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临床试验/NCT06815250
NCT06815250招募中不适用

Effectiveness of the Influenza and Tdap (Tetanus, Diphtheria, Acellular Pertussis) Vaccination Educational and Learning Module (InTroDuce-Programme) in Improving Knowledge and Future Uptake of Vaccination Among Pregnant Mothers in Primary Care Clinics: A Randomised Control Trial Secondary IDs

Universiti Putra Malaysia8 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2026年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
351
试验地点
8
主要终点
Vaccination Future Uptake

研究概览

简要总结

The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are:

Does the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinated against Influenza and Tdap? How does demographic factors, attitudes and barriers affect vaccination decisions among pregnant mothers?

Researchers will compare InTroDuce-Programme to standard care (routine antenatal care) to see if InTroDuce-Programme works to improve knowledge and future intention of pregnant mothers to be vaccinated against Influenza and Tdap. Participants will:

Receive the web-based educational module (InTroDuce-Programme), which covers the importance, safety, and effectiveness of vaccinations, as well as addressing common concerns.

Be followed up one month after the intervention. Answer questionnaires before and after the intervention to measure changes in vaccination knowledge and future intention to get vaccinated

详细描述

1.0 Background and Significance

Maternal vaccination is a crucial public health strategy to protect mothers and infants from infectious diseases like influenza and pertussis. Pregnant women face higher risks of complications due to physiological and immunological changes, with a fourfold increased likelihood of influenza-related hospitalization. Similarly, pertussis is particularly severe in infants under two months. In Malaysia, the Ministry of Health recommends influenza and Tdap vaccines during pregnancy, but uptake remains low due to safety concerns, limited provider recommendations, and access issues. Digital interventions, particularly video-based education, have shown promise in addressing vaccine hesitancy. To tackle these barriers, the InTroDuce-Programme, a comprehensive web-based educational module, has been developed to improve vaccination knowledge and uptake.

2.0 Objective

General objective: To evaluate the effectiveness of the InTroDuce-Programme in improving knowledge and future uptake of influenza and Tdap vaccination among pregnant mothers.

Specific objectives:

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
None

入排标准

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

入选标准

  • Pregnant women aged 18 years and older
  • Before or equal to 32 weeks of gestation as we need to follow-up the patients again at 36 weeks of gestation before delivery occurs.
  • Able to understand and consent to participation in the study.

排除标准

  • Pregnant women with severe anaphylactic or allergic reactions to previous dose of influenza or Tdap vaccination.
  • Non-Malaysian

研究组 & 干预措施

Control

No Intervention

Standard antenatal care

Intervention

Experimental

Influenza and Tdap Vaccination Web-based Educational and Learning Module (InTroDuce-Programme)

结局指标

主要结局

Vaccination Future Uptake

时间窗: 1 month post-intervention

Intention of future vaccine uptake of the influenza and Tdap vaccines will be assessed using questionnaire

Knowledge of Influenza and Tdap Vaccination

时间窗: 1 month post-intervention

knowledge score about the importance, safety, and benefits of vaccination (vaccine literacy) will be assessed through pre- and post-intervention questionnaire

次要结局

  • Barriers to vaccination uptake(1 month post-intervention)

研究者

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

Lau Hung Chiun

Medical Lecturer and Family Medicine Specialist

Universiti Putra Malaysia

研究点 (8)

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