Overview

This trial is active, not recruiting.

Condition bipolar disorder
Sponsor The University of Texas Health Science Center at San Antonio
Collaborator Biomedical Development Corporation
Start date October 2015
End date April 2017
Trial size 50 participants
Trial identifier NCT02418910, HSC20150321

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with Bipolar Disorder. Study does not provide a treatment intervention.

Primary Outcomes

Measure
Comparison of two brief assessment measures: KIOS Bipolar or eMOODs
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Comparative Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods: A Randomized, Open 52 Week Study for Persons With Bipolar Disorder
Principal investigator Charles Bowden, M.D.
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: 1. Assess aggregate time spent in seven primary clinical states of BD (remitted; subsyndromal depression, mania or mixed state; and syndromal depression, mania or mixed state). 2. Assess the weekly completion of KIOS-Bipolar and eMoods. 3. Determine indices of patient satisfaction with the format, ease of use, time required and patient motivation for continuing use of the patient tools both during the trial and following completion. 4. Determine patient satisfaction with the clinical information on BD illness trajectory and recommendations to facilitate good health and effective interventions. Note that eMoods does not provide this element of information, therefore no comparative data will be feasible for this one objective. 5. Assess patient scored life function indices (Life Function Questionnaire (LFQ) over the 52 week period of the study. 6. Assess the relationship between the 8 symptom items in K-B with relevant items rated both by clinicians and as self-assessments by patients at four time points (week 0, 8, 16 and 52) in the study. These are times at which clinical care visits will routinely occur, and therefore will not add either to extra burden on the participants, or extra contact time with staff. Subjects randomized to eMoods will be similarly scheduled, with the correlations limited to those feasible with the eMoods product. Self-assessments with the 29 item BISS-Self are routinely obtained as part of regular treatment visits. For subjects in this study the trained BISS rater will be blind to the tool assigned. The clinician administered scale will be the 42 item Bipolar Inventory of Symptoms Scale (BISS), however comparisons will be limited to the symptom areas represented in both K-B and eMoods, e.g., depression and mania subscales; depression, mania, irritability and anxiety domains. The BISS Self (BISS-S) is a 29 item scale covering similar symptoms to the BISS, but answered as yes/no, rather than the 0-4 range of the BISS. The MINI is a structured diagnostic interview providing current and lifetime psychiatric diagnoses, requiring approximately 20 minutes. 7. Estimate the utility of ancillary features of Kios-Bipolar or eMoods. These features include capability to submit to the investigative staff displays of symptom trajectories for the patient's medical record and visual displays of selected aspects of the patient's illness/wellness. No transmission of data to treating clinical staff will occur as component of this study. 8. Assess sensitivity of K-B assessed improvement or worsening by comparison with assessment by BISS-Self and BISS-42.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio.