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Trial record 25 of 568 for:    applied AND irritation

Mobile Self-Management of Irritable Bowel Syndrome for Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03138980
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
BodiMojo, Inc.
Information provided by (Responsible Party):
Lonnie Zeltzer, University of California, Los Angeles

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Abdominal Pain Behavioral: BodiMojo Buddy for IBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mobile Self-Management of Irritable Bowel Syndrome for Adolescents: Pilot Study
Actual Study Start Date : January 30, 2016
Actual Primary Completion Date : September 22, 2016
Actual Study Completion Date : September 22, 2016

Arm Intervention/treatment
Experimental: Mobile application Behavioral: BodiMojo Buddy for IBS
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 Measures :
  1. Ratio of the days during the 30-day intervention period during which participants use the app [ Time Frame: 30 days (from day 1 through day 30 of the 30-day intervention period) ]
    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.

  2. Acceptance [ Time Frame: Within 7 days of competing the intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138980


Locations
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United States, California
UCLA Pediatric Pain Program Research Offices
Los Angeles, California, United States, 90064
Sponsors and Collaborators
University of California, Los Angeles
BodiMojo, Inc.

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Responsible Party: Lonnie Zeltzer, Professor, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03138980     History of Changes
Other Study ID Numbers: 15-001825
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Abdominal Pain
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive