Adult patients aged 20 years or older with chronic pruritus (pruritus lasting six or more weeks) chronic pruritus disease burden health-related quality of life patient-reported outcomes psychometric properties
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 years or older at the date of screening 2. Diagnosed with chronic pruritus based on the IFSI recommendation, itch lasting more than 6 weeks 3. Could read and communicate in the Thai language 4. Had an ability to understand and willingness to sign an informed consent statement and adhere to the study protocol
Exclusion criteria
Exclusion criteria: 1. Inability to answer questions or comply with the study protocol due to both physical and mental disability 2. Recent hospitalization within 3 months 3. Prognosis for survival is less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pruritus intensity every 3 month VAS, VRA, NRA,Itch symptoms every 3 month 5-D itch scale ,Patient global assessment of pruritus control every 3 months single item NRS of 0-10 points ,Chronic pruritus: disease control every 3 month multidimensional scale for assessing disease activity control ,Satisfaction with treatment care every 3 month single item NRS of 0-10 points ,Treatment satisfaction for chronic pruritus every 3 month multidimensional scale for capturing treatment satisfaction ,Health-Related Quality of Life every 3 month DLQI, EQ-5D-5L, Self-rated health-WHO, ItchyQoL, Global rating of change in HRQoL scale ,Mental Health and psychosocial Issues every 3 month PHQ-9, GAD-7, WHO-5 well-being index, BRCS, TAS-20, PUSH-D, RSES, UCLA loneliness scale-6,Psychosomatic Symptoms every 3 month ISI-7, SSS-8, Global Fatigue, Pain intensity, MAST | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Tests every 3 month Routine blood chemistry including, complete blood count, blood sugar, tests for electrolytes, liver/renal function test, lipid profile,Healthcare costs every 6 month direct costs (medical and non-medical costs), indirect costs,Hospitalization every year All-cause hospitalization,Mortality every year All-cause mortality | — |
Countries
Thailand
Contacts
Faculty of Pharmacy, Chiang Mai University