Quality of Life of Patients With a History of Drug Allergy in Thailand
This study is currently recruiting participants.
Verified September 2012 by Chulalongkorn University
Sponsor:
Chulalongkorn University
Collaborators:
Mahidol University
Phramongkutklao College of Medicine
Information provided by (Responsible Party):
Jettanong Klaewsongkram, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01666470
First received: August 12, 2012
Last updated: September 5, 2012
Last verified: September 2012
| Tracking Information | |||||
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| First Received Date ICMJE | August 12, 2012 | ||||
| Last Updated Date | September 5, 2012 | ||||
| Start Date ICMJE | August 2012 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The quality of life of Thai patients with a history of drug allergy evaluating by DrHy-Q (Thai version) [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01666470 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The correlation between DrHy-Q (Thai version) and WHOQOL-BREF-THAI [ Time Frame: 1 year ] [ Designated as safety issue: No ] Pearson correlation coefficient between scores from DrHy-Q (Thai version) and WHOQOL-BREF-THAI in patients with a history of drug allergy will be analyzed. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality of Life of Patients With a History of Drug Allergy in Thailand | ||||
| Official Title ICMJE | Quality of Life of Patients With a History of Drug Allergy in Thailand | ||||
| Brief Summary | Quality of life of patients with a history of drug allergy in Thailand will be studied. |
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| Detailed Description | Thai patients with a history of drug allergy will be evaluated for their quality of life based on drug hypersensitivity quality of life questionnaire (DrHy-Q; Thai version) and The World Health Organization Quality of Life instrument (WHOQOL-BREF-THAI) |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Thai patients with a history of drug allergy |
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| Condition ICMJE | Quality of Life | ||||
| Intervention ICMJE | Other: Questionnaires
DrHy-Q (Thai version) and WHOQOL-BREF-THAI will be asked |
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| Study Group/Cohort (s) | Drug allergy patients
Patients with a history of drug allergy in Thailand
Intervention: Other: Questionnaires |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01666470 | ||||
| Other Study ID Numbers ICMJE | Chula-ARC 001/12 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jettanong Klaewsongkram, Chulalongkorn University | ||||
| Study Sponsor ICMJE | Chulalongkorn University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Chulalongkorn University | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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