Study of Kids Itch Severity (SKIS) (SKIS)

Study of Kids Itch Severity (SKIS): "Validation and Mobilization of Pediatric Pruritus Outcome Instruments"

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).

Study Overview

• Status: Completed
• Conditions: Chronic Pruritus

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.

• Study Type: Observational
• Enrollment (Actual): 312

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Children 4-7 years; Pediatric subjects between the ages of 4 and 7 who have had pruritus for 6 weeks or longer will complete surveys to assess the severity of pruritus.
Children 8-17 years; Pediatric subjects between the ages of 8 and 17 who have had pruritus for 6 weeks or longer will complete surveys to assess the severity of pruritus.
Parents; Parents of pediatric subjects between the ages of 4-17 years with chronic pruritus (for 6 weeks or longer) will complete surveys to assess their perception of their child's severity of pruritus.
Clinicians; Clinicians treating pediatric subjects between the ages of 4-17 years with chronic pruritus (for 6 weeks or longer) will complete surveys to assess their perception of the child's severity of pruritus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ItchyQoL (TotsItchyQoL) test-retest reliability	Subjects in the 4-7 year age group will complete the TotsItchyQoL® questionnaire. This questionnaire has a total of 16 items with cartoons accompanying each question. The interviewer will ask the subjects questions to rate how pruritus affected their quality of life (QOL). The test-retest reliability will be assessed by analyzing the recorded responses to assess improvement, no change, or worsening of their pruritus.	Baseline
ItchyQoL (KidsItchyQoL) test-retest reliability	Subjects in the 8-17 year age group will complete the KidsItchyQoL® questionnaire. This is a 27-item questionnaire where the subjects are asked to rate how pruritus affected their quality of life (QOL). The test-retest reliability will be assessed by analyzing the recorded responses to assess improvement, no change, or worsening of their pruritus.	Baseline
ItchyQoL (TotsItchyQoL) validity	Subjects in the 4-7 year age group will complete the TotsItchyQoL® questionnaire. There are a total of 16 items with cartoons accompanying each question. The subjects will be asked to rate the severity of their pruritus and the responses will be recorded. Each response will be scored and the scores will be compared across pruritus severity; mild,moderate or severe; to assess the validity of the questionnaire.	Baseline
ItchyQoL (KidsItchyQoL) validity	Subjects in the 8-17 year age group will complete the TotsItchyQoL® questionnaire. There are a total of 16 items with cartoons accompanying each question. The subjects will be asked to rate the severity of their pruritus and the responses will be recorded. Each response will be scored and the scores will be compared across pruritus severity; mild,moderate or severe; to assess the validity of the questionnaire.	Baseline
Psychometric properties of the ItchyQuant	Age-appropriate ItchyQuant will be administered as follows; subjects 4-5 years will use the modified 3-point ItchyQuant, for subjects 6-7 years, the 3-point and 5-point ItchyQuant and for ages 8 and older, the traditional non-cartoon version of the numeric rating scale (NRS) will be administered. The parent and clinician will also be asked to rate their perceived itch severity on a full-cartoon version of the ItchyQuant. The ItchyQuant is a 10-point numeric rating scale to rate itch severity. The items are scored from 0-10, where 0=no itch and 10= worst imaginable itch. The validity of the ItchyQuant will be assessed by comparing the responses.	Baseline
ItchyQoL (TotsItchyQoL) test-retest reliability	Subjects in the 4-7 year age group will complete the TotsItchyQoL® questionnaire. This questionnaire has a total of 16 items with cartoons accompanying each question. The interviewer will ask the subjects questions to rate how pruritus affected their quality of life (QOL). The test-retest reliability will be assessed by analyzing the recorded responses to assess improvement, no change, or worsening of their pruritus.	1 hour from baseline
ItchyQoL (TotsItchyQoL) test-retest reliability	Subjects in the 4-7 year age group will complete the TotsItchyQoL® questionnaire. This questionnaire has a total of 16 items with cartoons accompanying each question. The interviewer will ask the subjects questions to rate how pruritus affected their quality of life (QOL). The test-retest reliability will be assessed by analyzing the recorded responses to assess improvement, no change, or worsening of their pruritus.	6 months
ItchyQoL (KidsItchyQoL) test-retest reliability	Subjects in the 8-17 year age group will complete the KidsItchyQoL® questionnaire. This is a 27-item questionnaire where the subjects are asked to rate how pruritus affected their quality of life (QOL). The test-retest reliability will be assessed by analyzing the recorded responses to assess improvement, no change, or worsening of their pruritus.	7 days
ItchyQoL (KidsItchyQoL) test-retest reliability	Subjects in the 8-17 year age group will complete the KidsItchyQoL® questionnaire. This is a 27-item questionnaire where the subjects are asked to rate how pruritus affected their quality of life (QOL). The test-retest reliability will be assessed by analyzing the recorded responses to assess improvement, no change, or worsening of their pruritus.	6 months
ItchyQoL (TotsItchyQoL) validity	Subjects in the 4-7 year age group will complete the TotsItchyQoL® questionnaire. There are a total of 16 items with cartoons accompanying each question. The subjects will be asked to rate the severity of their pruritus and the responses will be recorded. Each response will be scored and the scores will be compared across pruritus severity; mild,moderate or severe; to assess the validity of the questionnaire.	1 hour from baseline
ItchyQoL (TotsItchyQoL) validity	Subjects in the 4-7 year age group will complete the TotsItchyQoL® questionnaire. There are a total of 16 items with cartoons accompanying each question. The subjects will be asked to rate the severity of their pruritus and the responses will be recorded. Each response will be scored and the scores will be compared across pruritus severity; mild,moderate or severe; to assess the validity of the questionnaire.	6 months
ItchyQoL (KidsItchyQoL) validity	Subjects in the 8-17 year age group will complete the TotsItchyQoL® questionnaire. There are a total of 16 items with cartoons accompanying each question. The subjects will be asked to rate the severity of their pruritus and the responses will be recorded. Each response will be scored and the scores will be compared across pruritus severity; mild,moderate or severe; to assess the validity of the questionnaire.	7 days
ItchyQoL (KidsItchyQoL) validity	Subjects in the 8-17 year age group will complete the TotsItchyQoL® questionnaire. There are a total of 16 items with cartoons accompanying each question. The subjects will be asked to rate the severity of their pruritus and the responses will be recorded. Each response will be scored and the scores will be compared across pruritus severity; mild,moderate or severe; to assess the validity of the questionnaire.	6 months
Psychometric properties of the ItchyQuant	Age-appropriate ItchyQuant will be administered as follows; subjects 4-5 years will use the modified 3-point ItchyQuant, for subjects 6-7 years, the 3-point and 5-point ItchyQuant and for ages 8 and older, the traditional non-cartoon version of the numeric rating scale (NRS) will be administered. The parent and clinician will also be asked to rate their perceived itch severity on a full-cartoon version of the ItchyQuant. The ItchyQuant is a 10-point numeric rating scale to rate itch severity. The items are scored from 0-10, where 0=no itch and 10= worst imaginable itch. The validity of the ItchyQuant will be assessed by comparing the responses.	1 week
Psychometric properties of the ItchyQuant	Age-appropriate ItchyQuant will be administered as follows; subjects 4-5 years will use the modified 3-point ItchyQuant, for subjects 6-7 years, the 3-point and 5-point ItchyQuant and for ages 8 and older, the traditional non-cartoon version of the numeric rating scale (NRS) will be administered. The parent and clinician will also be asked to rate their perceived itch severity on a full-cartoon version of the ItchyQuant. The ItchyQuant is a 10-point numeric rating scale to rate itch severity. The items are scored from 0-10, where 0=no itch and 10= worst imaginable itch. The validity of the ItchyQuant will be assessed by comparing the responses.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of harnessing an electronic platform as assessed by researcher judgement	The feasibility of an electronic platform for instruments such that mobile technology (i.e., tablets and smartphones) can be utilized in the field to capture the data will be assessed by the researchers. This electronic platform will be able to store and download the data both in summary format (total scores) as well as item level format, capture data across multiple time points, and deposit data into a variety of queryable databases such as spreadsheets, electronic data capture systems.	1 year from baseline
Prevalence of ADHD symptoms	The prevalence of symptoms of Attention Deficit Hyperactivity Disorder (ADHD) will be assessed by the ADHD screening questionnaire.This consists of an 18-item scale and each item is scored on a 0 to 3 scale, with 0= never or rarely; 1=mild (sometimes), 2=moderate (often); 3=severe (very often). The total score is computed as the sum of the scores on each item. Higher scores indicate increased severity of symptoms.	Baseline
Prevalence of ADHD symptoms	The prevalence of symptoms of Attention Deficit Hyperactivity Disorder (ADHD) will be assessed by the ADHD screening questionnaire.This consists of an 18-item scale and each item is scored on a 0 to 3 scale, with 0= never or rarely; 1=mild (sometimes), 2=moderate (often); 3=severe (very often). The total score is computed as the sum of the scores on each item. Higher scores indicate increased severity of symptoms.	2 weeks

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Suephy Chen, MD, Emory University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 11, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: IRB00081076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No