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

NCT01237847 | Unknown

• 1 other identifier: CCFA#2838
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

inflammatory bowel disease; IBD; Crohn's disease; ulcerative colitis; adolescent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Quality of Life

  at baseline, week 12, and week 20

• Adherence barriers

  at baseline, week 12, and week 20

Study Arms (3)

Wait List

OTHER

Behavioral: Wait list comparison group

2 phone sessions

EXPERIMENTAL

Behavioral: 2 Family-based problem solving phone sessions

4 phone sessions

EXPERIMENTAL

Behavioral: 4 Family-based problem solving phone intervention sessions

Interventions

2 Family-based problem solving phone sessions BEHAVIORAL

2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.

2 phone sessions

4 Family-based problem solving phone intervention sessions BEHAVIORAL

4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.

4 phone sessions

Wait list comparison group BEHAVIORAL

Wait list comparison group to receive intervention at later point.

Wait List

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• history of significant parent-reported cognitive or developmental delay

Sponsors & Collaborators

• Rosalind Franklin University of Medicine and Science: lead
• Medical College of Wisconsin: collaborator
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53213, United States

Location

Related Publications (2)

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

• Greenley RN, Gumidyala AP, Nguyen E, Plevinsky JM, Poulopoulos N, Thomason MM, Walter JG, Wojtowicz AA, Blank E, Gokhale R, Kirschner BS, Miranda A, Noe JD, Stephens MC, Werlin S, Kahn SA. Can You Teach a Teen New Tricks? Problem Solving Skills Training Improves Oral Medication Adherence in Pediatric Patients with Inflammatory Bowel Disease Participating in a Randomized Trial. Inflamm Bowel Dis. 2015 Nov;21(11):2649-57. doi: 10.1097/MIB.0000000000000530.

  PMID: 26218142 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Rachel Neff Greenley, PhD

  Rosalind Franklin University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: November 10, 2010

Record last verified: 2010-11

Locations

US (1)