Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | October 2015 |
| End Date: | April 2017 |
Comparative Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods: A Randomized, Open 52 Week Study for Persons With Bipolar Disorder
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.
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.
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.
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.
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
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Charles L Bowden, MD
Phone: 210-567-5393
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
Click here to add this to my saved trials
