SMART-IBD App Trial

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Recruiting

CT.gov ID

NCT06023667

Collaborator

(none)

Enrollment

Location

Arms

12.6

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 a sample of 15 youth (ages 13-17) with IBD using an app that has educational content and medication reminders to 15 youth in an attention control group. The length of the intervention will include one month of baseline adherence data collection, one month of intervention, and one month of post-treatment adherence data collection.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases IBD Crohn Disease Ulcerative Colitis	Behavioral: SMART-IBD	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments will be blinded. Only study coordinators will have access to the assignment of each participant.

Primary Purpose:

Treatment

Official Title:

Self-Management Assistance for Recommended Treatement (SMART) App Randomized Control Trial

Actual Study Start Date :

Dec 14, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SMART-IBD The SMART-IBD app consists of educational content, medication reminders, and weekly app engagement challenges. App users will participate in weekly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention, and one month of diaries post-intervention.	Behavioral: SMART-IBD Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
No Intervention: Attention Control Participants in this arm will not receive any intervention content. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention and one month of diaries post-intervention.

Arm

Intervention/Treatment

Experimental: SMART-IBD

The SMART-IBD app consists of educational content, medication reminders, and weekly app engagement challenges. App users will participate in weekly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention, and one month of diaries post-intervention.

Behavioral: SMART-IBD

Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.

No Intervention: Attention Control

Participants in this arm will not receive any intervention content. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention and one month of diaries post-intervention.

Outcome Measures

Primary Outcome Measures

Medication adherence [3 months]
Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively IBD)
Prescribed at least one medication used to treat IBD, regardless of route of administration
Access to internet or wi-fi or data plan and access to smartphone
English fluency for patient and clinician

Exclusion Criteria:

Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT06023667

Other Study ID Numbers:

SMART-IBD

First Posted:

Sep 5, 2023

Last Update Posted:

Sep 5, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Children's Hospital Medical Center, Cincinnati

IBD

Additional relevant MeSH terms:

Crohn Disease

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Sep 5, 2023