Drug AllergyNCT06399601
A Training Program of Drug Allergy for Healthcare Professionals
A study testing Drug allergy training program in people with Drug Allergy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Drug allergy is often under-recognized, yet over- (mistakenly) diagnosed, especially in Hong Kong. There is also a dire shortage of allergy specialists and facilities to tackle the overwhelming drug allergy pandemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Allergy
- What is being tested?
- Drug allergy training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Dec 2024to 16 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Registered nurses or doctors actively practicing in Hong Kong
- English speaking;
- Able to complete quizzes and questionnaires;
- Aged 18 or above
Who cannot join
- People who are unable to communicate in Cantonese or Mandarin
- People who are participating in other drug allergy training course
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Biomedical Science
Hong Kong, 000
Hei Li, MBBS, 2255 5995, liphilip@hku.hk
About this study
Official title: A Training Program of Drug Allergy for Healthcare Professionals: A Randomized Controlled Trial
Drug allergy is often under-recognized, yet over- (mistakenly) diagnosed, especially in Hong Kong. There is also a dire shortage of allergy specialists and facilities to tackle the overwhelming drug allergy pandemic. Fortunately, when trained, non-specialist physicians and nurses have demonstrated comparable capabilities in drug allergy evaluation compared to specialists. To potentially promote and propagate the role of non-specialist physicians and nurses toward drug allergy care, the investigators propose a study to investigate the impact of an intensive and focused drug allergy educational course conducted at the University of Hong Kong.
Read the detailed description
Two identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course.
Aims of the study Primary objective
- Investigate the change in knowledge among participants of a 2-day drug allergy educational course
- Investigate the change in clinical practice among participants of a 2-day drug allergy educational course
Secondary objectives
- Investigate the sustained change(s) in knowledge (if any) of participants of a 2-day drug allergy educational course
- Investigate the sustained change(s) in clinical practice (if any) of participants of a 2-day drug allergy educational course
Hypothesis The investigators hypothesize that candidates (practicing physicians and nurses) of the drug allergy course will gain knowledge on drug allergy, which in turn will influence and change their clinical practice.
- Conditions
- Drug Allergy
- Being tested
- Drug allergy training program
- Keywords
- Drug allergy
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug allergy training programOther
Two identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | wo identical didactic courses on drug allergy will be delivered. Changes in knowledge and clinical practice will be measured by serial practice questionnaires and knowledge quizzes conducted before and after the course. Group 1 will undergo the course first. Receives: Other: Drug allergy training program |
| Control group | Active comparator | Group 2 will undergo an identical course one month later. By comparing any changes in knowledge or practice between groups, this ensures that any changes in knowledge or practice were solely due to the course and not other external factors. Receives: Other: Drug allergy training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge of drug allergy as measured by the validated drug allergy questionnaire
Knowledge includes mechanism, clinical manifestations, diagnosis and management of drug allergy. A binary variable scale were used to ascertain level of the knowledge (from 0 to 1: 0, wrong; 1, right). Answers formats consisted of 4-choice questions (total 14 questions).
Measured: After the 2-day training course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start9 Dec 2024 (estimated)
- Primary completion16 Dec 2024 (estimated)
- Study completion16 Dec 2024 (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 Drug AllergyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399601
- Sponsor's protocol ID
- Drugallergy
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mak HWF, Meng J, Chung FKL, Lee JTY, Aberathna IS, Amarasekara U, Ranasinghe TND, Jayamali J, Yang Q, Zhou M, Chen L, Huang JX, Shi W, Kulkarni R, Peter JG, Trubiano JA, Jeewandara KC, Lucas M, Li PH. Bridging Global Disparities in Drug Allergy Through AI-Assisted Training for Non-Specialists: Findings From the Multinational ADAPT-2 Course. Clin Exp Allergy. 2026 Feb;56(2):137-146. doi: 10.1111/cea.70213. Epub 2026 Jan 20.
PubMed 41558734
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Training Program of Drug Allergy for Healthcare Professionals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06399601
- Acronym / sponsor ID
- Drugallergy
- Conditions
- Drug Allergy
- Keywords
- Drug allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 16 Dec 2024 (estimated)
- Study completion
- 16 Dec 2024 (estimated)
- First posted
- 6 May 2024 (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.
Drug allergy is often under-recognized, yet over- (mistakenly) diagnosed, especially in Hong Kong. There is also a dire shortage of allergy specialists and facilities to tackle the overwhelming drug allergy pandemic. Fortunately, when trained, non-specialist physicians and nurses have demonstrated comparable capabilities in drug allergy evaluation compared to specialists. To potentially promote and propagate the role of non-specialist physicians and nurses toward drug allergy care, the investigators propose a study to investigate the impact of an intensive and focused drug allergy educational course conducted at the University of Hong Kong.
Detailed description
Two identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course.
Aims of the study Primary objective
- Investigate the change in knowledge among participants of a 2-day drug allergy educational course
- Investigate the change in clinical practice among participants of a 2-day drug allergy educational course
Secondary objectives
- Investigate the sustained change(s) in knowledge (if any) of participants of a 2-day drug allergy educational course
- Investigate the sustained change(s) in clinical practice (if any) of participants of a 2-day drug allergy educational course
Hypothesis The investigators hypothesize that candidates (practicing physicians and nurses) of the drug allergy course will gain knowledge on drug allergy, which in turn will influence and change their clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Drug allergy training programwo identical didactic courses on drug allergy will be delivered. Changes in knowledge and clinical practice will be measured by serial practice questionnaires and knowledge quizzes conducted before and after the course. Group 1 will undergo the course first. |
| Control group | Active comparator | Other: Drug allergy training programGroup 2 will undergo an identical course one month later. By comparing any changes in knowledge or practice between groups, this ensures that any changes in knowledge or practice were solely due to the course and not other external factors. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Registered nurses or doctors actively practicing in Hong Kong
- English speaking;
- Able to complete quizzes and questionnaires;
- Aged 18 or above
Key exclusion criteria (2 listed)
- People who are unable to communicate in Cantonese or Mandarin
- People who are participating in other drug allergy training course
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 |
|---|---|---|
| Drug allergy training programTwo identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course. | Other | Control group, Intervention group |
Primary outcome
Change in knowledge of drug allergy as measured by the validated drug allergy questionnaire
Time frame: After the 2-day training course
Knowledge includes mechanism, clinical manifestations, diagnosis and management of drug allergy. A binary variable scale were used to ascertain level of the knowledge (from 0 to 1: 0, wrong; 1, right). Answers formats consisted of 4-choice questions (total 14 questions).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 41558734Mak HWF, Meng J, Chung FKL, Lee JTY, Aberathna IS, Amarasekara U, Ranasinghe TND, Jayamali J, Yang Q, Zhou M, Chen L, Huang JX, Shi W, Kulkarni R, Peter JG, Trubiano JA, Jeewandara KC, Lucas M, Li PH. Bridging Global Disparities in Drug Allergy Through AI-Assisted Training for Non-Specialists: Findings From the Multinational ADAPT-2 Course. Clin Exp Allergy. 2026 Feb;56(2):137-146. doi: 10.1111/cea.70213. Epub 2026 Jan 20.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug allergy training program in people with Drug Allergy, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 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 6 May 2024. 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 Hong Kong. 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 Hei Li, MBBS (2255 5995, liphilip@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge of drug allergy as measured by the validated drug allergy questionnaire (time frame: After the 2-day training course). 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 NCT06399601, 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 6 May 2024.