Improving Medication Adherence in Pediatric Inflammatory Bowel Disease

Last updated: January 24, 2020
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Completed

Phase

N/A

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT01536509
R01HD067174
  • Ages 11-18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 ofCalifornia San Francisco Benioff Children's Hospital, or Children's Mercy Hospitalsand 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 duringfour week run-in phase

Exclusion

Exclusion Criteria:

  • Diagnosis of pervasive developmental disorder in patient or parent

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

Study Design

Total Participants: 140
Study Start date:
February 01, 2012
Estimated Completion Date:
May 31, 2016

Study Description

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.

Connect with a study center

  • University of California San Francisco Benioff Children's Hospital

    San Francisco, California 94143
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45221
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Oklahoma State University

    Stillwater, Oklahoma 74074
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Childrens Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

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