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Improving Medication Adherence in Pediatric Inflammatory Bowel Disease (TEAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Kevin Hommel, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01536509
First received: February 16, 2012
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Inflammatory Bowel Disease
Behavioral: Telehealth Behavioral Treatment (TBT)
Behavioral: Education Only (EO)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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:
  • Health-related quality of life [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    The IMPACT III measure will be used for this assessment. This is an IBD-specific HRQOL assessment tool.

  • Disease Severity [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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.

  • Health care utilization [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 194
Study Start Date: February 2012
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telehealth Behavioral Treatment 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.
Active Comparator: Education Only 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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536509

Contacts
Contact: Kevin A Hommel, Ph.D. 513-803-0407 kevin.hommel@cchmc.org
Contact: Katherine L Loreaux, B.A. 513-803-1009 katherine.loreaux@cchmc.org

Locations
United States, California
University of California San Francisco Benioff Children's Hospital Recruiting
San Francisco, California, United States, 94143
Contact: Melvin Heyman, M.D.       mheyman@peds.ucsf.edu   
Sub-Investigator: Melvin Heyman, M.D.         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Francisco Sylvester, M.D.       fsylves@ccmckids.org   
Sub-Investigator: Francisco Sylvester, M.D.         
United States, Missouri
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Michele Maddux, Ph.D.       mhmaddux@cmh.edu   
Sub-Investigator: Michele Maddux, Ph.D.         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kevin Hommel, Ph.D.    513-803-0407    kevin.hommel@cchmc.org   
Contact: Katherine Loreaux, BA    513-803-1009    katherine.loreaux@cchmc.org   
Sub-Investigator: Lee Denson, M.D.         
Sub-Investigator: Richard Ittenbach, Ph.D.         
Principal Investigator: Kevin Hommel, Ph.D.         
University of Cincinnati Active, not recruiting
Cincinnati, Ohio, United States, 45221
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Wallace Crandall, M.D.       wallace.crandall@nationwidechildrens.org   
Sub-Investigator: Wallace Crandall, M.D.         
United States, Oklahoma
Oklahoma State University Active, not recruiting
Stillwater, Oklahoma, United States, 74074
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robert Baldassano, M.D.       baldassano@email.chop.edu   
Sub-Investigator: Robert Baldassano, M.D.         
Sponsors and Collaborators
Investigators
Principal Investigator: Kevin Hommel, Ph.D. Children's Hospital Medical Center, Cincinnati
Study Chair: Robert Baldassano, M.D. Children's Hospital of Philadelphia
Study Chair: Wallace Crandall, M.D. Nationwide Children's Hospital
Study Chair: Francisco Sylvester, M.D. Connecticut Children's Medical Center
Study Chair: Lee Denson, M.D. Children's Hospital Medical Center, Cincinnati
Study Chair: Michele Maddux, Ph.D. Children's Mercy Hospital Kansas City
Study Chair: Melvin Heyman, M.D. University of California San Francisco Benioff Children's Hospital
  More Information

No publications provided

Responsible Party: Kevin Hommel, Associate Professor of Pediatrics, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01536509     History of Changes
Other Study ID Numbers: R01 HD067174
Study First Received: February 16, 2012
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014