Study of Kids Itch Severity (SKIS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chronic Pruritus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No