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临床试验/NCT03804489
NCT03804489Unknown不适用

Using "Decision Aids" to Help the Infant Family to Decide Whether the Baby Will Receive the Self-paid Oral Rotavirus Vaccine: A Randomized Controlled Trial.

Taipei Medical University Shuang Ho Hospital2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
2
主要终点
Decisional conflict

研究概览

简要总结

Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination. We developed a DA administered after consultation for baby's family deciding on whether the baby will receive the self-paid oral rotavirus vaccine

详细描述

Background:

Acute gastroenteritis is one of the most common infectious diseases and still a major cause of pediatric morbidity and mortality worldwide. Rotavirus was still the major cause of acute gastroenteritis in infants and young children worldwide, including in Taiwan. The World Health Organization has recommended rotavirus vaccine, which became available in 2006, for all countries. However, not all of children in Taiwan received rotavirus vaccination. Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination. We developed a DA administered after consultation for baby's family deciding on whether the baby will receive the self-paid oral rotavirus vaccine Patients and Methods Decision aids are interventions designed to help infant family make choices among options by providing information relevant to oral rotavirus vaccine. Infant coming to receiving regular routine vaccination at 1 month old are randomly assigned to receive a DA or the standard oral conversation (control condition) after the initial consultation. Infant family complete interview-based questionnaires 1 month later when they came back to hospital receiving 2-month-old regular routine vaccination and decide to receive self-paid oral rotavirus vaccine or not at that time. Primary outcome measures: decisional conflict and decision-making difficulties at 2-month-old.

Results and Conclusion The DA group are predicted to lower decisional conflict scores when compared with the control group. Our study hopes to support the efficacy of DA in helping the infant family to decide whether the baby will receive the self-paid oral rotavirus vaccine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The one-month-old baby's family whose age is between 20 and 80 years old.

排除标准

  • . The doctor determines that the baby's family is not suitable; if baby's family cannot understand Chinese languages what we said.
  • . The participants' baby who have fever or contraindication for oral rotavirus.

研究组 & 干预措施

Decision aids group

Experimental

Shared decision making using decision aids,

干预措施: Decision aids (Other)

Control group

No Intervention

Standard oral explanation with booklet.

结局指标

主要结局

Decisional conflict

时间窗: An average of 1 month after intervention

Total score of decisional conflict scale

Decision-making difficulties

时间窗: An average of 1 month after intervention

Total score of decision-making scale

次要结局

未报告次要终点

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng-Chieh Lin

Medical attending doctor

Taipei Medical University Shuang Ho Hospital

研究点 (2)

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