Clinical Outcomes, Patient-Reported Outcomes, and Economic Burden for Thai People Living with Chronic Urticaria (CORE-CU) in Routine Practice: A Monocentric Prospective Longitudinal Study

Recruiting

• Conditions: Adult patients with chronic urticaria: chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), or both (co-existing of CSU and CIndU).; Chronic urticaria; Clinical outcomes; Burden; Patient-reported outcomes; Health-related quality of life

• Registration Number: TCTR20210706005
• Lead Sponsor: Pharmacoepidemiology and Statistics Research Center (PESRC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-06
• Last Update Posted: 19 August 2024
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Participants aged 18 years or over at the date of screening
2. Diagnosed with chronic urticaria based on the EAACI/GA2LEN/EDF/WAO guideline: had wheals, angioedema, or both for more than 6 weeks
3. Had an ability to understand and willingness to sign an informed consent statement

Exclusion Criteria

1. Any conditions that would interfere with the participant's ability to comply with the study protocol
2. Prognosis for survival less than 12 months
3. Primary skin disorders that could explain the pruritus or angioedema

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily Urticaria Activity Score (daily UAS), Urticaria Activity Score over 7 days (UAS7), Urticaria Control Test (UCT), Global Assessment of disease control 12 months Patient-reported: validated measurement tool,Health-related quality of life: Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), Dermatology Life Quality Index (DLQI), and EuroQoL-5 dimension-5 level (EQ-5D-5L) 12 months Patient-reported: validated measurement tool,Mental health issues: Patient Health Questionnaire 9-item (PHQ-9), Generalized Anxiety Disorder 7-item (GAD-7), and the 5-item World Health Organization Well-being Index 12 months Patient-reported: validated measurement tool,Symptoms burden: Somatic Symptom Scale 8-item (SSS-8) and Insomnia Severity Index (ISI) 12 months Patient-reported: validated measurement tool

Secondary Outcome Measures

Name	Time	Method
Safety profiles 12 months Occurrence of adverse events,Medication adherence: Medication Adherence Scale in Thais (MAST) 12 months Patient-reported: validated measurement tool,Satisfaction with care 12 months Global visual analog scale-10cm,Work impairment: Work Productivity and Activity Impairment Instrument (WPAI) 12 months Patient-reported: validated measurement tool,Healthcare utilization and economic outcomes 12 months Healthcare costs (direct medical costs, direct non-medical costs, and indirect costs), hospitalization, emergency visits, and extra/unplanned visits during the follow-up