- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237847
A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease (PHONE)
November 9, 2010 updated by: Rosalind Franklin University of Medicine and Science
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wisconsin
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Milwaukee, Wisconsin, United States, 53213
- Children's Hospital of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Wait List
|
Wait list comparison group to receive intervention at later point.
|
Experimental: 2 phone sessions
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2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
|
Experimental: 4 phone sessions
|
4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
beginning at baseline - week 20
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: at baseline, week 12, and week 20
|
at baseline, week 12, and week 20
|
Adherence barriers
Time Frame: at baseline, week 12, and week 20
|
at baseline, week 12, and week 20
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rachel Neff Greenley, PhD, Rosalind Franklin University of Medicine and Science
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
November 9, 2010
First Submitted That Met QC Criteria
November 9, 2010
First Posted (Estimate)
November 10, 2010
Study Record Updates
Last Update Posted (Estimate)
November 10, 2010
Last Update Submitted That Met QC Criteria
November 9, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCFA#2838
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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