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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
| Children's Hospital and Health System Foundation, Wisconsin | OTHER |
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This project will test if a phone intervention can improve the medicine-taking behavior of teens with IBD. The investigators will study teens who are taking medicine by mouth. The investigators will test if two phone calls that help teens solve problems with their IBD medicine help to increase how often teens take their medicine. The study will also see if there is any extra benefit of more sessions (four compared to two). The investigators will ask 90 teens to be in the study. Teens can be in the study if they are 11-18 years old and speak English. They must also take an IBD medication by mouth and have a parent who also wants to be in the study. Teens who agree to be in the study will fill out forms at the beginning (participant week 0), middle (participant week 12), and end of the study (participant week 20). After assessment 1, they will be randomly assigned to either receive 2 phone calls or a wait list group (participant weeks 6-10). After that, they will complete a second assessment. After the second assessment, teens who got the 2 phone calls right will be re-randomized to two more sessions or no more sessions (participant weeks 14-18). Teens who were in the wait list group will get two phone sessions (participant weeks 14-18). After that, there will be a final assessment (participant week 20). The investigators expect the phone intervention sessions to reduce barriers to medicine taking, improve medicine taking, and improve teen quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wait List | Other |
| |
| 2 phone sessions | Experimental |
| |
| 4 phone sessions | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 Family-based problem solving phone sessions | Behavioral | 2 family-based problem solving phone sessions to address and ameliorate barriers to adherence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | participants will use MEMS bottles to capture adherence data from participant week 0 - participant week 20. Additionally, adherence interviews and pill counts will be conducted at participant week 0, 12, and 20. | beginning at baseline - week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | at baseline, week 12, and week 20 | |
| Adherence barriers | at baseline, week 12, and week 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Neff Greenley, PhD | Rosalind Franklin University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53213 | 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. | |
| 26218142 | Derived | Greenley RN, Gumidyala AP, Nguyen E, Plevinsky JM, Poulopoulos N, Thomason MM, Walter JG, Wojtowicz AA, Blank E, Gokhale R, Kirschner BS, Miranda A, Noe JD, Stephens MC, Werlin S, Kahn SA. Can You Teach a Teen New Tricks? Problem Solving Skills Training Improves Oral Medication Adherence in Pediatric Patients with Inflammatory Bowel Disease Participating in a Randomized Trial. Inflamm Bowel Dis. 2015 Nov;21(11):2649-57. doi: 10.1097/MIB.0000000000000530. |
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| 4 Family-based problem solving phone intervention sessions | Behavioral | 4 family-based problem solving phone sessions to address and ameliorate barriers to adherence. |
|
| Wait list comparison group | Behavioral | Wait list comparison group to receive intervention at later point. |
|
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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