Study of Kids Itch Severity (SKIS)

Emory University

Status: Completed

Conditions: Chronic Pruritus

Study type: Observational

Funder types: Other

Identifiers

NCT02672579

IRB00081076

Details and patient eligibility

About

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).

Full 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.

Enrollment: 312 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

312 participants in 4 patient groups

Children 4-7 years

Description:

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

Description:

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

Description:

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

Description:

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.