CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 148 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01781481
NCT01781481N/ACompleted

The Pediatric Intermed: A New Clinical Decision Making Tool for Proactive Evaluation of Psychosocial Stress in Children With Inflammatory Bowel Disease

Children's Hospital of Eastern Ontario·observational·Posted Feb 1, 2013·Updated Jul 26, 2016

In Brief

An observational study for Inflammatory Bowel Disease. Completed, enrolled 148 participants across 1 site.

Detailed Summary

The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth. The Pediatric INTERMED adopts a life-chart methodology to structure and organize complex case material in time, colour-coding domains to facilitate identification of areas of high need and risk for each patient. The focus of the present study is to examine the characteristics and usefulness of the tool in identifying psychosocial stress in children/youth diagnosed with Inflammatory Bowel Disease (IBD), as well as identifying overall case complexity. Children and parents will participate in a semi-structured structured interview with a clinical nurse who will then rate the 34-PIM items. To examine the construct validity of each of the Pediatric INTERMED domains (biological, psychological, social, caregiver/family, health care system) participants will complete questionnaires assessing social and psychological functioning, parent and family stress, quality of life and adaptive functioning. Information about disease status, and health care utilization will be obtained from medical chart review. It is hypothesized that greater case complexity will be predictive of more complex disease course/treatment, poorer quality of life, and increased health care utilization.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsJanssen Inc.

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2013
Enrollment StartApr 1, 2010
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.4 years ago