A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

NCT01952041 | Completed Results DMC

• 1 other identifier: MH103148-01 D14022
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a 2-arm randomized control trial (RCT) designed to test a multi-modal smartphone data collection system that provided mobile monitoring of schizophrenia to detect early signs of relapse. The RCT compared an arm with participants who received treatment as usual with an arm that received the smartphone system for a year.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Mobile Application; Relapse; SMI; EHealth; E-Health; Health Technology; mHealth; m-Health; Mobile Health; Serious Mental Illness; Electronic Health

Outcome Measures

Primary Outcomes (2)

• Relapses in Participants

  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.

  1 year

• Time to Relapse

  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.

  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).

Secondary Outcomes (3)

• Psychotic Symptom Severity

  Assessed at baseline and every three months for one year.

• Depression

  Assessed at baseline and every three months for one year.

• Social Functioning

  Assessed at baseline and every three months for one year.

Study Arms (2)

Device: Smartphone

EXPERIMENTAL

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.

Behavioral: Device: Smartphone

Treatment as Usual

ACTIVE COMPARATOR

Treatment as usual included outpatient case management, linkage to services and medication monitoring.

Behavioral: Treatment as usual

Interventions

Device: Smartphone BEHAVIORAL

Device: Smartphone

Treatment as usual BEHAVIORAL

Treatment as Usual

Eligibility Criteria

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

You may qualify if:

• Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for schizophrenia, schizoaffective disorder, or psychosis not otherwise specified based on a chart diagnosis
• years or older
• An inpatient psychiatric hospitalization, daytime psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital emergency room within 12 months before study entry
• Willing and able to provide informed consent

You may not qualify if:

• Hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using a demonstration smartphone for screening)
• th grade reading level (determined by Wide Range Achievement Test- 4th Edition)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Recurrence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dror Ben-Zeev, PhD
• Organization: University of Washington School of Medicine

dbenzeev@uw.edu

(206) 685-9655

Study Officials

• Dror Ben-Zeev, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded clinical assessors also conducted assessments with all participants at baseline and every 3 months post-randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 27, 2013
• Study Start: March 13, 2015
• Primary Completion: August 7, 2017
• Study Completion: August 7, 2017
• Last Updated: June 21, 2019
• Results First Posted: June 21, 2019

Record last verified: 2019-03

Locations

US (1)