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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
Rosalind Franklin University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

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

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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
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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

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