CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Telephone and email correspondence with an Inflammatory Bowel Disease Nurse +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02085083
NCT02085083N/ACompleted

Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease

Mount Sinai Hospital, Canada·interventional·Posted Mar 12, 2014·Updated Apr 17, 2018

In Brief

A clinical study evaluating Telephone and email correspondence with an Inflammatory Bowel Disease Nurse and Minimal Intervention Arm for Inflammatory Bowel Disease and 2 related conditions. Completed, enrolled 150 participants across 3 sites.

Detailed Summary

The transition from pediatric to adult IBD care can be stressful and wrought with challenges including access to care and establishment of new physician-patient relationships. There a few studies which characterize patterns of healthcare utilization during this critical period and its impact on outcomes. We hypothesize that uninterrupted healthcare utilization in academic centers and optimized communication with patients during the pediatric-adult transition period is associated with lower hospitalizations and surgery. This hypothesis will be addressed by a randomized clinical trial to determine the impact of monthly regular telephone contact with an IBD Registered Nurse versus standard of care during the pediatric-adult transition period. Outcomes will include healthcare utilization, health-related quality of life, patient satisfaction, and treatment adherence over 12 months of follow-up. Randomization and analyses will be stratified by whether subjects were transferred to adult care in an academic center or in a community practice. We hope that this research will facilitate optimal delivery of healthcare during the pediatric-adult transition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 12, 2014
Enrollment StartJul 1, 2014
Primary CompletionNov 1, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.3 years ago

Interventions

Telephone and email correspondence with an Inflammatory Bowel Disease Nursebehavioral

The IBD pediatric-adult transition nurse will send an email each month containing: Brief Questionnaire: A link to a secured website will be provided where participants will respond to a questionnaire. Direct Nurse Contact: Telephone and email correspondence with an Inflammatory Bowel Disease Nurse Educational module: Every other month, we will include in the email another link to an optional educational module that will be part of a curriculum to facilitate transition readiness. MyHealth Passport Study Questionnaire: A personalized link to a more comprehensive study questionnaire similar to the baseline questionnaire will be emailed in the 6th and 12th (final) email.

Minimal Intervention Armbehavioral

Patients randomized to the control group will have receive email based questionnaires and information relating to the MyHealth Passport application. This intervention is not expected to significantly improve outcomes.