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

January 3, 2019 updated by: The University of Texas Health Science Center at San Antonio

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
bipolar outpatients
Patients with Bipolar Disorder in any clinical state

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs
Time Frame: 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.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Biomedical Development Corporation

Investigators

  • Principal Investigator: Charles Bowden, M.D., University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20150321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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