Bipolar Disorder
Conditions
Keywords
bipolar, self assessment, prospective randomized trial
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.
Interventions
None listed
Sponsors
Biomedical Development Corporation
The University of Texas Health Science Center at San Antonio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bipolar Outpatients in Any Clinical State - KIOS or eMoods Patients with Bipolar Disorder. Study does not provide a treatment intervention. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Bipolar Outpatients in Any Clinical State - KIOS or eMoods |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age, Continuous | 43 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs
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.
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bipolar Outpatients in Any Clinical State | Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs | 43 Participants |