Informed Consent ProcessNCT01850329
A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
A study testing computed-assisted information program in people with Informed Consent Process, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ED) about risks, benefits, and alternatives to receiving procedural sedation for their… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Informed Consent Process
- What is being tested?
- computed-assisted information program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Dec 2009to 9 Sep 2014
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parents with patients under 18 years of age
- patients receive the procedural sedation and anesthesia in the emergency department
Who cannot join
- clinically unstable
- refuse to participate
- unable to understand the consent process for this study
Trial locations and contacts
1 site in 1 country.
About this study
This study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ED) about risks, benefits, and alternatives to receiving procedural sedation for their children.
- Conditions
- Informed Consent Process
- Being tested
- computed-assisted information program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed-assisted information programOther
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | No computed-assisted information program will be administered. |
| intervention | Experimental | computed-assisted information program will be administered. Receives: Other: computed-assisted information program |
What is being measured
The primary outcome is the main question the study is designed to answer.
structured questionnaire
a structured questionnaire with knowledge measure and satisfaction will be delivered to the participants for data collection.
Measured: before and immediately after the intervention when participants are in the emergency department, it is expected to take an expected average time of one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study start7 Dec 2009
- Primary completion9 Sep 2014
- Study completion9 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed Consent ProcessStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Ko Lin (980425), Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850329
- Sponsor's protocol ID
- KMUH-IRB- 980425
- Status last verified
- Apr 2017
- First submitted
- 15 Apr 2013
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department
- ClinicalTrials.gov ID
- NCT01850329
- Acronym / sponsor ID
- KMUH-IRB- 980425
- Conditions
- Informed Consent Process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 7 Dec 2009 (actual)
- Primary completion
- 9 Sep 2014 (actual)
- Study completion
- 9 Sep 2014 (actual)
- First posted
- 9 May 2013 (estimated)
- 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.
This study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ED) about risks, benefits, and alternatives to receiving procedural sedation for their children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –No computed-assisted information program will be administered. |
| intervention | Experimental | Other: computed-assisted information programcomputed-assisted information program will be administered. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Parents with patients under 18 years of age
- patients receive the procedural sedation and anesthesia in the emergency department
Key exclusion criteria (3 listed)
- clinically unstable
- refuse to participate
- unable to understand the consent process for this study
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 |
|---|---|---|
| computed-assisted information program | Other | intervention |
Primary outcome
structured questionnaire
Time frame: before and immediately after the intervention when participants are in the emergency department, it is expected to take an expected average time of one hour
a structured questionnaire with knowledge measure and satisfaction will be delivered to the participants for data collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed-assisted information program in people with Informed Consent Process, run by Kaohsiung Medical University Chung-Ho Memorial 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
structured questionnaire (time frame: before and immediately after the intervention when participants are in the emergency department, it is expected to take an expected average time of one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2017.