, on informed decision-making and adherence to CRC screening.

DA-CRC is a two-arm randomised controlled pilot trial. Individuals born in 1973-1974 living in the area served by the local health authority of Brescia (Northern Italy) who were invited for the first time to participate in the CRC screening programme, were eligible. An invitation letter, including instructions to download the PREVenGO app, was mailed to potential participants.

Upon download, participants were randomised to either the intervention or control arm. The intervention app included questionnaires on family history, knowledge of primary and secondary prevention, and locus of control (LoC), as well as gamification and reward features. The control app provided static educational content only. Notifications prompted users to complete follow-up assessments at 3 months (T1) and 6 months (T2), receive prevention information, and attend screening.

研究设计

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

入排标准

年龄范围
50 Years 至 51 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Stable residence within one of the municipalities served by Brescia LHA;
  • Ownership of a smartphone (Android or iOS);
  • Proficiency in the Italian language;
  • Provision of informed consent within the PREVenGO app.

排除标准

  • Failure to provide informed consent.

结局指标

主要结局

Awareness

时间窗: From enrollment to 6 months

Informed choice, using the three-dimensional model by Marteau, including: Knowledge (minimum score 7/13); Attitude (score \>24); Behavioural intention (actual participation).

次要结局

  • Uptake of CRC screening(From enrollment to 31st December 2024)
  • Knowledge of primary prevention and healthy behaviours,(From enrollment to 6 months)
  • Decisional conflict, user satisfaction, and app acceptability(From enrollment to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Montomoli

Full Professor

University of Pavia

研究点 (2)

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