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Peer Mentoring for Inflammatory Bowel Disease

N/A

Recruiting

Research Sponsored by Laura Mackner

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mentees must have a diagnosis of IBD

Mentees must be between the ages of 10 and 17 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months post mentor-mentee introduction

Awards & highlights

Study Summary

This trial is testing whether a peer mentoring program can help improve the self-management of youth with IBD.

Who is the study for?

This trial is for youth aged 10-17 with IBD and their parents, fluent in English, without neurodevelopmental or psychiatric hospitalization history. Mentors must be over 16, managing IBD well for at least a year post-diagnosis, and pass rigorous screening.Check my eligibility

What is being tested?

The study tests a peer mentoring program's effectiveness on improving self-management in youths with IBD. It includes mentor-mentee activities, educational content, parent support groups versus an education-only comparison group.See study design

What are the potential side effects?

There are no medical side effects as this is not a drug trial; however participants may experience emotional or psychological impacts from the social interactions and discussions about their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with inflammatory bowel disease (IBD).

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I am between 10 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months post mentor-mentee introduction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months post mentor-mentee introduction

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months post mentor-mentee introduction for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

12 month change from baseline Youth quality of life: PedsQL

12 month change from baseline youth functional disability

12 month youth functional disability

+5 more

Secondary outcome measures

12 month Parent QOL

Crohn Disease

12 month Youth disease outcomes - Ulcerative Colitis severity

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mentoring programExperimental Treatment6 Interventions

The Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month. Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event. Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing. Parents join the mentees and mentors for the educational topics. Due to the COVID-19 pandemic, these activities can be conducted virtually.

Group II: Educational activity programActive Control3 Interventions

The Educational Activity comparison group consists of separate educational group events on the same topics (with no social time), educational information posted online, and monthly encouragement to engage in activities in the community. Due to the COVID-19 pandemic, participants are encouraged to interact socially in safe ways, e.g., outdoors or virtually.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mentor

2014

N/A

~3510

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rosalind Franklin University of Medicine and ScienceOTHER

13 Previous Clinical Trials

607 Total Patients Enrolled

Laura MacknerLead Sponsor

Children's Hospital Medical Center, CincinnatiOTHER

815 Previous Clinical Trials

6,531,297 Total Patients Enrolled

Media Library

Peer Mentoring Clinical Trial Eligibility Overview. Trial Name: NCT03827109 — N/A

Crohn's Disease Research Study Groups: Mentoring program, Educational activity program

Crohn's Disease Clinical Trial 2023: Peer Mentoring Highlights & Side Effects. Trial Name: NCT03827109 — N/A

Peer Mentoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT03827109 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ambition behind this investigation?

"Over a period spanning from Baseline to 18 months post mentor-mentee introduction, the primary outcome of this clinical trial will be measured in terms of 12 month change from baseline youth functional disability. The secondary indicators include 12 month number of procedures appointments over 6 months prior, 12 month Mentor QOL as scored on PedsQL Adult Report (full scale name), and finally 18 month Youth disease outcomes - Crohn's disease severity with results provided by Pediatric Crohn's Disease Activity Index total score where higher scores signify more serious conditions."

Answered by AI

What eligibility requirements must be met in order to participate in this experiment?

"Eligible candidates for this medical study must have inflammatory bowel diseases and be between 10-17 years old. The team is aiming to recruit around 300 participants."

Answered by AI

Does this research encompass individuals over 40 years of age?

"The age range for participants in this trial is between 10 and 17 years old."

Answered by AI

Are there presently any opportunities for individuals to participate in this experiment?

"Data available on clinicaltrials.gov confirms that this medical experiment is making efforts to recruit participants. Initially published on June 12th 2019, the trial's information was recently amended on September 26th 2022."

Answered by AI

How many participants are participating in this clinical experiment?

"Affirmative. Per the details available on clinicaltrials.gov, this medical trial is currently recruiting patients and has been doing so since June 12th 2019. 300 participants are being sought from one location, with updates to the listing having taken place as recently as September 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Peer Mentoring to Improve Self-management in Youth With IBD

Laura Mackner 2019. "Peer Mentoring to Improve Self-management in Youth With IBD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03827109.

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