Mentor for Inflammatory Bowel Diseases

Phase-Based Estimates
1
Effectiveness
1
Safety
Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH
Inflammatory Bowel Diseases+4 More
Mentor - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Inflammatory Bowel Diseases

Study Summary

Peer Mentoring to Improve Self-management in Youth With IBD

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Eligible Conditions

  • Inflammatory Bowel Diseases
  • Colitis, Ulcerative
  • Ileocolitis
  • Pediatric Crohn’s Disease
  • Crohn Disease
  • Ulcerative Colitis, Pediatric

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Mentor will improve 8 primary outcomes and 17 secondary outcomes in patients with Inflammatory Bowel Diseases. Measurement will happen over the course of Baseline to 12 months post mentor-mentee introduction.

Month 12
12 month Parent QOL
12 month Youth disease outcomes - Crohn's Disease severity
12 month Youth disease outcomes - Ulcerative Colitis severity
12 month number of clinic appointments in previous 6 months
12 month number of hospital admissions in previous 6 months
12 month number of missed appointments in previous 6 months
12 month number of procedures in previous 6 months
12 month youth functional disability
12 month youth quality of life: PedsQL
12 months Mentor QOL
Month 18
18 month Youth disease outcomes - Crohn's Disease severity
18 month Youth disease outcomes - Ulcerative Colitis severity
18 month number of clinic appointments in previous 6 months
18 month number of hospital admissions in previous 6 months
18 month number of missed appointments in previous 6 months
18 month number of procedures in previous 6 months
18 month youth functional disability
18 month youth quality of life: PedsQL
18 months Mentor QOL
Month 12
12 month change from baseline Mentor QOL
12 month change from baseline Parent QOL
12 month change from baseline Youth quality of life: PedsQL
12 month change from baseline youth functional disability
Month 18
18 month change from baseline Youth quality of life: PedsQL
18 month change from baseline youth functional disability

Trial Safety

Trial Design

2 Treatment Groups

Educational activity program
Mentoring program

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mentor is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Mentoring programThe 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.
Educational activity programThe 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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months post mentor-mentee introduction
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18 months post mentor-mentee introduction for reporting.

Closest Location

Abigail Wexner Research Institute at Nationwide Children's Hospital - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Managing their IBD well
Pass a screening that includes an online application, interview, 3 character references, checks of driving records and social media, background check, mentor training
Diagnosis of IBD
Age 10 - 17 years
Parent and child English fluency
No documented neuro-developmental disorder or history of hospitalization for a psychiatric or behavioral disorder
≥16 years
≥1 year post-diagnosis of IBD

Patient Q&A Section

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

What are the signs of inflammatory bowel diseases?

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This survey identified many signs associated with IBD, including bleeding, abdominal pain, diarrhea, fatigue and weight loss. These signs should be used by people that are trying to help

Unverified Answer

What are common treatments for inflammatory bowel diseases?

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There is no uniformity in treatments for IBDs, with some focusing on symptom control while others focus on the underlying cause. Treatment options can be broadly divided into nonsurgical, surgical and biological.

Unverified Answer

What causes inflammatory bowel diseases?

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Even though the exact underlying mechanism remains unclear, there are well-accepted theories based on the interplay between genetics and environment, and it is believed that this may contribute to the development of these diseases.

Unverified Answer

How many people get inflammatory bowel diseases a year in the United States?

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Around 7 million people of all ages are diagnosed with IBD a year in the United States, making it the third most common cause of morbidity and mortality. Among women, the age and female sex were risk factors for developing IBD.

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What is inflammatory bowel diseases?

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Inflammatory bowel diseases are a group of chronic diseases that primarily affect the small bowel of the gastrointestinal tract. Symptoms can range in severity and duration from daily to episodic to chronic and the underlying mechanism is often multifactorial. Clinical presentation can be chronic, with symptoms continuing for years or relapses may occur. New and less common features have been described.

Unverified Answer

Can inflammatory bowel diseases be cured?

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No evidence was found to support the idea that IBD can be cured. Further studies on the role of IBD in the pathogenesis of IBD are needed to further the science of IBD research towards cure.

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What is the latest research for inflammatory bowel diseases?

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Many ongoing or recently completed trials address therapies for Crohn's disease that are being actively explored. This area of research is dominated by clinical studies and has more high-quality studies than the rest of the IBD drug areas. Clinicians will probably be most interested in the upcoming studies on anti-TNF monoclonal antibodies, anti-IgE-neutralizing conjugates, and anti-TNF alpha antagonists.

Unverified Answer

How serious can inflammatory bowel diseases be?

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In the United States, inflammatory bowel disease has a major economic impact, in terms of hospitalizations, indirect health care expenditures, lost workdays, and decreased personal productivity. Patients' quality of life is also affected. It is critical that doctors recognize the seriousness of the disease and of the need for early diagnosis and treatment to avoid long-term consequences.

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Have there been other clinical trials involving mentor?

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Menthasone has been used as a monotherapy and as a steroid sparing agent in clinical trials for various conditions, and most clinical trials have been funded by the manufacturer.

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Is mentor safe for people?

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Mentors play a critical role in empowering medical students. Mentoring during a clinical clerkship by a respected professional in the patient’s own area of practice leads to improved and more effective clinical education for medical students.

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What does mentor usually treat?

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There were several common clinical scenarios where mentors were likely to prescribe a treatment. In a recent study, findings showed us that there may be considerable heterogeneity in what patients were being treated. More studies are needed to look at the heterogeneity among patients in their clinical scenarios.

Unverified Answer

Does inflammatory bowel diseases run in families?

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Families with either a family history of IBD with or without IBD-related symptoms may have a higher than expected prevalence of IBD. The increased frequency of the IBD-associated EDA and FH genes in the first-degree relatives of affected siblings is consistent with a common genetic aetiology.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Inflammatory Bowel Diseases by sharing your contact details with the study coordinator.