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

Inflammatory Bowel Disease Clinical Trial

— PHONE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01237847
• Other study ID #: CCFA#2838
• Status: Active, not recruiting
• Phase: N/A
• First received: November 9, 2010
• Last updated: November 9, 2010
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: November 2010
• Source: Rosalind Franklin University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Behavioral:
• 2 Family-based problem solving phone sessions
2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
• 4 Family-based problem solving phone intervention sessions
4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
• Wait list comparison group
Wait list comparison group to receive intervention at later point.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science	Children's Hospital and Health System Foundation, Wisconsin, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	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.	beginning at baseline - week 20	No
Secondary	Quality of Life		at baseline, week 12, and week 20	No
Secondary	Adherence barriers		at baseline, week 12, and week 20	No