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

NCT02418910 | Completed Results

• 1 other identifier: HSC20150321
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

bipolar; self assessment; prospective randomized trial

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Study Arms (1)

bipolar outpatients

Patients with Bipolar Disorder in any clinical state

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male or female outpatients 18 years of age or older
• Bipolar I or II disorder as assessed by MINI 6.0
• In psychiatric outpatient treatment at UTHSCSA, University of Louisville, or Lindner Center of Hope, Mason Ohio
• Currently taking mood stabilizer or second generation antipsychotic for 4 weeks or longer
• Ability to access Kios-Bipolar or eMoods (via computer, smartphone or tablet)

You may not qualify if:

• Unwilling or unable to comply with study requirements
• Renal impairment (serum creatinine \>1.5 mg/dl
• If on thyroid medication must be euthyroid for at least 1 month
• Drug/alcohol dependence within the past 30 days

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Biomedical Development Corporation: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Gregg Siegel
• Organization: Biomedical Development Corporation

gsiegel@biodevcorp.com

2108638053

Study Officials

• Charles Bowden, M.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 17, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 1, 2019
• Results First Posted: April 1, 2019

Record last verified: 2018-08

Locations

US (1)