Overview

This trial is active, not recruiting.

Conditions crohn's disease, ulcerative colitis, indeterminate colitis, inflammatory bowel disease
Treatments telehealth behavioral treatment (tbt), education only (eo)
Phase phase 3
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date February 2012
End date July 2017
Trial size 140 participants
Trial identifier NCT01536509, R01HD067174

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
telehealth behavioral treatment (tbt)
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.
(Active Comparator)
education only (eo)
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.

Primary Outcomes

Measure
Medication adherence
time frame: 15 months

Secondary Outcomes

Measure
Health-related quality of life
time frame: 15 months
Disease Severity
time frame: 15 months
Health care utilization
time frame: 15 months

Eligibility Criteria

Male or female participants from 11 years up to 18 years old.

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

Additional Information

Official title Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease
Principal investigator Kevin Hommel, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).