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

NCT03804489 | Unknown

• 1 other identifier: 108HHC-03
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Rotavirus Vaccines

Keywords

Decision Aids; Shared decision making; Rotavirus Vaccines

Outcome Measures

Primary Outcomes (2)

• Decisional conflict

  Total score of decisional conflict scale

  An average of 1 month after intervention

• Decision-making difficulties

  Total score of decision-making scale

  An average of 1 month after intervention

Study Arms (2)

Decision aids group

EXPERIMENTAL

Shared decision making using decision aids,

Other: Decision aids

Control group

NO INTERVENTION

Standard oral explanation with booklet.

Interventions

Decision aids OTHER

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

Decision aids group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Sheng-Chieh Lin

New Taipei City, No.291, Zhongzheng Road, Zhonghe District, New Taipei City, 23561, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 32891678 DERIVED

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sheng-Chieh Lin, MD

  Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Chieh Lin, MD

CONTACT

886-2-2249-0088; jacklinmails@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical attending doctor

Model Details: Decision aids

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: January 25, 2019
• Primary Completion: October 25, 2019
• Study Completion: December 25, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

TW (1)