Overview

This trial is active, not recruiting.

Condition inflammatory bowel disease
Treatments 2 family-based problem solving phone sessions, 4 family-based problem solving phone intervention sessions, wait list comparison group
Sponsor Rosalind Franklin University of Medicine and Science
Collaborator Medical College of Wisconsin
Start date July 2010
End date December 2012
Trial size 90 participants
Trial identifier NCT01237847, CCFA#2838

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
wait list comparison group
Wait list comparison group to receive intervention at later point.
(Experimental)
2 family-based problem solving phone sessions
2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
(Experimental)
4 family-based problem solving phone intervention sessions
4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.

Primary Outcomes

Measure
Adherence
time frame: beginning at baseline - week 20

Secondary Outcomes

Measure
Quality of Life
time frame: at baseline, week 12, and week 20
Adherence barriers
time frame: at baseline, week 12, and week 20

Eligibility Criteria

Male or female participants from 11 years up to 18 years old.

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

Additional Information

Official title A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
Principal investigator Rachel Neff Greenley, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Rosalind Franklin University of Medicine and Science.