Improving Medication Adherence in Pediatric Inflammatory Bowel Disease

Description

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.

Study Start Date

February 2012

Estimated Completion Date

July 2017

Interventions

  • Behavioral: Telehealth Behavioral Treatment (TBT)
  • Behavioral: Education Only (EO)

Specialties

  • Pediatrics: Peds Gastroenterology
  • Gastroenterology: Inflammatory Bowel Dz,Peds Gastroenterology

MeSH Terms

  • Colitis
  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Intestinal Diseases

Study ID

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) -- R01 HD067174

Status

Unknown

Trial ID

NCT01536509

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

194

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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, or Nationwide Children's Hospital
  • 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 an oral immunomodulator (e.g., 6-MP/azathioprine) and/or 5-ASA (e.g., mesalamine)
  • 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

Gender

Both

Ages

11 Years to 18 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
Connecticut Childrens Medical Center - Hartford, Connecticut 92.3 miles None None None
Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Robert Baldassano MD None baldassano@email.chop.edu
Childrens Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania 477.6 miles David J Keljo MD 412-692-5180 keljodj@upmc.edu
Nationwide Childrens Hospital - Columbus, Ohio 640.0 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles Kevin Hommel PhD 513-803-0407 kevin.hommel@cchmc.org
University of Cincinnati - Cincinnati, Ohio 737.7 miles None None None
Childrens Mercy Hospitals and Clinics - Kansas City, Missouri 1,249.3 miles Michele Maddux PhD None mhmaddux@cmh.edu
Oklahoma State University - Stillwater, Oklahoma 1,452.8 miles None None None
University of California San Francisco Benioff Childrens Hospital - San Francisco, California 2,699.8 miles Melvin Heyman MD None mheyman@peds.ucsf.edu

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