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MyIBD Tool for Pediatric IBD

N/A

Recruiting

Led By Neal deJong, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Age 13-19 years old at time of recruitment

Be younger than 65 years old

Must not have

Speaker of a language other than English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up reported at the end of study year 2

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new communication tool called MyIBD in teenagers with inflammatory bowel disease. The main questions it wants to answer are whether MyIBD is easy to use in everyday clinical practice

Who is the study for?

This trial is for young people aged 13 to 19 who have inflammatory bowel disease. To join, they must be willing to use the MyIBD communication tool and complete several surveys about their care over a year. Specific details on what conditions would exclude someone from participating are not provided.

What is being tested?

The study is testing a new tool called MyIBD designed to help teenagers with IBD manage their condition better. It will compare the experiences of those using MyIBD against those receiving standard care by assessing self-management skills and quality of care through surveys at different intervals.

What are the potential side effects?

Since this trial involves a communication tool rather than medication, traditional physical side effects are not expected. However, there may be psychological or emotional impacts related to managing one's health condition that could arise from participation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 13 and 19 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I speak a language other than English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ reported at the end of study year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~reported at the end of study year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and reported at the end of study year 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of control group participants who receive a MyIBD document

Number of intervention group participants who agree or completely agree that MyIBD is an acceptable intervention using the Acceptability of Intervention Measure

Number of intervention group participants who agree or completely agree that MyIBD is an appropriate intervention using the Intervention Appropriateness Measure

+5 more

Secondary study objectives

Mean perceived Quality of Care score at 12 months using the Patient Assessment of Chronic Illness Care survey

Mean perceived Quality of Care score at baseline using the Patient Assessment of Chronic Illness Care survey

Mean self-management score on the Partners in Health scale at 12 months

+2 more

Other study objectives

Average number of non-injury-related visits to an emergency department (ED) in the past year, 12 months

Average number of non-injury-related visits to an emergency department (ED) in the past year, baseline

Number of overall participants who completed a primary care health supervision visit in the past year, 12 months

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MyIBDExperimental Treatment1 Intervention

Each participant randomized to the intervention arm (MyIBD) will receive an individually tailored MyIBD document within a week of a scheduled outpatient clinic visit. The MyIBD document will be prepared by the patient's usual, assigned nurse coordinator together with the study's clinical champion (a nurse practitioner in the IBD program). Participants will receive a copy of the MyIBD document with language suggesting that they use it to guide decisions about care in between appointments. Each participant's primary care provider will also receive a copy of the MyIBD document. The nurse coordinator will send reminder messages to intervention-group participants (using the electronic patient portal) to access and use their MyIBD document at 1-2 months, 3-4 months, 7-8 months, and 11-12 months after initial plan creation.

Group II: Usual CareActive Control1 Intervention

Each participant randomized to the control group will receive usual care in the pediatric IBD program. They will be eligible to receive a MyIBD document after completing the study (12 months after enrollment).

0 / 2Eligibility criteria met