Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care
CCM
1 other identifier
interventional
400
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedStudy Start
First participant enrolled
August 3, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2029
Study Completion
Last participant's last visit for all outcomes
April 30, 2030
April 23, 2026
April 1, 2026
3.2 years
April 17, 2026
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute care utilization
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.
9 months
Secondary Outcomes (7)
Interpersonal supports - Interpersonal Support Evaluation List (ISEL)
9 months
Patient activation - Patient Activation Measure (PAM)
9 months
Engagement with care - Working Alliance Inventory (WAI)
9 months
Receipt of care appropriate for chronic conditions - Patient Assessment of Chronic Illness Care (PACIC)
9 months
Care experience - Ambulatory Care Experiences Survey (ACES)
9 months
- +2 more secondary outcomes
Study Arms (2)
CCM
ACTIVE COMPARATORMobile monitoring, peer coaching, and enhanced care coordination
Usual care
NO INTERVENTIONUsual care services
Interventions
Mobile monitoring, peer coaching, and enhanced care coordination
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Stehle Young, MD MSHS
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessors are not informed of the participant's participation in intervention or control
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2026
First Posted
April 23, 2026
Study Start (Estimated)
August 3, 2026
Primary Completion (Estimated)
October 31, 2029
Study Completion (Estimated)
April 30, 2030
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Final datasets will be stored on the local secure VA Research server for the period required by the VA Records Control Schedule. Analytic datasets will be made available in accordance with local and national VA policy and compliance regulations.
- Access Criteria
- Mechanisms for sharing datasets will be based on infrastructure and resources available through either the local VA facility or VHA nationally. Researchers interested in accessing datasets will be required to sign a Data Use Agreement.
A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Analytic datasets will be made available in accordance with local and national VA policy and compliance regulations. Mechanisms for sharing datasets will be based on infrastructure and resources available through either the local VA facility or VHA nationally. Researchers interested in accessing datasets will be required to sign a Data Use Agreement. Preservation and sharing of analytic datasets will allow other researchers to replicate published results and/or perform additional analyses. Researchers will be provided with a limited dataset as well as documentation regarding methods used for dataset creation and analytic procedures.