Clinical trial NCT01237847: A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
Official title: A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: inflammatory bowel disease
IBD
Crohn's disease
ulcerative colitis
adolescent
Lead sponsor: Rosalind Franklin University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2010-11-10
Enrollment: 90
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: beginning at baseline - week 20
Secondary outcomes:
measure: Quality of Life
timeFrame: at baseline, week 12, and week 20
measure: Adherence barriers
timeFrame: at baseline, week 12, and week 20
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Rosalind Franklin University of Medicine and Science
name: Rachel Neff Greenley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.