Quality of Life of Patients With a History of Drug Allerg... | NCT01666470

Studies
Quality of Life of Patients With a History of Drug Allergy in Thailand

NCT01666470

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Feb 18, 2019Actual

Enrollment

306Actual

Phase

Not provided

Conditions

Quality of Life

Interventions

Questionnaires

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012Actual

Primary Completion Date

Aug 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Aug 12, 2012

First Submission Date that Met QC Criteria

Aug 14, 2012

First Posted Date

Aug 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2019

Last Update Posted Date

Feb 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jettanong Klaewsongkram, Head of Division of Allergy and Clinical Immunology, Department of Medicine, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Name	Class
Mahidol University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Quality of life of patients with a history of drug allergy in Thailand will be studied.

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

306Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug allergy patients		Patients with a history of drug allergy in Thailand	Other: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Other	DrHy-Q (Thai version) and WHOQOL-BREF-THAI will be asked	Drug allergy patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The quality of life of Thai patients with a history of drug allergy evaluating by DrHy-Q (Thai version)		1 year

Secondary Outcomes

Measure	Description	Time Frame
The correlation between DrHy-Q (Thai version) and WHOQOL-BREF-THAI	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.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a history of drug allergy
At least 18 years of age

Exclusion Criteria:

Not be able to understand Thai language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Thai patients with a history of drug allergy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jettanong Klaewsongkram, MD	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Chulalongkorn University		Bangkok		10330	Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University

References Module

Citations

Not provided

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms