Clinical Trial: Study of Kids Itch Severity (SKIS)

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

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 Summary: 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.
Sponsor: Emory University

Current Primary Outcome:

  • ItchyQoL (TotsItchyQoL) test-retest reliability [ Time Frame: Baseline ]
    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.
  • ItchyQoL (KidsItchyQoL) test-retest reliability [ Time Frame: Baseline ]
    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.
  • ItchyQoL (TotsItchyQoL) validity [ Time Frame: Baseline ]
    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.
  • ItchyQoL (KidsItchyQoL) validity [ Time Frame: Baseline ]
    Subjects in the 8-17 year age group will complete the TotsItchyQoL® questionnaire. T

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Feasibility of harnessing an electronic platform as assessed by researcher judgement [ Time Frame: 1 year from baseline ]
      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.
    • Prevalence of ADHD symptoms [ Time Frame: Baseline ]
      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.
    • Prevalence of ADHD symptoms [ Time Frame: 2 weeks ]
      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.


    Original Secondary Outcome: Same as current

    Information By: Emory University

    Dates:
    Date Received: December 15, 2015
    Date Started: May 2015
    Date Completion: May 2017
    Last Updated: July 21, 2016
    Last Verified: July 2016