SchizophreniaNCT02224430
Prediction of Relapse in Schizophrenia/Schizoaffective Disorder With Smartphones and On-body Sensors
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- schizophrenia/schizoaffective disorder.
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: schizophrenia/schizoaffective disorder
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the 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
- Being tested
- schizophrenia/schizoaffective disorder.
- Keywords
- biomarker of relapse, schizophrenia, schizoaffective disorder, on-body sensors, smartphone, observational
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
schizophrenia/schizoaffective disorder.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.
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia/schizoaffective disorder | Participants with schizophrenia/schizoaffective disorder. Receives: Device: schizophrenia/schizoaffective disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Principal investigator, Dr. Adrianne C Lahti, University of Alabama at Birmingham
- Investigators
- Adrienne C Lahti, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224430
- Sponsor's protocol ID
- OBSERVESCH4001
- Status last verified
- Jul 2021
- First submitted
- 12 Aug 2014
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 34383682
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Physiological, Behavioral and Symptom Assessment Study to Identify Predictors of Symptom Exacerbation and Relapse in Schizophrenia
- ClinicalTrials.gov ID
- NCT02224430
- Acronym / sponsor ID
- OBSERVESCH4001
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- biomarker of relapse, schizophrenia, schizoaffective disorder, on-body sensors, smartphone, observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Aug 2014
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| schizophrenia/schizoaffective disorder | – | Device: schizophrenia/schizoaffective disorder.Participants with schizophrenia/schizoaffective disorder. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- schizophrenia/schizoaffective disorder
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | schizophrenia/schizoaffective disorder |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 34383682Lahti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne C Lahti, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse or exacerbation of symptoms in schizophrenia/schizoaffective disorder (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02224430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.