Using "Decision Aids" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine
NCT ID: NCT03804489
Last Updated: 2019-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2019-01-25
2019-12-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Decision aids group
Shared decision making using decision aids,
Decision aids
Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine.
Control group
Standard oral explanation with booklet.
No interventions assigned to this group
Interventions
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Decision aids
Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. . The participants' baby who have fever or contraindication for oral rotavirus.
20 Years
80 Years
ALL
Yes
Sponsors
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Taipei Medical University Shuang Ho Hospital
OTHER
Responsible Party
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Sheng-Chieh Lin
Medical attending doctor
Principal Investigators
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Sheng-Chieh Lin, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University
Locations
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Sheng-Chieh Lin
New Taipei City, No.291, Zhongzheng Road, Zhonghe District, New Taipei City, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Lin SC, Tam KW, Yen JY, Lu MC, Chen EY, Kuo YT, Lin WC, Chen SH, Loh EW, Chen SY. The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial. Prev Med. 2020 Dec;141:106244. doi: 10.1016/j.ypmed.2020.106244. Epub 2020 Sep 4.
Other Identifiers
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108HHC-03
Identifier Type: -
Identifier Source: org_study_id
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