Improving Medication Adherence in Pediatric Inflammatory Bowel Disease
NCT ID: NCT01536509
Last Updated: 2020-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2012-02-29
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Telehealth Behavioral Treatment
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.
Education Only
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 serious mental illness (e.g., schizophrenia) in patient or parent
11 Years
18 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Kevin Hommel, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Robert Baldassano, M.D.
Role: STUDY_CHAIR
Children's Hospital of Philadelphia
Wallace Crandall, M.D.
Role: STUDY_CHAIR
Nationwide Children's Hospital
Francisco Sylvester, M.D.
Role: STUDY_CHAIR
Connecticut Children's Medical Center
Lee Denson, M.D.
Role: STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Michele Maddux, Ph.D.
Role: STUDY_CHAIR
Children's Mercy Hospital Kansas City
Melvin Heyman, M.D.
Role: STUDY_CHAIR
University of California San Francisco Benioff Children's Hospital
David Keljo, M.D.
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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University of California San Francisco Benioff Children's Hospital
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma State University
Stillwater, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Childrens Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Countries
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References
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Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
Other Identifiers
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