Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors

Remote Physiological, Behavioral and Symptom Assessment Study to Identify Predictors of Symptom Exacerbation and Relapse in Schizophrenia

This study is dedicated to achieving a better understanding of how to identify patterns that indicate someone might be at high risk for relapse in schizophrenia or schizoaffective disorder. The investigators are utilizing smartphone technology along with on body sensors to achieve this goal. The study will observe participants behavior in their natural environment for a period of 16 weeks or until a signal of relapse is obtained. Participants will also complete scales in a clinical research environment biweekly.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Device: schizophrenia/schizoaffective disorder.

Detailed Description

This study will follow a group of participants who have recently been discharged from the emergency room or the hospital using several new "high-tech" methods, including the use of a smartphone, health and wellness wristbands/watches and an optional arm patch sensor. These devices (some of which are commercially available to the public for purchase), will capture ongoing physiological information including sweat gland activity, movement, skin temperature, heart rate, breathing rate, and sleep. The smart phone, and an installed application, will administer bidaily and weekly symptom assessment, track the general location of the participant, and collect statistics about text messaging and cell phone use.

In addition to the on-body devices participants will come into the clinical research office to complete clinical scales every other week. These scales will be used to determine symptom exacerbation or relapse. This signature will then be utilized as a marker to examine the data collected from the devices.

The investigators hope to go beyond clinical evaluation and identify a signature of relapse that is reliably detected from on body devices in a natural setting. This would cut down on the time it takes to successfully treat psychotic illnesses and would reduce the amount of pain and and suffering experienced by patients during relapse.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

schizophrenia/schizoaffective disorder

Description

Inclusion Criteria:

• DSM - 5 criteria for schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual (DSM) criteria
• Males and females 19 years or older
• Discharged from the University of Alabama at Birmingham (UAB) inpatient psychiatric unit or the emergency department (ER) or currently seen by UAB outpatient physicians
• Prescribed and maintained on antipsychotic medication
• Psychiatrically stable for a period of at least two weeks
• Willingness and capability to comply with the study procedures, including responding to smartphone application prompts, wearing the optional on-body electronic devices
• Each participant must activate the Ginger.io User License Agreement (ULA) indicating that he or she understands how data security will be maintained on the smartphones.
• Each participant must sign an Informed Consent (ICF) indicating that he or she understands the purpose of the procedures required for the study and are willing to participate in the study

Exclusion Criteria:

• Physical and or clinical disabilities such as hearing, vision, or motor impairment, which make it impossible to operate a smartphone or respond to prompts (determined using demonstration smartphone for screening)
• Inability to understand the consent process as determined by the Evaluation to Give Consent
• Substance Use Disorder rating of severe (6 or more symptoms) according to the DSM-5
• Participants with any known skin allergy to the use of adhesives and/or lithium will be excluded from the optional Metria patch segment of the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
schizophrenia/schizoaffective disorder; Participants with schizophrenia/schizoaffective disorder.	Device: schizophrenia/schizoaffective disorder.; Participants with schizophrenia/schizoaffective disorder will be observed remotely and at weekly/biweekly laboratory visits over a period of 16 weeks or until relapse occurs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse or exacerbation of symptoms in schizophrenia/schizoaffective disorder	To determine patterns of risk for relapse appropriate model will be used considering factors such as, but not limited to, medication compliance, accelerometry / physical activity, skin temperature, continuity of sleep, duration of sleep, engagement with others through text and talk, changes in geographic range, daily questionnaire responses, cognitive symptom, impulsivity and psychosocial functioning scales.	up to 16 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Janssen Research & Development, LLC
• Investigators: Principal Investigator: Adrienne C Lahti, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Lahti AC, Wang D, Pei H, Baker S, Narayan VA. Clinical Utility of Wearable Sensors and Patient-Reported Surveys in Patients With Schizophrenia: Noninterventional, Observational Study. JMIR Ment Health. 2021 Aug 9;8(8):e26234. doi: 10.2196/26234.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: schizophrenia; schizoaffective disorder; smartphone; observational; biomarker of relapse; on-body sensors
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Recurrence
• Other Study ID Numbers: OBSERVESCH4001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes