Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02224430|
Recruitment Status : Active, not recruiting
First Posted : August 25, 2014
Last Update Posted : April 22, 2019
|Condition or disease|
|Schizophrenia Schizoaffective Disorder|
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|
|Actual Enrollment :||40 participants|
|Observational Model:||Ecologic or Community|
|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|
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.
- 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.
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
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Adrienne C Lahti, MD||University of Alabama at Birmingham|