Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01237847
Recruitment Status : Unknown
Verified November 2010 by Rosalind Franklin University of Medicine and Science.
Recruitment status was:  Active, not recruiting
First Posted : November 10, 2010
Last Update Posted : November 10, 2010
Sponsor:
Collaborators:
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Information provided by:
Rosalind Franklin University of Medicine and Science

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Behavioral: 2 Family-based problem solving phone sessions Behavioral: 4 Family-based problem solving phone intervention sessions Behavioral: Wait list comparison group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Brief Intervention to Improve Adherence in Teens With Inflammatory Bowel Disease
Study Start Date : July 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : July 2013

Arm Intervention/treatment
Wait List Behavioral: Wait list comparison group
Wait list comparison group to receive intervention at later point.

Experimental: 2 phone sessions Behavioral: 2 Family-based problem solving phone sessions
2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.

Experimental: 4 phone sessions Behavioral: 4 Family-based problem solving phone intervention sessions
4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: at baseline, week 12, and week 20 ]
  2. Adherence barriers [ Time Frame: at baseline, week 12, and week 20 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237847


Locations
Layout table for location information
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53213
Sponsors and Collaborators
Rosalind Franklin University of Medicine and Science
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Layout table for investigator information
Principal Investigator: Rachel Neff Greenley, PhD Rosalind Franklin University of Medicine and Science
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rachel Neff Greenley PhD, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier: NCT01237847    
Other Study ID Numbers: CCFA#2838
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: November 2010
Keywords provided by Rosalind Franklin University of Medicine and Science:
inflammatory bowel disease
IBD
Crohn's disease
ulcerative colitis
adolescent
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis