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.
Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease
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.
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 CAN'T join if...
Diagnosis of pervasive developmental disorder in patient or parent
Diagnosis of serious mental illness (e.g., schizophrenia) in patient or parent
University of California San Francisco Benioff Children's Hospital San Francisco, California, 94143, United States
Oklahoma State University Stillwater, Oklahoma, 74074, United States
Children's Mercy Hospitals and Clinics Kansas City, Missouri, 64108, United States
University of Cincinnati Cincinnati, Ohio, 45221, United States
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital Columbus, Ohio, 43205, United States
Childrens Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania, 15224, United States
Children's Hospital of Philadelphia Philadelphia, Pennsylvania, 19104, United States
Connecticut Children's Medical Center Hartford, Connecticut, 06106, United States
in progress, not accepting new patients
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)