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

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT02418910
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-17
• Study Start: 2015-10
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-08
• Results First Submitted: 2018-08-21
• Results First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Results First Posted: 2019-04-01
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States