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

Rotavirus Vaccines Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03804489
• Other study ID #: 108HHC-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 25, 2019
• Est. completion date: December 25, 2019

Study information

• Verified date: January 2019
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Sheng-Chieh Lin, MD
• Phone: 886-2-2249-0088
• Email: jacklinmails[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotavirus Vaccines

Intervention

Other:
• Decision aids
Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine.

Locations

Country	Name	City	State
Taiwan	Sheng-Chieh Lin	New Taipei City	No.291, Zhongzheng Road, Zhonghe District, New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	Total score of decisional conflict scale	An average of 1 month after intervention
Primary	Decision-making difficulties	Total score of decision-making scale	An average of 1 month after intervention