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Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods

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ClinicalTrials.gov Identifier: NCT02418910
Recruitment Status : Completed
First Posted : April 17, 2015
Results First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Biomedical Development Corporation
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
The goal of this project is to complete the development of a patient-centered software system and mobile app to assist in managing bipolar disorder. In Phase I, the investigators developed a novel computational tool known as KIOS. Based on concepts from nonlinear systems (chaos) theory, KIOS tracks multiple interacting symptoms to determine the precise state of a BD patient. Once the patient's state is identified and the trajectory of the patient is established, KIOS produces advice specific to the patient's condition to help manage the course of the disease. To demonstrate the usability of the software, KIOS was converted to an online tool with mobile access. Twenty bipolar patients evaluated KIOS in a twelve week field trial. No technical problems with the software were observed and results showed that patients had significantly more reductions in symptom severity than increases. The development of this innovative tool to help patients self- manage BD has the potential to have a profound impact on public health and achieve significant commercial success.

Condition or disease
Bipolar Disorder

Detailed Description:

This Phase II study has the specific aim of evaluation of KIOS-Bipolar in a randomized, open 52 week effectiveness study of 120 bipolar subjects in current treatment at three socioeconomically diverse academic health science centers. Concurrent with this clinical effectiveness study, the research team, funded by the same NIH grant,will refine prototype software and integrate data security and establish quality standards into the KIOS-Bipolar system.

The clinical trial will:

Assess sensitivity of K-B assessed improvement or worsening by comparison with assessment by BISS-Self and BISS-42.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods: A Randomized, Open 52 Week Study for Persons With Bipolar Disorder
Study Start Date : October 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Group/Cohort
bipolar outpatients
Patients with Bipolar Disorder in any clinical state



Primary Outcome Measures :
  1. Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs [ Time Frame: 52 weeks ]
    measure is the count of participants with KIOS or eMOOD assessments completed on time, completed only with follow-up prompts, and the number of weeks not submitted.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This Phase II study has the specific aim of evaluation of KIOS-Bipolar in a randomized, open 52 week effectiveness study of 50 bipolar subjects in current treatment. Subjects are male or female, outpatient, 18 years of age or older, Bipolar I or II disorder as assessed by MINI 6.0, and in psychiatric outpatient treatment at UTHSCSA
Criteria

Inclusion Criteria:

  1. Male or female outpatients 18 years of age or older
  2. Bipolar I or II disorder as assessed by MINI 6.0
  3. In psychiatric outpatient treatment at UTHSCSA, University of Louisville, or Lindner Center of Hope, Mason Ohio
  4. Currently taking mood stabilizer or second generation antipsychotic for 4 weeks or longer
  5. Ability to access Kios-Bipolar or eMoods (via computer, smartphone or tablet)

Exclusion Criteria:

  1. Unwilling or unable to comply with study requirements
  2. Renal impairment (serum creatinine >1.5 mg/dl
  3. If on thyroid medication must be euthyroid for at least 1 month
  4. Drug/alcohol dependence within the past 30 days

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): NCT02418910


Locations
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United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Biomedical Development Corporation
Investigators
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Principal Investigator: Charles Bowden, M.D. University of Texas
  Study Documents (Full-Text)

Documents provided by The University of Texas Health Science Center at San Antonio:
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02418910    
Other Study ID Numbers: HSC20150321
First Posted: April 17, 2015    Key Record Dates
Results First Posted: April 1, 2019
Last Update Posted: April 1, 2019
Last Verified: August 2018
Keywords provided by The University of Texas Health Science Center at San Antonio:
bipolar
self assessment
prospective randomized trial
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders