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

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ClinicalTrials.gov Identifier: NCT02224430
Recruitment Status : Active, not recruiting
First Posted : August 25, 2014
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Dr. Adrianne C Lahti, University of Alabama at Birmingham

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.

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Official Title: Remote Physiological, Behavioral and Symptom Assessment Study to Identify Predictors of Symptom Exacerbation and Relapse in Schizophrenia
Study Start Date : August 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
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.



Primary Outcome Measures :
  1. Relapse or exacerbation of symptoms in schizophrenia/schizoaffective disorder [ Time Frame: up to 16 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
schizophrenia/schizoaffective disorder
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224430


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Janssen Research & Development, LLC
Investigators
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Principal Investigator: Adrienne C Lahti, MD University of Alabama at Birmingham

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Responsible Party: Dr. Adrianne C Lahti, Patrick H. Linton Professor and Director of the Division of Behavioral Neurobiology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02224430     History of Changes
Other Study ID Numbers: OBSERVESCH4001
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr. Adrianne C Lahti, University of Alabama at Birmingham:
biomarker of relapse
schizophrenia
schizoaffective disorder
on-body sensors
smartphone
observational
Additional relevant MeSH terms:
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Recurrence
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes