A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease (PHONE)
Primary Purpose
Inflammatory Bowel Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2 Family-based problem solving phone sessions
4 Family-based problem solving phone intervention sessions
Wait list comparison group
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring inflammatory bowel disease, IBD, Crohn's disease, ulcerative colitis, adolescent
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
Sites / Locations
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Wait List
2 phone sessions
4 phone sessions
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of Life
Adherence barriers
Full Information
NCT ID
NCT01237847
First Posted
November 9, 2010
Last Updated
November 9, 2010
Sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
Medical College of Wisconsin, Children's Hospital and Health System Foundation, Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT01237847
Brief Title
A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
Acronym
PHONE
Official Title
A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
Medical College of Wisconsin, Children's Hospital and Health System Foundation, Wisconsin
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
inflammatory bowel disease, IBD, Crohn's disease, ulcerative colitis, adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wait List
Arm Type
Other
Arm Title
2 phone sessions
Arm Type
Experimental
Arm Title
4 phone sessions
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
2 Family-based problem solving phone sessions
Intervention Description
2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
Intervention Type
Behavioral
Intervention Name(s)
4 Family-based problem solving phone intervention sessions
Intervention Description
4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
Intervention Type
Behavioral
Intervention Name(s)
Wait list comparison group
Intervention Description
Wait list comparison group to receive intervention at later point.
Primary Outcome Measure Information:
Title
Adherence
Description
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.
Time Frame
beginning at baseline - week 20
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
at baseline, week 12, and week 20
Title
Adherence barriers
Time Frame
at baseline, week 12, and week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Neff Greenley, PhD
Organizational Affiliation
Rosalind Franklin University of Medicine and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26218142
Citation
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. Erratum In: Inflamm Bowel Dis. 2015 Nov;21(11):2657.
Results Reference
derived
Learn more about this trial
A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
We'll reach out to this number within 24 hrs