Adverse Drug ReactionsKAPHWDHRCNCT04252326
The Knowledge, Attitudes and Practices of Healthcare Workers on Drug Hypersensitivity Reactions in Children
A study testing Survey in people with Adverse Drug Reactions, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Adverse drug reactions are an important public health consern that affects physician prescriptions and practice. The responsibilities of healthcare professionals in monitoring, prevention, treatment and reporting of drug hypersensitivity reactions and drug allergies are essential for patient safety. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Reactions
- What is being tested?
- Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Mar 2020
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The study included healthcare workers including medical doctors, nurses and dentists who perform interventions on children (0-18 years of age).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Sağlam Cd No:11
Ankara, Etlik, 06010
About this study
Official title: The Knowledge, Attitudes and Practices of Healthcare Workers on Drug Hypersensitivity Reactions in Children: A Tertiary Center Experience
Adverse drug reactions are an important public health consern that affects physician prescriptions and practice. The responsibilities of healthcare professionals in monitoring, prevention, treatment and reporting of drug hypersensitivity reactions and drug allergies are essential for patient safety. Providing drug safety must be one of the main goals to be achieved for every member of our society. In our study, we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients and to determine the risk factors that may affect them.
Read the detailed description
This study was carried out in a capital-located university hospital with a capacity of 1150 beds. Healthcare workers who are authorized to intervene in children (0-18 age group) including medical doctors, nurses and dentists were enrolled to study. In the evaluation of the knowledge, attitudes, and behaviors of the participants about drug hypersensitivity reactions in children, a study questionnaire was developed by pediatric allergy and immunology specialists and pediatric nurses by considering the other studies on the same subject.
- Conditions
- Adverse Drug Reactions
- Being tested
- Survey
- Keywords
- Healthcare workers, Adverse drug reactions
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Doctors, Nurses and Dentists filled survey about adverse drug reractions
| Study group | Role | What they receive |
|---|---|---|
| Doctor | Active comparator | Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children Receives: Other: Survey |
| Nurse | Active comparator | Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children Receives: Other: Survey |
| Dentist | Active comparator | Knowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients
- The knowledge level domain, consisted of 24 questions including mechanism of drug hypersensitivity reactions, clinical findings, diagnosis and treatment. The answer format was 3 options (yes/no /don't know). A triple variable scale was used for knowledge level (0 to 2: 0, false; 1, true; 2, do not know).
- The attitude domain consisted of 5 questions including the effect of DHRs on the patient's quality of life and advanced training and current diagnostic tests for the needs in this regard. A five-point Likert-type scale was used for the questions to determine the level of agreement or disagreement (1 to 5; 1 strongly disagree; 2, disagree; 3, uncertain; 4, agree; 5, strongly agree)
- The practice domain consisted of 9 questions including taking history and practice in drug allergy and advanced training in DHR. A Likert-type scale was used to determine the level of practices (1 - 5: 1, never; 2, very rarely; 3, sometimes; 4, often; 5, always).
Measured: It is planned to fill the questionnaire in 2 hours.
we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients
The knowledge level domain, consisted of 24 questions including mechanism of drug hypersensitivity reactions, clinical findings, diagnosis and treatment. The answer format was 3 options (yes/no /don't know).
- The attitude domain consisted of 5 questions including the effect of DHRs on the patient's quality of life and advanced training and current diagnostic tests for the needs in this regard. A five-point Likert-type scale was used for the questions to determine the level of agreement or disagreement The practice domain consisted of 9 questions including taking history and practice in drug allergy and advanced training in DHR. A Likert-type scale was used to determine the level of practices
Measured: It is planned to fill the questionnaire in 2 hours.
Secondary outcomes (1)
to determine the risk factors that may affect the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patient
Participants'demographic questions regarding the age, gender, profession, duration in the profession, title and educational status of the participants may effect their surveys scores
Measured: It is planned to fill the questionnaire in 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug ReactionsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı ERCAN, Saglik Bilimleri Universitesi
- Investigators
- Nazlı Ercan, MD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252326
- Sponsor's protocol ID
- DrNazlı2020
- Acronym
- KAPHWDHRC
- Status last verified
- Sep 2020
- First submitted
- 29 Jan 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dorji C, Tragulpiankit P, Riewpaiboon A, Tobgay T. Knowledge of Adverse Drug Reaction Reporting Among Healthcare Professionals in Bhutan: A Cross-Sectional Survey. Drug Saf. 2016 Dec;39(12):1239-1250. doi: 10.1007/s40264-016-0465-2.
PubMed 27743333Seid MA, Kasahun AE, Mante BM, Gebremariam SN. Healthcare professionals' knowledge, attitude and practice towards adverse drug reaction (ADR) reporting at the health center level in Ethiopia. Int J Clin Pharm. 2018 Aug;40(4):895-902. doi: 10.1007/s11096-018-0682-0. Epub 2018 Aug 9.
PubMed 30094559
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Knowledge, Attitudes and Practices of Healthcare Workers on Drug Hypersensitivity Reactions in Children: A Tertiary Center Experience
- ClinicalTrials.gov ID
- NCT04252326
- Acronym / sponsor ID
- KAPHWDHRC / DrNazlı2020
- Conditions
- Adverse Drug Reactions
- Keywords
- Healthcare workers, Adverse drug reactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Feb 2020 (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.
Adverse drug reactions are an important public health consern that affects physician prescriptions and practice. The responsibilities of healthcare professionals in monitoring, prevention, treatment and reporting of drug hypersensitivity reactions and drug allergies are essential for patient safety. Providing drug safety must be one of the main goals to be achieved for every member of our society. In our study, we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients and to determine the risk factors that may affect them.
Detailed description
This study was carried out in a capital-located university hospital with a capacity of 1150 beds. Healthcare workers who are authorized to intervene in children (0-18 age group) including medical doctors, nurses and dentists were enrolled to study. In the evaluation of the knowledge, attitudes, and behaviors of the participants about drug hypersensitivity reactions in children, a study questionnaire was developed by pediatric allergy and immunology specialists and pediatric nurses by considering the other studies on the same subject.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Doctor | Active comparator | Other: SurveyKnowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children |
| Nurse | Active comparator | Other: SurveyKnowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children |
| Dentist | Active comparator | Other: SurveyKnowledge, Attitudes and Practices on Drug Hypersensitivity Reactions in Children |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The study included healthcare workers including medical doctors, nurses and dentists who perform interventions on children (0-18 years of age).
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SurveyDoctors, Nurses and Dentists filled survey about adverse drug reractions | Other | Dentist, Doctor, Nurse |
Primary outcome
we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients
Time frame: It is planned to fill the questionnaire in 2 hours.
1. The knowledge level domain, consisted of 24 questions including mechanism of drug hypersensitivity reactions, clinical findings, diagnosis and treatment. The answer format was 3 options (yes/no /don't know). A triple variable scale was used for knowledge level (0 to 2: 0, false; 1, true; 2, do not know). 2. The attitude domain consisted of 5 questions including the effect of DHRs on the patient's quality of life and advanced training and current diagnostic tests for the needs in this regard. A five-point Likert-type scale was used for the questions to determine the level of agreement or disagreement (1 to 5; 1 strongly disagree; 2, disagree; 3, uncertain; 4, agree; 5, strongly agree) 3. The practice domain consisted of 9 questions including taking history and practice in drug allergy and advanced training in DHR. A Likert-type scale was used to determine the level of practices (1 - 5: 1, never; 2, very rarely; 3, sometimes; 4, often; 5, always).
we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients
Time frame: It is planned to fill the questionnaire in 2 hours.
The knowledge level domain, consisted of 24 questions including mechanism of drug hypersensitivity reactions, clinical findings, diagnosis and treatment. The answer format was 3 options (yes/no /don't know). 2. The attitude domain consisted of 5 questions including the effect of DHRs on the patient's quality of life and advanced training and current diagnostic tests for the needs in this regard. A five-point Likert-type scale was used for the questions to determine the level of agreement or disagreement The practice domain consisted of 9 questions including taking history and practice in drug allergy and advanced training in DHR. A Likert-type scale was used to determine the level of practices
1 secondary outcome
to determine the risk factors that may affect the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patient
Time frame: It is planned to fill the questionnaire in 2 hours.
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 21 Sep 2020.
- Background: PubMed 27743333Dorji C, Tragulpiankit P, Riewpaiboon A, Tobgay T. Knowledge of Adverse Drug Reaction Reporting Among Healthcare Professionals in Bhutan: A Cross-Sectional Survey. Drug Saf. 2016 Dec;39(12):1239-1250. doi: 10.1007/s40264-016-0465-2.
- Results publication: PubMed 30094559Seid MA, Kasahun AE, Mante BM, Gebremariam SN. Healthcare professionals' knowledge, attitude and practice towards adverse drug reaction (ADR) reporting at the health center level in Ethiopia. Int J Clin Pharm. 2018 Aug;40(4):895-902. doi: 10.1007/s11096-018-0682-0. Epub 2018 Aug 9.
- Individual participant dataSharing planned: No
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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.
Nazlı Ercan, MD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Adverse Drug Reactions, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 1 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 21 Sep 2020. 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 Turkey (Türkiye). 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?
we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients (time frame: It is planned to fill the questionnaire in 2 hours.). 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 NCT04252326, which also lists 2 linked publications.
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 21 Sep 2020.