NCT07549178 · VA Office of Research and Development
Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care
(CCM)
What this study is about
Providing care to individuals with serious mental illness can be challenging, requiring ongoing monitoring, treatment adjustments, and coordination of various medical and social services. Rates of emergency service and hospital use are high due to unexpected social, medical, and mental health crises.
View original scientific description
Providing care to individuals with serious mental illness can be challenging, requiring ongoing monitoring, treatment adjustments, and coordination of various medical and social services. Rates of emergency service and hospital use are high due to unexpected social, medical, and mental health crises. Stressors and poor adherence with treatment are common and can lead to rapid worsening in symptoms, job loss, homelessness, incarceration, or suicide. Clinician visits can be infrequent. Patient-clinician contact between visits is challenging and often nonexistent. As such, illness exacerbations usually occur with no clinician awareness in real time, leaving limited opportunity to provide services. Clinicians need interventions that are capable of monitoring and quickly detecting worsening behaviors and illness, to improve care coordination, outreach, and treatment. This project studies the effectiveness of enhanced care coordination using passive mobile data monitoring and support from peer specialists, with the goal of improving outcomes and reducing the need for acute care.
Interventions
BEHAVIORAL
Care Coordination Mobile
Mobile monitoring, peer coaching, and enhanced care coordination
Primary outcome measures
Acute care utilization
Time frame: 9 months
Use of emergency service, use of hospitals, and death are each a binary measure (yes/no). These will be combined to make one binary measure that is yes if any one of these three is yes, and otherwise no.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- a medical record diagnosis of Serious Mental Illness (SMI)
- defined as schizophrenia, schizoaffective disorder, or bipolar disorder
- receipt of care at the VA site during the prior 9 months
- a Care Assessment Need (CAN) score over the 75th percentile, indicating high risk for hospitalization or death in the upcoming year
- ownership of a smart phone
Where
- West Los Angeles, California
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations