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4 phone sessions for Inflammatory Bowel Disease (PHONE Trial)

N/A
Waitlist Available
Led By Rachel Neff Greenley, PhD
Research Sponsored by Rosalind Franklin University of Medicine and Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week 12, and week 20
Awards & highlights

PHONE Trial 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.

Eligible Conditions
  • Inflammatory Bowel Disease

PHONE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, week 12, and week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 12, and week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence
Secondary outcome measures
Adherence barriers
Quality of Life

PHONE Trial Design

3Treatment groups
Experimental Treatment
Group I: Wait ListExperimental Treatment1 Intervention
Group II: 4 phone sessionsExperimental Treatment1 Intervention
Group III: 2 phone sessionsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Rosalind Franklin University of Medicine and ScienceLead Sponsor
13 Previous Clinical Trials
817 Total Patients Enrolled
Medical College of WisconsinOTHER
609 Previous Clinical Trials
1,162,511 Total Patients Enrolled
Children's Hospital and Health System Foundation, WisconsinOTHER
55 Previous Clinical Trials
96,559 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Apr 2025