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

Rosalind Franklin University of Medicine and Science logo

Rosalind Franklin University of Medicine and Science

Status

Unknown

Conditions

Inflammatory Bowel Disease

Treatments

Behavioral: Wait list comparison group
Behavioral: 2 Family-based problem solving phone sessions
Behavioral: 4 Family-based problem solving phone intervention sessions

Study type

Interventional

Funder types

Other

Identifiers

NCT01237847
CCFA#2838

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

11 to 18 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

90 participants in 3 patient groups

Wait List
Other group
Treatment:
Behavioral: Wait list comparison group
2 phone sessions
Experimental group
Treatment:
Behavioral: 2 Family-based problem solving phone sessions
4 phone sessions
Experimental group
Treatment:
Behavioral: 4 Family-based problem solving phone intervention sessions

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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