Rotavirus VaccinesNCT03804489
Using "Decision Aids" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine
A study testing Decision aids in people with Rotavirus Vaccines, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Vaccines
- What is being tested?
- Decision aids
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jan 2019to 25 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The one-month-old baby's family whose age is between 20 and 80 years old.
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Sheng-Chieh Lin
New Taipei City, No.291, Zhongzheng Road, Zhonghe District, New Taipei City, 23561
Sheng-Chieh Lin, MD, 886-2-2249-0088, jacklinmails@yahoo.com.tw
About this study
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.
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
Read the 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.
- Conditions
- Rotavirus Vaccines
- Being tested
- Decision aids
- Keywords
- Decision Aids; Shared decision making; Rotavirus Vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidsOther
Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Decision aids group | Experimental | Shared decision making using decision aids, Receives: Other: Decision aids |
| Control group | No intervention | Standard oral explanation with booklet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
Total score of decisional conflict scale
Measured: An average of 1 month after intervention
Decision-making difficulties
Total score of decision-making scale
Measured: An average of 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start25 Jan 2019 (estimated)
- Primary completion25 Oct 2019 (estimated)
- Study completion25 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Decision aids
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Chieh Lin, Taipei Medical University Shuang Ho Hospital
- Investigators
- Sheng-Chieh Lin, MD, Principal investigator, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804489
- Sponsor's protocol ID
- 108HHC-03
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32891678
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03804489
- Acronym / sponsor ID
- 108HHC-03
- Conditions
- Rotavirus Vaccines
- Keywords
- Decision Aids; Shared decision making; Rotavirus Vaccines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 25 Jan 2019 (estimated)
- Primary completion
- 25 Oct 2019 (estimated)
- Study completion
- 25 Dec 2019 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Decision aids
| Arm | Type | Receives |
|---|---|---|
| Decision aids group | Experimental | Other: Decision aidsShared decision making using decision aids, |
| Control group | No intervention | –Standard oral explanation with booklet. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The one-month-old baby's family whose age is between 20 and 80 years old.
Key exclusion criteria (2 listed)
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidsDecision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine. | Other | Decision aids group |
Primary outcome
Decisional conflict
Time frame: An average of 1 month after intervention
Total score of decisional conflict scale
Decision-making difficulties
Time frame: An average of 1 month after intervention
Total score of decision-making scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 32891678Lin 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.
- Individual participant dataSharing planned: Undecided
Related trials for Rotavirus Vaccines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Chieh Lin, MD principal investigator
Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aids in people with Rotavirus Vaccines, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Chieh Lin, MD (886-2-2249-0088, jacklinmails@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: An average of 1 month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03804489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.