Clinical trial NCT02418910: Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: bipolar
self assessment
prospective randomized trial
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Biomedical Development Corporation
First posted: 2015-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas
name: Charles Bowden, M.D.
role: PRINCIPAL_INVESTIGATOR
References: