NCT02285049

Brief Summary

Chronic urticaria symptoms commonly fluctuate from day by day. Consequently the clinical presentation of a patient in each visit is not representative of the current disease status. Dermatologists are trying to integrate an evaluation process of each treatment visit regarding both clinical condition and life quality concern. The Urticaria Control Test is the key for a better treatment outcome in a routine management. To translate this questionnaire into Thai is essential in our subject of interest for offering local patients a higher well-being standard. The Thai-version test will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

October 17, 2014

Last Update Submit

February 28, 2016

Conditions

Chronic Urticaria

Keywords

Chronic urticariaUrticaria Control Test

Outcome Measures

Primary Outcomes (1)

  • Convergent validity of Thai version of Urticaria Control Test

    Compare the relationship among Urticaria Activity Score (UAS28), Patient's global assessment of disease severity (PatGA-LS), Physician's global assessment of disease control (PhyGA-LS), Dermatology Life Quality Index (DLQI) and Thai-version UCT.

    4 week

Secondary Outcomes (3)

  • Reliability of Thai version of Urticaria Control Test

    4 week

  • Interpretability of Thai version of Urticaria Control Test

    4 week

  • Screening accuracy (Responsiveness to Change) of Thai version of Urticaria Control Test

    4 week

Study Arms (1)

Urticaria Control Test

* Evaluation by UAS28, PatGA-LS, PhyGA-LS * Fill the UCT and DLQI questionnaire

Other: Urticaria Control Test

Interventions

Urticaria Control TestOTHER

* The patients get the 1st UAS28 form and four-week appointment to follow up. * Collect completed UAS28 assessment, Patient's global assessment of disease severity (PatGA-LS) and Physician's global assessment of disease control (PhyGA-LS) * Then patients fill the 1st UCT and DLQI questionnaire by themselves. * The patients get the 2nd UAS28 form and four-week appointment to follow up. * At the 2nd visit, collect completed UAS28 assessment. Assessment the severity of chronic urticaria symptoms by Patient's global assessment of disease severity (PatGA-LS) and Physician's global assessment of disease control (PhyGA-LS). The patients fill the UCT and DLQI and questionnaire by themselves.

Urticaria Control Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who were diagnosed as chronic urticaria

You may qualify if:

  • Age 18 years old or above
  • Diagnosed as chronic urticaria based on "The EAACI/GA(2) LEN/EDF/WAO Guideline: the 2013 revision and update" by dermatologists
  • Literate in Thai language and can complete the questionnaire by themselves.

You may not qualify if:

  • Have other active skin diseases
  • Have a psychiatric problem
  • Cannot understand the questionnaire by themselves.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kanokwalai Kulthanan, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2014

First Posted

November 6, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2015

Study Completion

January 1, 2016

Last Updated

March 1, 2016

Record last verified: 2016-02

Locations

TH(1)