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Self-Management Assistance for Recommended Treatment (SMART) Portal (SMART)

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ClinicalTrials.gov Identifier: NCT01966744
Recruitment Status : Completed
First Posted : October 22, 2013
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
The purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. This study aims to build and revise the SMART portal according to feedback and testing from participants.

Condition or disease
Crohn's Disease Ulcerative Colitis Indeterminate Colitis Inflammatory Bowel Disease

Detailed Description:
The study consists of three phases for development and evaluation of the SMART portal. Phase 1 is the development of online assessments and intervention components. There will be no participant interaction with the portal during Phase 1. Phase 2 will consist of one, individual interview with patients, caregivers, and clinicians/nurses to interact with a portal prototype and provide feedback. Phase 3 will contain an open trial for patients and caregivers with baseline, 2-6 months interacting with the portal and progressing through applicable intervention components, and post-treatment. Patient test data will also be loaded into the portal during Phase 3 for clinicians/nurses to interact with for 2-6 months. Feedback from all users will be collected at post-treatment for optimization of the portal.

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Self-Management Assistance for Recommended Treatment (SMART) Portal
Study Start Date : July 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Clinicians/Nurses
Clinicians and nurses who treat patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization.
Patients
Patients age 11-18 years diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization.
Caregivers
Caregivers of patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization.



Primary Outcome Measures :
  1. Medication adherence [ Time Frame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components ]
    Medication adherence will be measured by pill count data provided by patients or caregivers at baseline and post-treatment during Phase 3. Phase 3 will start approximately in October 2014 and continue through March 2015.


Secondary Outcome Measures :
  1. Disease severity [ Time Frame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components ]
    Disease severity will be measured at baseline, post-treatment, and periodically throughout the intervention as the patient logs in to view intervention materials during Phase 3. The portal will prompt the patient to complete disease severity questions throughout the intervention, but it will be dependent upon the patient actually logging into the system. Therefore, exact time points during treatment are unknown. The Pediatric Ulcerative Colitis Activity Index (PUCAI) will be used to measure disease severity for patients diagnosed with ulcerative colitis and indeterminate colitis, and the Partial Harvey Bradshaw (PHBI) will be used for patients diagnosed with Crohn's disease. Phase 3 will start approximately in October 2014 and continue through March 2015.

  2. Health-related quality of life [ Time Frame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components ]
    The IMPACT-III will be used during baseline and post-treatment in Phase 3 to measure quality of life in patients. Phase 3 will start approximately in October 2014 and continue through March 2015.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, caregivers, clinicians, and nurses will be recruited from the IBD clinic at Cincinnati Children's Hospital Medical Center.
Criteria

Inclusion Criteria:

  • Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively known as IBD)
  • Patient between 11 and 18 years of age
  • Patient prescribed at least one oral medication used to treat IBD
  • Access to the internet whether public (example, library) or private (example, home, personal)
  • English fluency for patient, caregiver, and clinician/nurse
  • Clinician/nurse currently providing medical treatment to patients diagnosed with IBD through the IBD Center at Cincinnati Children's Hospital Medical Center

Exclusion Criteria:

  • Diagnosis of pervasive developmental disorder in patient or caregiver
  • Diagnosis of serious mental illness (example, schizophrenia) in patient or caregiver

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): NCT01966744


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Virginia
BeHealth Solutions, LLC
Charlottesville, Virginia, United States, 22901
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Chair: Lee Denson, M.D. Children's Hospital Medical Center, Cincinnati
Study Chair: James Peugh, Ph.D. Children's Hospital Medical Center, Cincinnati
Study Chair: Korey Hood, Ph.D. University of California, San Francisco
Study Chair: Lee Ritterband, Ph.D. BeHealth Solutions, LLC.

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01966744     History of Changes
Other Study ID Numbers: SMART
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases