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Clinical Trials/NCT01237847
NCT01237847
Unknown
Not Applicable

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

Rosalind Franklin University of Medicine and Science1 site in 1 country90 target enrollmentJuly 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Disease
Sponsor
Rosalind Franklin University of Medicine and Science
Enrollment
90
Locations
1
Primary Endpoint
Adherence
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 2013
Last Updated
15 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Adherence

Time Frame: 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 Outcomes

  • Quality of Life(at baseline, week 12, and week 20)
  • Adherence barriers(at baseline, week 12, and week 20)

Study Sites (1)

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