Chronic Pruritus Clinical Trial
— SKISOfficial title:
Study of Kids Itch Severity (SKIS): "Validation and Mobilization of Pediatric Pruritus Outcome Instruments"
NCT number | NCT02672579 |
Other study ID # | IRB00081076 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | June 28, 2018 |
Verified date | August 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 312 |
Est. completion date | June 28, 2018 |
Est. primary completion date | June 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05038982 -
Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
|
Phase 2 | |
Completed |
NCT01951274 -
VPD-737 for Treatment of Chronic Pruritus
|
Phase 2 | |
Completed |
NCT04949893 -
Causes of Chronic Pruritus
|
||
Completed |
NCT03751111 -
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone
|
Phase 1/Phase 2 | |
Completed |
NCT04693195 -
A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
|
Phase 2 | |
Not yet recruiting |
NCT05678309 -
Establishment of a Patient Library in Patients With Pruritus Sine Materia
|