SMART-IBD App Trial

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT06023667
Collaborator
(none)
30
1
2
12.6
2.4

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
  • 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.

Outcome Measures

Primary Outcome Measures

  1. 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:
No
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:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Children's Hospital Medical Center, Cincinnati
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2023