NCT02418910

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

Comparative Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods: A Randomized, Open 52 Week Study for Persons With Bipolar Disorder

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-04-17
• Last updated: 2019-04-01
• Results posted: 2019-04-01

Locations

1 site across 1 country: United States