Using "SDM With PDAs" to Help Infant Family to Decide the Third Primary Dosing Pneumococcal Conjugate Vaccine
October 10, 2022 updated by: Taipei Medical University Shuang Ho Hospital
Using "Share Decision Making With Patient Decision Aids" to Help the Infant Family to Decide Whether the Baby Will Receive the Third Primary Dosing Pneumococcal Conjugate Vaccine
Pneumococcal infection is one the common infectious disease in the world.
Pneumococcal conjugate vaccine may decrease the incidence of pneumococcal infection.
In Taiwan, infants usually received 2 primary dosing pneumococcal conjugate vaccines .
The third primary dose of pneumococcal conjugate vaccine is still not included in public health insurance.
Some infants in Taiwan did not receive the third primary dose of pneumococcal vaccine.
Share decision making (SDM) with patient decision aids (PDA) provide information to infant family and to help them in making decisions about their baby's vaccination.
We develop a PDA administered for baby's family to decide whether the baby will receive the third primary dosing pneumococcal conjugate vaccine.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Pneumococcal infection is one of the most major infectious disease that cause morbidity and mortality due to pneumonia, meningitis, acute otitis media, acute rhinosinusitis and septicemia.
Although pneumococcal infection may affect people in all ages, children below 5-year-old and adults over 65-year-old are high risk group.
Pneumococcal conjugate vaccine has decreased the incidence of pneumococcal infection in the world.
Infants usually received 2 primary dosing pneumococcal conjugate vaccines on schedule in Taiwan.
The third primary dose of pneumococcal conjugate vaccine is still not included in public health insurance.
Many infants' family did not know the information of the third primary dosing pneumococcal conjugate vaccine; and not all of the infants in Taiwan received the third primary dose of pneumococcal vaccine.
Share decision making (SDM) with patient decision aids (PDA) is one way to provide information to infants' family and to help them in making decisions about their baby's vaccination.
We develop a PDA administered for baby's family to decide whether the baby will receive the third primary dosing pneumococcal conjugate vaccine.
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
The 4-month-old baby's family aged between 20 and 80 years old.
Exclusion Criteria:
The baby's family is not suitable; baby's family cannot understand languages what we said; the participants' baby who have fever or contraindication for self-paid third primary PCV.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient decision aids group
shared decision making with using patient decision aids.
(SDM group)
|
Patient Decision Aids (PDA) administer to case group
|
|
No Intervention: Control group
oral explanation.
(Non-SDM group)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decisional conflict
Time Frame: An average of ３month after intervention
|
Total scores of decisional conflict scale
|
An average of ３month after intervention
|
|
Decision-making difficulties
Time Frame: An average of ３month after intervention
|
Total scores of decision-making scale
|
An average of ３month after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of the infant's families let baby receiving third primary PCV
Time Frame: An average of ３month after intervention
|
vaccination rate
|
An average of ３month after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2022
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
October 10, 2022
First Submitted That Met QC Criteria
October 10, 2022
First Posted (Actual)
October 13, 2022
Study Record Updates
Last Update Posted (Actual)
October 13, 2022
Last Update Submitted That Met QC Criteria
October 10, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 111HHC-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.