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Trial record 3 of 4 for:    1826329 [PUBMED-IDS]

The Pediatric Intermed: A New Clinical Decision Making Tool

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ClinicalTrials.gov Identifier: NCT01781481
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
Janssen Inc.
Information provided by (Responsible Party):
Janice S.Cohen, Children's Hospital of Eastern Ontario

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Inflammatory Bowel Disease

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Children and Youth With IBD Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).

Participant Flow:   Overall Study
    Children and Youth With IBD
STARTED   148 
COMPLETED   148 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Children and youth (ages of 8-17) followed in the IBD Clinic at the Children's Hospital of Eastern ONtario with confirmed diagnoses of IBD (Crohn's disease or ulcererative colitis).

Reporting Groups
  Description
Children and Youth With IBD Children/youth (ages 8-17) with confirmed diagnoses of IBD.

Baseline Measures
   Children and Youth With IBD 
Overall Participants Analyzed 
[Units: Participants]
 148 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 14.00 
 (10.25 to 17.75) 
Gender 
[Units: Participants]
 
Female   59 
Male   89 
Region of Enrollment 
[Units: Participants]
 
Canada   148 


  Outcome Measures

1.  Primary:   Pediatric INTERMED- Complexity Index   [ Time Frame: Time of Study Participation (Completion of Pediatric INTERMED tool) ]

2.  Primary:   Correlations Between Pediatric INTERMED Domain Scores   [ Time Frame: Pediatric INTERMED scores at time of study participation ]

3.  Primary:   Pediatric INTERMED Items   [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ]

4.  Primary:   IBD Disease Severity   [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ]

5.  Primary:   Time Since IBD Diagnosis   [ Time Frame: Data collected through chart review at time of Pediatric INTERMED interview. ]

6.  Primary:   Disease Course and Treatment   [ Time Frame: Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview) ]

7.  Primary:   IBD Treatment With Immunomodulators or Anti-TNFa Medications   [ Time Frame: Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview). ]

8.  Primary:   Functional Disability Inventory   [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ]

9.  Primary:   Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.   [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ]

10.  Primary:   Child Behaviour Checklist   [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ]

11.  Primary:   Children's Depression Inventory   [ Time Frame: Administered at study entry ]

12.  Primary:   Multidimensional Anxiety Scale for Children   [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ]

13.  Primary:   Pediatric Inventory for Parents- Difficulty Score   [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ]

14.  Primary:   Family Inventory of Life Events and Changes   [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ]

15.  Primary:   Family Inventory of Resources for Management   [ Time Frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview). ]

16.  Primary:   Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning   [ Time Frame: Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis ]

17.  Primary:   Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.   [ Time Frame: Day 1 (Time of Study Participation) ]

18.  Primary:   Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.   [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ]

19.  Primary:   Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.   [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ]

20.  Primary:   Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.   [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ]

21.  Primary:   Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.   [ Time Frame: Day 1 (At time of Pediatric Intermed Interview) ]

22.  Primary:   Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators   [ Time Frame: Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis ]

23.  Primary:   Total Number of Hospital Services Involved in Child's Care.   [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ]

24.  Primary:   Number of Calls to IBD Nurse   [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ]

25.  Primary:   Number of Extra Appointments With the IBD Team   [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ]

26.  Primary:   Number of Visits to the Hospital Emergency Department   [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ]

27.  Primary:   Number of Inpatient Hospital Admissions   [ Time Frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Janice Cohen
Organization: Children's HOspital of Eastern Ontario
phone: 613-737-7600 ext 2497
e-mail: cohen@cheo.on.ca


Publications:
Lyons, JS. Communimetrics. A communication theory of measurement for human services. New York: Springer, 2009.
Han, C, Zhao N, Blank M, Gasink, C. Impact of psychiatric disorders on patients with crohn's disease: An analysis based on a healthcare claims database. Gastroenterology-Supplements 2010; 138(5), S-9.
Kathol, R.G., Perez, R., Cohen, J.S., (2010). The Integrated Case Management Model: Assisting Complex Patients Regain Physical and Mental Health, Springer Publishing Co. N,Y,.
Achenbach TM, Rescorla LA. Manual for ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families. 2001.
McCubbin H, Patterson J. Family Inventory of Life Events and changes. In McCubbin H, Thompson A, eds. Family assessment inventories for research and practice, pp 81-100. Madison.: University of Wisconsin, 1991.
McCubbin H, Comeau J. Family Inventory of Resources for Management. In McCubbin H, Thompson A, eds. Family assessment inventories for research and practice, pp. 81-100. Madison: University of Wisconsin, 1991.


Responsible Party: Janice S.Cohen, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01781481     History of Changes
Other Study ID Numbers: 09/32E
First Submitted: January 23, 2013
First Posted: February 1, 2013
Results First Submitted: July 15, 2016
Results First Posted: July 26, 2016
Last Update Posted: July 26, 2016