Patient-Reported Outcomes Among People Living with Chronic Pruritus

• Conditions: 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

• Registration Number: TCTR20240327001
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-27
• Last Update Posted: 19 August 2024
• Study Completion: 2030-04-01

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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