Evaluation of the SMART IBD App in Pediatric IBD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)

Prescribed at least one daily or weekly medication for treatment of IBD

<86% adherence to prescribed medication

Access to internet via Wi-Fi or data plan and access to smartphone

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SMART-IBD

    Behavioral

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: SMART-IBD AppExperimental treatment 1 intervention
Group B: Attention ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Medication adherence

Medication adherence will be measured by daily responses by participants to prompts in the SMART IBD app regarding whether each dose was taken for each medication. A mean adherence score will be calculated across medications for each participant for the 28 day periods at baseline and post-treatment.

Time frame
6 months

Secondary outcomes

1

Disease Activity

PROs will be collected regarding composite disease activity comprised of fecal calprotectin, stool frequency, and rectal bleeding for ulcerative colitis and fecal calprotectin, stool frequency, and abdominal pain for Crohn's. Stool samples collected at baseline and post-assessment will also be utilized to assess diseases activity.

Time frame
6 months
2

Sleep Duration

Sleep duration will be assessed via the SMART IBD App diary on a scale of 0-18 hours or more with half hour increments. Participants in both arms will report sleep duration via the diary.

Time frame
6 months
3

Stress

Stress will be assessed via the SMART IBD App diary on a scale of 0-10, where 0 is no stress and 10 is highest stress. Participants in both arms will report stress via the diary.

Time frame
6 months

Other outcomes

Sponsors and contacts

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