Psychosis Clinical Trial
— RWJFGingerOfficial title:
Using Mobile Technology To Detect Early Warning Signs of Mental Health Challenges and Enhance Treatment Delivery For Youth
Verified date | October 2017 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project tests the feasibility of implementing a smartphone application - Ginger.io - in
the UC Davis Early Psychosis Program, and investigates whether mobile health technology can
improve treatment delivery and outcomes in individuals with early psychosis. Ginger.io is a
smartphone application that utilizes methods of passive data collection (i.e. data gathered
without active interaction/contribution from the user) to gather communication, movement, and
interaction data from smartphone devices to model individuals' social, physical, and mental
health. These models are used to infer health-related outcomes and could inform treatment. By
implementing the Ginger.io application in the UC Davis Early Psychosis Program with an
integrated clinical and research infrastructure, the investigators will be able to quickly
determine its feasibility for use in early psychosis populations, while simultaneously
developing its ability to systematically capture aspects of relapse and recovery that are
unique to this patient population.
Objectives: This project has three principle objectives related to early psychosis care: 1)
improve treatment delivery, 2) improve patient outcomes, and 3) lower treatment costs. The
project will target individuals in the early stages of psychotic illness, including
individuals at high risk for developing a psychotic illness (termed "clinical high risk" or
CHR) and individuals within three years of their first psychotic episode (termed "first
episode psychosis" or FEP). The early stages of psychotic illness represent a critical period
for intervention; early identification of clinical deterioration and subsequent targeted
intervention is crucial for rapid remission of symptoms and reduced relapse rates. However,
without the information necessary to identify patients in need of such intervention,
providers are limited in their ability to respond rapidly. Within the UCD Early Psychosis
Program, a mobile health application such as Ginger.io has the potential to equip the
providers and caregivers with valuable insight into a patient's status in real-time without
the burden of increased appointments and intrusive monitoring, allowing the identification of
early psychosis patients most in need of outreach, and routing of treatment resources to the
right patients at the right time.
Status | Completed |
Enrollment | 79 |
Est. completion date | November 1, 2015 |
Est. primary completion date | November 1, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Ages 13-30, English fluency Exclusion Criteria: - IQ Below 70, history of neurological disorders, or current substance abuse/dependence. |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Imaging Research Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Ginger.io |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of using the Ginger.io app | measured by number of enrolled and active participants versus total patient population invited | end of study, maximum of 18 months | |
Primary | Acceptability of the Ginger.io app | Measured with satisfaction survey ratings of Ginger.io by patients and clinicians. | 6 months | |
Primary | Brief Psychiatric Rating Scale (BPRS) | Brief Psychiatric Rating Scale (BPRS) is a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety. | through study completion, maximum of 18 months | |
Primary | Global Functioning Scale:Social | Global Functioning Scale: Social provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale. | through study completion, maximum of 18 months | |
Primary | Critical Incidents | Count of clinic contacts, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis. | through study completion, maximum of 18 months | |
Primary | CGI | The CGI (Haro et al., 2003) is a brief 12-item scale assessing illness severity and degree of improvement over follow-up that is appropriate for use in clinical or research settings. | through study completion, maximum of 18 months | |
Primary | Global Assessment of Functioning | The GAF is a numeric scale (0 through 100) that provides a rating of an individual's social, occupation, and psychological functioning. | through study completion, maximum of 18 months | |
Primary | Global Functioning Scale: Role | Global Functioning Scale: Role provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale. | through study completion, maximum of 18 months | |
Secondary | Medication Adherence (MARS) | The MARS is a 10-item self-report questionnaire assessing medication taking behavior, attitudes to medication, and side effects. | through study completion, maximum of 18 months | |
Secondary | Therapeutic Alliance | Therapeutic alliance will be assessed with the STAR (Mcguire-Snieckus et al., 2007), a 12-item questionnaire with patient and clinician versions assessing positive collaboration and positive clinician input (both versions), non-supportive input (patient version), and emotional difficulties (clinician version). | through study completion, maximum of 18 months | |
Secondary | Insight | Patient's insight into their illness will be assessed using the IS (Birchwood et al., 1994), an 8-item self-report questionnaire assessing awareness of illness, need for treatment, and attribution of symptoms. | through study completion, maximum of 18 months | |
Secondary | Clinically relevant patient alerts | Clinician responses to patient alerts within the Ginger.io Dashboard, indicating response to alert and whether it was clinically relevant | through study completion, maximum of 18 months | |
Secondary | Cost of Care | The historical average monthly and annual cost of care per patient will be compared to the average monthly and annual cost of care during and following completion of the project. | through study completion, maximum of 18 months |
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