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NCT01536509 · ClinicalTrials.gov registry record · NA
Improving Medication Adherence in Pediatric Inflammatory Bowel Disease
A NA study of Ulcerative Colitis and Crohn's Disease, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 9
- Study locations
NCT01536509: Completed NA study of Ulcerative Colitis and Crohn's Disease, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01536509 is a NA study of Ulcerative Colitis and Crohn's Disease that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 140 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (93% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01536509, a NA study of Ulcerative Colitis and Crohn's Disease, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of the study is to test an online behavioral intervention to improve medication adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be monitored for four weeks to determine how frequently their child's IBD medication is taken. Patient's taking less than 90% of medications will be randomized to one of two intervention conditions to complete intervention sessions online. The study consists of 4 online intervention sessions with topics differing by condition and 5 online assessments to complete quality of life questionnaires over a 14 month time frame.
Primary Outcome
Medication adherence will be measured using electronic monitoring. The specific device is the MEMS TrackCap. Immunomodulators and/or mesalamine medications will be assessed.
Conditions Studied
Interventions
- BEHAVIORAL Telehealth Behavioral Treatment (TBT)
- BEHAVIORAL Education Only (EO)
Study Locations (9)
Ohio
- University of Cincinnati - Cincinnati
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Childrens Hospital of Pittsburgh of UPMC - Pittsburgh
California
- University of California San Francisco Benioff Children's Hospital - San Francisco
Connecticut
- Connecticut Children's Medical Center - Hartford
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
Oklahoma
- Oklahoma State University - Stillwater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-05-31 |
| Phase | NA |
What the finished NCT01536509 record still lists
NCT01536509 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Telehealth Behavioral Treatment (TBT) is the first listed.
NCT01536509 lists 9 locations in 6 states (Ohio, Pennsylvania, California).
Frequently Asked Questions
What is clinical trial NCT01536509 about?
NCT01536509 is a clinical study titled "Improving Medication Adherence in Pediatric Inflammatory Bowel Disease". The purpose of the study is to test an online behavioral intervention to improve medication adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be monitored for four weeks to determine how frequently their child's IBD medication is taken. Patient's taking less t...
What is the current status of trial NCT01536509?
This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2012-02. Estimated completion is 2016-05-31.
What conditions does trial NCT01536509 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease, Indeterminate Colitis.
What interventions are being tested in trial NCT01536509?
The interventions under investigation include: Telehealth Behavioral Treatment (TBT) (BEHAVIORAL), Education Only (EO) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01536509?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01536509 being conducted?
This trial has 9 study locations across California, Connecticut, Missouri, Ohio, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01536509's enrollment target sits among peer trials
140 51st of 122 higher than 71 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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