Trial Outcomes & Findings for A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia (NCT NCT01952041)

NCT ID: NCT01952041

Last Updated: 2019-06-21

Results Overview

A count of participants who experienced relapse, as defined as one of the following events: psychiatric hospitalization, a significant increase in the level of psychiatric care (i.e. frequency and intensity of services), an increase in medication in addition to a 25% increase in Brief Psychiatric Rating Scale (BPRS) from last assessment, suicidal or homicidal ideation that was clinically significant in the investigator's judgement, deliberate self-injury, violent behavior resulting in damage to another person or property.

Recruitment status

COMPLETED

Study phase

Target enrollment

149 participants

Primary outcome timeframe

1 year

Results posted on

2019-06-21

Participant Flow

Eligible individuals at a medical clinic were identified through electronic medical records and approached by a staff member to be recruited for the study. Recruitment was open from March 2015 until July 2016.

N=23 participants withdrew before randomization: N=1 did not complete baseline, N=15 no longer receiving services at the study site, N=1 incarcerated, N=6 no longer interested in participating.

Participant milestones

Participant milestones
Measure	Device: Smartphone Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.	Treatment as Usual Treatment as usual included outpatient case management, linkage to services and medication monitoring.
Overall Study STARTED	62	64
Overall Study COMPLETED	45	43
Overall Study NOT COMPLETED	17	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Device: Smartphone Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.	Treatment as Usual Treatment as usual included outpatient case management, linkage to services and medication monitoring.
Overall Study Lost to Follow-up	9	16
Overall Study Withdrawal by Subject	7	5
Overall Study Death	1	0

Baseline Characteristics

A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device: Smartphone n=62 Participants Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.	Treatment as Usual n=64 Participants Treatment as usual included outpatient case management, linkage to services and medication monitoring.	Total n=126 Participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION 14 • n=5 Participants	36 years STANDARD_DEVIATION 13 • n=7 Participants	37 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	49 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Device: Smartphone n=62 Participants Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.	Treatment as Usual n=64 Participants Treatment as usual included outpatient case management, linkage to services and medication monitoring.
Relapses in Participants	20 Participants	22 Participants

PRIMARY outcome

Timeframe: From randomization date until first relapse (evaluated approximately every 3 months until their last study visit which occurred approximately 12 months from randomization for those who completed the study).

Time to first relapse was defined as the time from randomization until the first relapse. Participants who did not experience a relapse were censored at their last known time relapse-free. Time-to-first relapse was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Device: Smartphone n=62 Participants Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.	Treatment as Usual n=64 Participants Treatment as usual included outpatient case management, linkage to services and medication monitoring.
Time to Relapse	13.8 months Not enough participants relapsed to calculate the upper and lower 95% confidence interval (CI).	NA months Interval 9.7 to In the treatment as usual group (TAU), the median from the time-to-event analysis was not reached (that is, at least 50% of people did not relapse). Not enough participants relapsed to calculate the upper 95% confidence interval (CI).

SECONDARY outcome

Timeframe: Assessed at baseline and every three months for one year.

Psychotic symptom severity assessed using the Brief Psychiatric Rating Scale (BPRS). This is an 18-item scale that rates severity of positive symptoms (including auditory hallucinations and persecutory ideation), and mood and behavioral symptoms. Items are rated by a clinical assessor on a scale of 1 (absent) to 7 (very severe). Total scores range from 18-126. Higher scores indicate worse symptoms.

Outcome measures

Outcome measures
Measure	Device: Smartphone n=62 Participants Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.	Treatment as Usual n=64 Participants Treatment as usual included outpatient case management, linkage to services and medication monitoring.
Psychotic Symptom Severity baseline	26.3 score on a scale Standard Deviation 7.2	27.4 score on a scale Standard Deviation 8.2
Psychotic Symptom Severity 3 months	24.9 score on a scale Standard Deviation 6.4	25.3 score on a scale Standard Deviation 5.3
Psychotic Symptom Severity 6 months	25.3 score on a scale Standard Deviation 6.5	23.7 score on a scale Standard Deviation 5.1
Psychotic Symptom Severity 9 months	25.6 score on a scale Standard Deviation 6.4	24.0 score on a scale Standard Deviation 5.6
Psychotic Symptom Severity 12 months	25.0 score on a scale Standard Deviation 7.7	26.3 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Assessed at baseline and every three months for one year.

Depression measured using the Calgary Depression Scales (CDSS). This is a 9-item assessment with values of 0 (absent) to 3 (severe) of depressive symptoms separate from positive, negative and extrapyramidal symptoms in people with schizophrenia. Total scores range from 0-27. A higher score indicates more severe symptoms.

Outcome measures

Outcome measures
Measure	Device: Smartphone n=62 Participants Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.	Treatment as Usual n=64 Participants Treatment as usual included outpatient case management, linkage to services and medication monitoring.
Depression baseline	1.4 score on a scale Standard Deviation 2.0	2.1 score on a scale Standard Deviation 2.7
Depression 3 months	1.7 score on a scale Standard Deviation 2.2	1.7 score on a scale Standard Deviation 2.1
Depression 6 months	1.4 score on a scale Standard Deviation 2.3	1.7 score on a scale Standard Deviation 2.3
Depression 9 months	2.1 score on a scale Standard Deviation 2.6	1.7 score on a scale Standard Deviation 2.0
Depression 12 months	1.4 score on a scale Standard Deviation 2.2	2.5 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Assessed at baseline and every three months for one year.

Social Functioning was assessed using the Social Functioning Scale (SFS). This is a 76-item questionnaire that assesses various aspects of social functioning and generates a number of subscale scores including social withdrawal, interpersonal behavior, pro-social activities, and an overall score of social functioning. The item values range from 0 (almost never) to 3 (often). Total scores range from 0-228. A higher score indicates greater social functioning.

Outcome measures

Outcome measures
Measure	Device: Smartphone n=62 Participants Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.	Treatment as Usual n=64 Participants Treatment as usual included outpatient case management, linkage to services and medication monitoring.
Social Functioning baseline	142.0 score on a scale Standard Deviation 29.0	135.1 score on a scale Standard Deviation 30.2
Social Functioning 3 months	144.9 score on a scale Standard Deviation 30.3	140.0 score on a scale Standard Deviation 27.2
Social Functioning 6 months	145.8 score on a scale Standard Deviation 27.2	140.1 score on a scale Standard Deviation 28.1
Social Functioning 9 months	134.5 score on a scale Standard Deviation 30.5	143.2 score on a scale Standard Deviation 28.0
Social Functioning 12 months	138.1 score on a scale Standard Deviation 27.9	141.1 score on a scale Standard Deviation 26.1

Adverse Events

Device: Smartphone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Treatment as Usual

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

Dror Ben-Zeev, PhD

University of Washington School of Medicine

Phone: (206) 685-9655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place