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

NCT ID: NCT02224430

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2019-12-31

Brief Summary

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.

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: OTHER

Study Groups

schizophrenia/schizoaffective disorder

Participants with schizophrenia/schizoaffective disorder.

schizophrenia/schizoaffective disorder.

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Dr. Adrianne C Lahti

Patrick H. Linton Professor and Director of the Division of Behavioral Neurobiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrienne C Lahti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34383682 (View on PubMed)

Other Identifiers

OBSERVESCH4001

Identifier Type: -

Identifier Source: org_study_id