Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061737
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2003-06-03
Brief Title:
Quality of Life in Pediatric Inflammatory Bowel Disease
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Measurement of the quality of life QoL of children and adolescents with inflammatory bowel diseases IBD has had little attention despite the importance of understanding key factors affecting QoL especially for measuring the effects of clinical trials to improve IBD outcomes The main purpose of this pilot study is to examine the impact of clinical severity and treatment social factors on the quality of life QoL of a diverse population of children and adolescents with inflammatory bowel disease IBD Secondary purposes include determining the effects of sociodemographic factors on QoL and exploring the concordance of views of parents and children of QoL The study aims are to 1 determine the associations of of clinical characteristics condition type activityseverity and treatment with specific components of general health-related quality of life and IBD-specific QoL 2 describe the effects of sociodemographic characteristics SES age and gender on these measures and 3 compare the views of different observers parent and child with IBD of the childs QoL The study will apply both general and condition-specific QoL measures among a random sample of 250 children and adolescents with IBD ages 5-18 years in six clinical sites We will obtain measures of QoL from both the child and a parent in each case The study will obtain additional data regarding the subjects clinical condition condition type severityactivity treatment including surgery age of onset and socioeconomic status household structure and income Main analyses will compare general and specific measures of QoL and examine the influence of clinical and sociodemographic variables on QoL through multivariate regression techniques We will also examine the differences in child and parent assessments of QoL The information from this study will provide a stronger base for future studies of treatment and natural history of IBD It will help to clarify the life domains that are affected by IBD and will inform interventions to improve QoL for children with IBD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: