Improving Medication Adherence in Pediatric Inflammatory Bowel Disease

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.

Conditions

• Crohn's Disease
• Ulcerative Colitis
• Indeterminate Colitis
• Inflammatory Bowel Disease

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Kevin Hommel, Ph.D. · Children's Hospital Medical Center, Cincinnati

• Robert Baldassano, M.D. · Children's Hospital of Philadelphia

• Wallace Crandall, M.D. · Nationwide Children's Hospital

• Francisco Sylvester, M.D. · Connecticut Children's Medical Center

• Lee Denson, M.D. · Children's Hospital Medical Center, Cincinnati

• Michele Maddux, Ph.D. · Children's Mercy Hospital Kansas City

• Melvin Heyman, M.D. · University of California San Francisco Benioff Children's Hospital

• David Keljo, M.D. · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2016-05-31

Completion

2016-05-31

Countries

• United States

Study Locations