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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03804489
Enrollment
180
Registered
2019-01-15
Start date
2019-01-25
Completion date
2019-12-25
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotavirus Vaccines

Keywords

Decision Aids; Shared decision making; Rotavirus Vaccines

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.

Interventions

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

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Decision aids

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Decisional conflictAn average of 1 month after interventionTotal score of decisional conflict scale
Decision-making difficultiesAn average of 1 month after interventionTotal score of decision-making scale

Countries

Taiwan

Contacts

Primary ContactSheng-Chieh Lin, MD
jacklinmails@yahoo.com.tw886-2-2249-0088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026