Improving Medication Adherence in Pediatric Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Indeterminate Colitis; Ulcerative Colitis; Crohn's Disease; Inflammatory Bowel Disease
• Interventions: Behavioral: Telehealth Behavioral Treatment (TBT); Behavioral: Education Only (EO)

• Registration Number: NCT01536509
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Primary Completion: 2016-05-31
• Study Completion: 2016-05-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth Behavioral Treatment	Telehealth Behavioral Treatment (TBT)	-
Education Only	Education Only (EO)	-

Primary Outcome Measures

Name	Time	Method
Medication adherence	15 months	Medication adherence will be measured using electronic monitoring. The specific device is the MEMS TrackCap. Immunomodulators and/or mesalamine medications will be assessed.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	15 months	The IMPACT III measure will be used for this assessment. This is an IBD-specific HRQOL assessment tool.
Health care utilization	15 months	Health care utilization will be assessed via medical chart review and all IBD-related hospital admissions, procedures, communications, clinic appointments, and other encounters with the health care system will serve as indicators of utilization.
Disease Severity	15 months	The Pediatric Crohn's Disease Activity Index (PCDAI) and Partial Harvey-Bradshaw Index (PHBI) will be used to assess disease severity in patients with Crohn's disease. The Pediatric Ulcerative Colitis Index (PUCAI) will be used in patients with ulcerative colitis.

Trial Locations

Locations (9)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

University of California San Francisco Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Childrens Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Oklahoma State University; 🇺🇸 Stillwater, Oklahoma, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States