AsthmaNCT02571413
Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Allergic Rhinitis
A study testing score before teaching, score immediately after teaching and score 3 months after teaching in people with Asthma and Allergic Rhinitis, run by Nualanong Visitsunthorn at 1 site in Thailand.
Trial summary
Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS administration was created to decrease workload of health care professionals. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Rhinitis
- What is being tested?
- score before teaching, score immediately after teaching and score 3 months after teaching
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- May 2009to May 2010
- 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 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with 5 - 16 year old
- children with allergic rhinitis
Who cannot join
- history of intranasal corticosteroid use
- history of other underlying disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Administration Technique Among Thai Children With Allergic Rhinitis
Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS administration was created to decrease workload of health care professionals. The aim of this study is to compare the achievement of the children with AR in using INCS between the group which were instructed by animated cartoon-aided teaching or oral presentation without demonstration.
Read the detailed description
The study was a prospective randomized control trial in children aged 5 - 16 years with moderate to severe intermittent or persistent AR who had never used INCS. The patients were randomly divided into 2 groups; 1) Teaching how to use INCS by oral presentation and 2) by animated cartoon-aided teaching. Successful achievements were recorded when the patients were able to use INCS (all five-point checklists) correctly. If they were unable to use the INCS correctly after the first teaching, the same instruction would be repeated and the second assessment would be performed.
- Conditions
- Asthma, Allergic Rhinitis
- Being tested
- score before teaching, score immediately after teaching, score 3 months after teaching
- Keywords
- animated cartoon-aided teaching, oral presentation, allergic rhinitis, intranasal corticosteroid, how to use intranasal corticosteroid
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
score before teachingOther
score the check-point of correct INCS usage before teaching
score immediately after teachingOther
score the check-point of correct INCS usage immediately after teaching
score 3 months after teachingOther
score the check-point of correct INCS usage 3 months after teaching
| Study group | Role | What they receive |
|---|---|---|
| oral presentation | Other | Scoring the correct use of INC before, immediate after and 3 months after oral presentation without demonstration "how to use INCS" Receives: Other: score before teaching; Other: score immediately after teaching; Other: score 3 months after teaching |
| animated cartoon-aided VDO | Other | Scoring the correct use of INC before, immediate after and 3 months after animated cartoon-aided teaching "how to use INCS" Receives: Other: score before teaching; Other: score immediately after teaching; Other: score 3 months after teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of the correct method of intranasal corticosteroid administration technique before and after teaching
compare the scores before and after teaching( immediately and 3 months after)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nualanong Visitsunthorn
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Responsible party
- Sponsor-investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Nualanong Visitsunthorn, Prof, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571413
- Sponsor's protocol ID
- [Si 9091/2552(EC2)]
- Status last verified
- May 2016
- First submitted
- 11 Jan 2010
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Administration Technique Among Thai Children With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02571413
- Acronym / sponsor ID
- [Si 9091/2552(EC2)]
- Conditions
- Asthma, Allergic Rhinitis
- Keywords
- animated cartoon-aided teaching, oral presentation, allergic rhinitis, intranasal corticosteroid, how to use intranasal corticosteroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nualanong VisitsunthornUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Oct 2015 (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.
Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS administration was created to decrease workload of health care professionals. The aim of this study is to compare the achievement of the children with AR in using INCS between the group which were instructed by animated cartoon-aided teaching or oral presentation without demonstration.
Detailed description
The study was a prospective randomized control trial in children aged 5 - 16 years with moderate to severe intermittent or persistent AR who had never used INCS. The patients were randomly divided into 2 groups; 1) Teaching how to use INCS by oral presentation and 2) by animated cartoon-aided teaching. Successful achievements were recorded when the patients were able to use INCS (all five-point checklists) correctly. If they were unable to use the INCS correctly after the first teaching, the same instruction would be repeated and the second assessment would be performed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral presentation | Other | Other: score before teaching, Other: score immediately after teaching, Other: score 3 months after teachingScoring the correct use of INC before, immediate after and 3 months after oral presentation without demonstration "how to use INCS" |
| animated cartoon-aided VDO | Other | Other: score before teaching, Other: score immediately after teaching, Other: score 3 months after teachingScoring the correct use of INC before, immediate after and 3 months after animated cartoon-aided teaching "how to use INCS" |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with 5 - 16 year old
- children with allergic rhinitis
Key exclusion criteria (2 listed)
- history of intranasal corticosteroid use
- history of other underlying disease
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 |
|---|---|---|
| score before teachingscore the check-point of correct INCS usage before teaching | Other | animated cartoon-aided VDO, oral presentation |
| score immediately after teachingscore the check-point of correct INCS usage immediately after teaching | Other | animated cartoon-aided VDO, oral presentation |
| score 3 months after teachingscore the check-point of correct INCS usage 3 months after teaching | Other | animated cartoon-aided VDO, oral presentation |
Primary outcome
Scores of the correct method of intranasal corticosteroid administration technique before and after teaching
Time frame: 1 year
compare the scores before and after teaching( immediately and 3 months after)
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 3 May 2016.
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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.
Nualanong Visitsunthorn, Prof principal investigator
Mahidol 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 score before teaching, score immediately after teaching and score 3 months after teaching in people with Asthma and Allergic Rhinitis, run by Nualanong Visitsunthorn at 1 site in Thailand.
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 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: finished, as of the sponsor's last update on 3 May 2016. 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 Thailand. 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?
Scores of the correct method of intranasal corticosteroid administration technique before and after teaching (time frame: 1 year). 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 3 May 2016.