Clinical trial NCT03138980: Mobile Self-Management of Irritable Bowel Syndrome for Adolescents
Official title: Mobile Self-Management of Irritable Bowel Syndrome for Adolescents: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Abdominal Pain
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: BodiMojo, Inc.
First posted: 2017-05-03
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the proposed research is to conduct user testing of a mobile-based self-management support intervention for adolescents and young adults with Irritable Bowel Syndrome (IBS), a chronic digestive condition. The application (app; BodiMojo Buddy) uses a virtual coach that can serve to increase patient engagement through interactive skill-building, self-care, and mindfulness-based cognitive behavioral activities. If the BodiMojo Buddy mobile app is successful, it will have a significant public health impact by providing a mobile resource to the 10-15% of the US population who suffer from IBS and potentially improving health outcomes and reducing significant costs to the US healthcare system.

Study participation involves participants downloading and using the app for 30 days. During the 30 days, participants will interact with the app by inputting their current mood, receiving supportive feedback from the app, reading messages, and doing brief activities (such as relaxation activities, etc.). Before and after the 30 days of user testing, participants will complete a few brief questionnaires about their behavior, how their symptoms affect their life, and how they receive support from others. These questions will take around 20 minutes to complete at each administration.


Eligibility criteria: Inclusion Criteria:

1. Age 13-21 years
2. For adolescents: Parent-reported physician diagnosis of IBS, using pediatric Rome III diagnostic criteria for functional gastrointestinal disorders. For young adults: self-reported physician diagnosis of IBS using Rome III diagnostic criteria, or meeting criteria for IBS or functional abdominal pain as determined during phone screening.
3. Have daily use of an iPhone or iPad that meets the following technical specifications: at least iOS 8; for iPhones, must be iPhone 5 or above.
4. Able and willing to give informed assent/consent and comply with study requirements
5. Have one caregiver willing and able to participate in the study \[only for 13-17 year olds\]

Exclusion Criteria:

1. Inability to provide informed assent/permission/consent
2. Inability to read, speak, and understand English (because the app content/parent guides are written in English, as are the measures being used in the study)

Primary outcomes:
measure: Ratio of the days during the 30-day intervention period during which participants use the app
timeFrame: 30 days (from day 1 through day 30 of the 30-day intervention period)
measure: Acceptance
timeFrame: Within 7 days of competing the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Pediatric Pain Program Research Offices
state: California
Study officials:
References: