Improving Medication Adherence in Pediatric Inflammatory Bowel Disease
Condition: Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Colitis; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Telehealth Behavioral Treatment (TBT); Education Only (EO)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Families in the TBT condition will receive three individually-tailored behavioral intervention sessions in addition to the online education intervention with 1) guided problem-solving and behavior management training tailored to the unique needs and/or barriers of the family, and 2) discussion of the patient's adherence since the previous session. In addition, patients in the TBT condition will be signed up for text message reminder service offered free of charge via www.mymedschedule.com. These are generic reminder text messages are used to assist with adherence in adolescents. Intervention sessions will be conducted via telehealth delivery with trained postdoctoral psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software.; Families in the EO condition will receive three individual sessions in addition to the online education intervention to review 1) online educational intervention material to answer questions participants have, 2) educational brochures from the Crohn's and Colitis Foundation of America (CCFA), which contain additional information (e.g., Guide for Parents, Living with IBD, Guide for Kids and Teenagers), and 3) general healthy lifestyle recommendations (e.g., sleep, exercise, etc.). Sessions will be conducted via telehealth delivery with trained postdoctoral clinical psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment