Using "Decision Aids" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine

Not Applicable

• Conditions: Rotavirus Vaccines
• Interventions: Other: Decision aids

• Registration Number: NCT03804489
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Last Update Submitted: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15
• Study Start: 2019-01-25
• Primary Completion: 2019-10-25
• Study Completion: 2019-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision aids group	Decision aids	Shared decision making using decision aids,

Primary Outcome Measures

Name	Time	Method
Decisional conflict	An average of 1 month after intervention	Total score of decisional conflict scale
Decision-making difficulties	An average of 1 month after intervention	Total score of decision-making scale

Trial Locations

Locations (1)

Sheng-Chieh Lin; 🇨🇳 New Taipei City, No.291, Zhongzheng Road, Zhonghe District, New Taipei City, Taiwan