Improving Medication Adherence in Pediatric Inflammatory Bowel Disease

Completed · Not applicable

Conditions studied: Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Inflammatory Bowel Disease

In brief

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.

Key facts

Study ID

NCT01536509

Run by

Children's Hospital Medical Center, Cincinnati

People needed

140

Starts

2012-02-01

Expected to finish

2016-05-31

Last updated by the study team

2020-01-28

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is currently seen for care at one of the collaborating research sites: Cincinnati Children's Hospital Medical Center, Connecticut Children's Medical Center, Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of California San Francisco Benioff Children's Hospital, or Children's Mercy Hospitals and Clinics
• Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis
• Patient age between 11-18 years
• Patient currently living at home
• Patient currently prescribed at least one daily oral immunomodulator (e.g., 6-MP/azathioprine) and/or 5-ASA (e.g., mesalamine)in pill form
• English fluency for patient and parents
• Inclusion for Randomization: <90% adherence to immunomodulator and/or 5-ASA during four week run-in phase

You may not qualify if…

• Diagnosis of pervasive developmental disorder in patient or parent
• Diagnosis of serious mental illness (e.g., schizophrenia) in patient or parent

Where it is running

• University of California San Francisco Benioff Children's Hospital — San Francisco, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oklahoma State University — Stillwater, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Childrens Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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