Improving Medication Adherence in Pediatric Inflammatory Bowel Disease



Status:Recruiting
Conditions:Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:11 - 18
Updated:4/21/2016
Start Date:February 2012
Contact:Kevin A Hommel, Ph.D.
Email:kevin.hommel@cchmc.org
Phone:513-803-0407

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Telehealth Enhancement of Adherence to Medication 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 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.

The purpose of the study is to test the efficacy of a telehealth behavioral treatment (TBT)
protocol to improve medication adherence in children and adolescents with IBD via a
randomized controlled clinical trial. Participants in the TBT condition will be compared to
those in an education only (EO) condition. In order to examine clinical significance of the
intervention, treatment outcomes will include disease severity, HRQOL, and health care
utilization. This randomized controlled clinical trial for nonadherence to medication
randomizes participants to either the TBT or EO intervention condition, with assessments
occurring at baseline, post-treatment, and 3-, 6-, and 12-month follow-up. Both conditions
will participate in a self-guided educational intervention during week 6 of enrollment, with
three intervention sessions at weeks 8, 10, and 12. A 4-week run-in phase immediately
preceding randomization is utilized to establish participants' baseline adherence.
Assessments will occur at week 5 (Baseline Assessment 1), week 14 (Post-treatment Assessment
2), and 3-, 6-, and 12-month post-treatment follow-up (Assessments 3, 4, and 5).
Intervention topics will differ for each condition; however, the frequency of contact is
equivalent across conditions.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Diagnosis of pervasive developmental disorder in patient or parent

- Diagnosis of serious mental illness (e.g., schizophrenia) in patient or parent
We found this trial at
9
sites
Stillwater, Oklahoma
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-803-0407
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Phone: 412-692-5180
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Pittsburgh, PA
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Kansas City, Missouri 64108
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Kansas City, MO
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San Francisco, CA
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