Inflammatory Bowel Disease
Conditions
Keywords
inflammatory bowel disease, IBD, Crohn's disease, ulcerative colitis, adolescent
Brief summary
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.
Interventions
BEHAVIORAL2 Family-based problem solving phone sessions
2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
BEHAVIORAL4 Family-based problem solving phone intervention sessions
4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
BEHAVIORALWait list comparison group
Wait list comparison group to receive intervention at later point.
Sponsors
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Rosalind Franklin University of Medicine and Science
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* patient age 11-18 years * patient English speaking * patient legal guardian willing to participate * patient on oral IBD maintenance medication for 3 months or longer
Exclusion criteria
* history of significant parent-reported cognitive or developmental delay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | beginning at baseline - week 20 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life | at baseline, week 12, and week 20 |
| Adherence barriers | at baseline, week 12, and week 20 |
Countries
United States
Outcome results
None listed