A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease (PHONE)

Rosalind Franklin University of Medicine and Science

Status: Unknown

Conditions: Inflammatory Bowel Disease

Treatments: Behavioral: Wait list comparison group; Behavioral: 2 Family-based problem solving phone sessions; Behavioral: 4 Family-based problem solving phone intervention sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT01237847

CCFA#2838

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Wait List

Other group

Treatment:

Behavioral: Wait list comparison group

2 phone sessions

Experimental group

Treatment:

Behavioral: 2 Family-based problem solving phone sessions

4 phone sessions

Experimental group

Treatment:

Behavioral: 4 Family-based problem solving phone intervention sessions