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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Behavioral Treatment | Experimental |
| |
| Education Only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Behavioral Treatment (TBT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | Medication adherence will be measured using electronic monitoring. The specific device is the MEMS TrackCap. Immunomodulators and/or mesalamine medications will be assessed. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | The IMPACT III measure will be used for this assessment. This is an IBD-specific HRQOL assessment tool. | 15 months |
| Disease Severity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Hommel, Ph.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| 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. | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco Benioff Children's Hospital | San Francisco | California | 94143 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | 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. |
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| Education Only (EO) | Behavioral | 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. |
|
| 15 months |
| Health care utilization | 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. | 15 months |
| Connecticut Children's Medical Center |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45221 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Oklahoma State University | Stillwater | Oklahoma | 74074 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Childrens Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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