Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Kids Itch Severity (SKIS) (SKIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672579
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Suephy Chen, MD, Emory University

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).

Condition or disease
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 312 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of Kids Itch Severity (SKIS): "Validation and Mobilization of Pediatric Pruritus Outcome Instruments"
Study Start Date : May 2015
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. ItchyQoL (KidsItchyQoL) validity [ Time Frame: Baseline ]
    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.

  5. Psychometric properties of the ItchyQuant [ Time Frame: Baseline ]
    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.

  6. ItchyQoL (TotsItchyQoL) test-retest reliability [ Time Frame: 1 hour from 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.

  7. ItchyQoL (TotsItchyQoL) test-retest reliability [ Time Frame: 6 months ]
    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.

  8. ItchyQoL (KidsItchyQoL) test-retest reliability [ Time Frame: 7 days ]
    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.

  9. ItchyQoL (KidsItchyQoL) test-retest reliability [ Time Frame: 6 months ]
    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.

  10. ItchyQoL (TotsItchyQoL) validity [ Time Frame: 1 hour from 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.

  11. ItchyQoL (TotsItchyQoL) validity [ Time Frame: 6 months ]
    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.

  12. ItchyQoL (KidsItchyQoL) validity [ Time Frame: 7 days ]
    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.

  13. ItchyQoL (KidsItchyQoL) validity [ Time Frame: 6 months ]
    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.

  14. Psychometric properties of the ItchyQuant [ Time Frame: 1 week ]
    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.

  15. Psychometric properties of the ItchyQuant [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672579


Locations
Layout table for location information
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Suephy Chen, MD Emory University
Layout table for additonal information
Responsible Party: Suephy Chen, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02672579    
Other Study ID Numbers: IRB00081076
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Pruritus
Skin Diseases
Skin Manifestations