An interventional study of Care Coordination Mobile in Severe Mental Illness, sponsored by VA Office of Research and Development. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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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.
Overview: Providing care to individuals with serious mental illness (SMI) 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. A variety of 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. This project studies, in Veterans with SMI and high risk for acute care, the effectiveness of an enhanced care coordination mobile intervention (CCM) that uses passive mobile data and support from peer coaches. The investigators hypothesize that CCM will reduce the need for acute care services in comparison to usual care.
Specific Aims:
Among Veterans with SMI:
Methodology:
Population: patients with SMI and high risk for acute care use. Intervention: enhanced care coordination within a VA BHIP program using passive mobile monitoring and supports from peer coaches Comparison: effectiveness trial with randomization to CCM or usual care for 9 months Outcome: reduction in use of urgent care services (emergency visits, hospitalization, or death) Qualitative and quantitative methods
1,745 studies on the registry are indexed under Mental Disorders; 353 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 1,304 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →VA Office of Research and Development is the lead sponsor of 1,773 studies on the registry; 393 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
a medical record diagnosis of Serious Mental Illness (SMI)
Exclusion Criteria:
Mobile monitoring, peer coaching, and enhanced care coordination
Behavioral: Care Coordination Mobile
Usual care services
Mobile monitoring, peer coaching, and enhanced care coordination
Also known as: CCM
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.
Time frame: 9 months
Interpersonal supports - Interpersonal Support Evaluation List (ISEL)
Level of social support measured using the Interpersonal Support Evaluation List-12 (ISEL). Scores can range from 0 to 36, with higher scores indicating a better outcome.
Time frame: 9 months
Patient activation - Patient Activation Measure (PAM)
Patient activation measured using the short-form Patient Activation Measure (PAM-13). Scores can range from 13 to 52, with higher scores indicating a better outcome.
Time frame: 9 months
Engagement with care - Working Alliance Inventory (WAI)
Engagement with care measured using the Working Alliance Inventory for General Practice (WAI-GP). Scores can range from 12 to 60, with higher scores indicating a better outcome.
Time frame: 9 months
Receipt of care appropriate for chronic conditions - Patient Assessment of Chronic Illness Care (PACIC)
Receipt of care appropriate for chronic conditions measured using the 20-item Patient Assessment of Chronic Illness Care (PACIC). Scores can range from 20 to 100, with higher scores indicating a better outcome.
Time frame: 9 months
Care experience - Ambulatory Care Experiences Survey (ACES)
Care experience measured using the Ambulatory Care Experiences Survey (ACES) Short Form. Scores can range from 0 to 100, with higher scores indicating a better outcome.
Time frame: 9 months
Psychiatric symptoms - Behavior And Symptom Identification Scale (BASIS-24)
Psychiatric symptoms measured using the Behavior And Symptom Identification Scale (BASIS-24). Scores can range from 0 to 96, with higher scores indicating worse outcomes.
Time frame: 9 months
Quality of life - Veterans RAND 12 item Health Survey (VR-12)
Health-related quality of life measured using the Veterans RAND 12 item Health Survey (VR-12). Scores can range from 0 to 100, with higher scores indicating a better outcome.
Time frame: 9 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Oct 2029, 38 months after the start.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 38 months is above that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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