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Mobile Self-Management of Irritable Bowel Syndrome for Adolescents

Primary Purpose

Irritable Bowel Syndrome, Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BodiMojo Buddy for IBS
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA Pediatric Pain Program Research Offices

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile application

Arm Description

Outcomes

Primary Outcome Measures

Ratio of the days during the 30-day intervention period during which participants use the app
Determined by how often adolescents engaged and used certain features. To be considered feasible, teens must have opened the app on at least two-thirds of the days.
Acceptance
Determined by participants' responses to acceptance test questions in the following domains: (1) perceived connectedness with the Buddy; (2) relevance of the self-management skill building content; and (3) usefulness of self-management skill-building content for IBS. Responses will be given on a one to seven-point-scale ranging "terrible" to "excellent." The intervention will be deemed acceptable if at least 80% of participants rate each question an average of at least "5" ("good") on the 7-point scale.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2017
Last Updated
June 26, 2017
Sponsor
University of California, Los Angeles
Collaborators
BodiMojo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03138980
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 30, 2016 (Actual)
Primary Completion Date
September 22, 2016 (Actual)
Study Completion Date
September 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
BodiMojo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Abdominal Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile application
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
BodiMojo Buddy for IBS
Intervention Description
Mobile application focusing on emotional coping skills for teens and young adults with IBS. Components of the module include: mood recorder and "mood cloud," with supportive feedback given based on mood choice; health behavior change support messages informed by mindfulness and self-compassion; quizzes with tailored feedback; library of meditations; an interactive coping skills advice section; and a link to an optional social support feature.
Primary Outcome Measure Information:
Title
Ratio of the days during the 30-day intervention period during which participants use the app
Description
Determined by how often adolescents engaged and used certain features. To be considered feasible, teens must have opened the app on at least two-thirds of the days.
Time Frame
30 days (from day 1 through day 30 of the 30-day intervention period)
Title
Acceptance
Description
Determined by participants' responses to acceptance test questions in the following domains: (1) perceived connectedness with the Buddy; (2) relevance of the self-management skill building content; and (3) usefulness of self-management skill-building content for IBS. Responses will be given on a one to seven-point-scale ranging "terrible" to "excellent." The intervention will be deemed acceptable if at least 80% of participants rate each question an average of at least "5" ("good") on the 7-point scale.
Time Frame
Within 7 days of competing the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 13-21 years 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. 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. Able and willing to give informed assent/consent and comply with study requirements Have one caregiver willing and able to participate in the study [only for 13-17 year olds] Exclusion Criteria: Inability to provide informed assent/permission/consent 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)
Facility Information:
Facility Name
UCLA Pediatric Pain Program Research Offices
City
Los Angeles
State/Province
California
ZIP/Postal Code
90064
Country
United States

12. IPD Sharing Statement

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Mobile Self-Management of Irritable Bowel Syndrome for Adolescents

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