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
Conditions
Interventions
Adult patients with diagnosed chronic urticaria (duration more than 6 weeks) based on the EAACI/GA2LEN/EDF/WAO Guideline on urticaria.
Treatment
Chronic urticaria
Sponsors
Pharmacoepidemiology and Statistics Research Center (PESRC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactSurapon Nochaiwong
Pharmacoepidemiology and Statistics Research Center (PESRC)
Outcome results
None listed