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

NCT01237847 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-11-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

2 Family-based problem solving phone sessions

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

BEHAVIORAL

4 Family-based problem solving phone intervention sessions

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

BEHAVIORAL

Wait list comparison group

Wait list comparison group to receive intervention at later point.

Sponsors & Collaborators

  • Medical College of Wisconsin

    collaborator OTHER
  • Children's Hospital and Health System Foundation, Wisconsin

    collaborator OTHER
  • Rosalind Franklin University of Medicine and Science

    lead OTHER

Principal Investigators

  • Rachel Neff Greenley, PhD · Rosalind Franklin University of Medicine and Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-12-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01237847 on ClinicalTrials.gov