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

Not Applicable

• Conditions: Inflammatory Bowel Disease
• Interventions: Behavioral: Wait list comparison group; Behavioral: 2 Family-based problem solving phone sessions; Behavioral: 4 Family-based problem solving phone intervention sessions

• Registration Number: NCT01237847
• Lead Sponsor: Rosalind Franklin University of Medicine and Science

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-11
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Last Update Submitted: 2010-11-09
• Study First Posted: 2010-11-10
• Last Update Posted: 2010-11-10
• Primary Completion: 2012-12
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Wait List	Wait list comparison group	-
2 phone sessions	2 Family-based problem solving phone sessions	-
4 phone sessions	4 Family-based problem solving phone intervention sessions	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Life	at baseline, week 12, and week 20
Adherence barriers	at baseline, week 12, and week 20

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States