Back to resultsSMART-IBD App Trial
Primary Purpose
Inflammatory Bowel Diseases, IBD, Crohn Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART-IBD
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring IBD
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SMART-IBD
Attention Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Medication adherence
Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app
Secondary Outcome Measures
Full Information
NCT ID
NCT06023667
First Posted
July 28, 2023
Last Updated
September 1, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT06023667
Brief Title
SMART-IBD App Trial
Official Title
Self-Management Assistance for Recommended Treatement (SMART) App Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, IBD, Crohn Disease, Ulcerative Colitis
Keywords
IBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMART-IBD
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMART-IBD
Intervention Description
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Primary Outcome Measure Information:
Title
Medication adherence
Description
Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Hommel, PhD
Phone
513-803-0407
Email
kevin.hommel@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica King, BA
Phone
513-803-0920
Email
jessica.king1@cchmc.org
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Hommel, PhD
Phone
513-803-0407
Email
kevin.hommel@cchmc.org
First Name & Middle Initial & Last Name & Degree
Jessica King, BA
Phone
513-803-0920
Email
jessica.king1@cchmc.org
12. IPD Sharing Statement
Learn more about this trial
SMART-IBD App Trial
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