Clinical trial NCT02672579: Study of Kids Itch Severity (SKIS)
Official title: Study of Kids Itch Severity (SKIS): "Validation and Mobilization of Pediatric Pruritus Outcome Instruments"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pruritus
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 312
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between the ages of 4 and 17 who have chronic pruritus (for 6 weeks or longer). The information detailed below is reflective of the pediatric population which is the primary focus of this study though the parents and clinicians will also complete surveys.

Brief summary: This purpose of this study is to validate two measures of chronic itching in kids: itch severity (ItchyQuant) and the impact on their quality of life (ItchyQoL).

Detailed description: There are many diseases that affect children where the primary symptom is pruritus. This study aims to validate an age appropriate pediatric version of the ItchyQoL, a pruritus-specific quality of life instrument, and the ItchyQuant, a self-reported itch severity scale, to better understand how pruritus affects the pediatric population. These instruments will comprehensively capture the severity and impact of pruritus in children. The physicians want to explore the opportunity to integrate patient-reported outcome measures (PROM) as a patient-reported tool in the ambulatory setting.

Eligibility criteria: Inclusion Criteria:

* Female and male patients between the ages of 4 and 17 (parents and clinicians will be older than 18 years, both male and female)
* Informed consent/assent signed and dated by the patient/parent
* Willingness and ability for the patient to commit to all follow-up visits/phone calls for the duration of the study

Exclusion Criteria:

* Inability to speak or read English
* Any other disabilities that would prevent them from completing a survey
* Unwillingness or inability for the patient to commit to all follow-up visits/phone calls for the duration of the study

Primary outcomes:
measure: ItchyQoL (TotsItchyQoL) test-retest reliability
timeFrame: Baseline
measure: ItchyQoL (KidsItchyQoL) test-retest reliability
timeFrame: Baseline
measure: ItchyQoL (TotsItchyQoL) validity
timeFrame: Baseline
measure: ItchyQoL (KidsItchyQoL) validity
timeFrame: Baseline
measure: Psychometric properties of the ItchyQuant
timeFrame: Baseline
measure: ItchyQoL (TotsItchyQoL) test-retest reliability
timeFrame: 1 hour from baseline
measure: ItchyQoL (TotsItchyQoL) test-retest reliability
timeFrame: 6 months
measure: ItchyQoL (KidsItchyQoL) test-retest reliability
timeFrame: 7 days
measure: ItchyQoL (KidsItchyQoL) test-retest reliability
timeFrame: 6 months
measure: ItchyQoL (TotsItchyQoL) validity
timeFrame: 1 hour from baseline
measure: ItchyQoL (TotsItchyQoL) validity
timeFrame: 6 months
measure: ItchyQoL (KidsItchyQoL) validity
timeFrame: 7 days
measure: ItchyQoL (KidsItchyQoL) validity
timeFrame: 6 months
measure: Psychometric properties of the ItchyQuant
timeFrame: 1 week
measure: Psychometric properties of the ItchyQuant
timeFrame: 2 weeks
Secondary outcomes:
measure: Feasibility of harnessing an electronic platform as assessed by researcher judgement
timeFrame: 1 year from baseline
measure: Prevalence of ADHD symptoms
timeFrame: Baseline
measure: Prevalence of ADHD symptoms
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Suephy Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: