Improving Medication Adherence in Pediatric Inflammatory Bowel Disease (TEAM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01536509|
Recruitment Status : Active, not recruiting
First Posted : February 22, 2012
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||July 2017|
|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.
- Medication adherence [ Time Frame: 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.
- Health-related quality of life [ Time Frame: 15 months ]The IMPACT III measure will be used for this assessment. This is an IBD-specific HRQOL assessment tool.
- Disease Severity [ Time Frame: 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.
- Health care utilization [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536509
|United States, California|
|University of California San Francisco Benioff Children's Hospital|
|San Francisco, California, United States, 94143|
|United States, Connecticut|
|Connecticut Children's Medical Center|
|Hartford, Connecticut, United States, 06106|
|United States, Missouri|
|Children's Mercy Hospitals and Clinics|
|Kansas City, Missouri, United States, 64108|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45221|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Oklahoma|
|Oklahoma State University|
|Stillwater, Oklahoma, United States, 74074|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Childrens Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|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|
|Study Chair:||David Keljo, M.D.||Children's Hospital of Pittsburgh of UPMC|