RECRUITING

Evaluation of the SMART IBD App in Pediatric IBD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.

Official Title

Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease

Quick Facts

Study Start:2025-09-30
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07195123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)
  2. * Prescribed at least one daily or weekly medication for treatment of IBD
  3. * \<86% adherence to prescribed medication
  4. * Access to internet via Wi-Fi or data plan and access to smartphone
  5. * English fluency for patient and caregiver
  1. * Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
  2. * Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

Contacts and Locations

Study Contact

Kevin Hommel, PhD
CONTACT
513-803-0407
kevin.hommel@cchmc.org
Jessica King, BA
CONTACT
513-803-0920
jessica.king1@cchmc.org

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-30
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2025-09-30
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • IBD
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Indeterminate Colitis
  • Crohns Disease

Additional Relevant MeSH Terms

  • Inflammatory Bowel Disease (IBD)
  • IBD (Inflammatory Bowel Disease)
  • IBD - Inflammatory Bowel Disease
  • Ulcerative Colitis (UC)
  • Indeterminate Colitis
  • Crohn Disease (CD)