Trial Outcomes & Findings for Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods (NCT NCT02418910)

NCT ID: NCT02418910

Last Updated: 2019-04-01

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2019-04-01

Participant Flow

Participant milestones

Measure	Bipolar Outpatients in Any Clinical State Patients with Bipolar Disorder. Study does not provide a treatment intervention.
Overall Study STARTED	50
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Bipolar Outpatients in Any Clinical State Patients with Bipolar Disorder. Study does not provide a treatment intervention.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bipolar Outpatients in Any Clinical State - KIOS or eMoods n=43 Participants Patients with Bipolar Disorder. Study does not provide a treatment intervention.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Bipolar Outpatients in Any Clinical State n=43 Participants Patients with Bipolar Disorder. Study does not provide a treatment intervention.
Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs	43 Participants

Adverse Events

Bipolar Outpatients in Any Clinical State

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gregg Siegel

Biomedical Development Corporation

Phone: 2108638053

Email: gsiegel@biodevcorp.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place