Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 19 - 45 |
| Updated: | 7/5/2018 |
| Start Date: | August 2014 |
| End Date: | December 31, 2018 |
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.
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.
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.
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.
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
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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