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NCT Number: NCT07549178

Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care

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.

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Key information

Conditions

Severe Mental Illness Behavior Health Behavior Mental Disorders Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States

Loading trial locations.

About this study

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:

  • Engage Veterans and clinicians in co-design activities that adapt previously tested protocols and tools to guide implementation of enhanced care coordination with mobile (CCM intervention) that includes passive mobile monitoring of Veterans' mental health status, technology and behavioral supports from peer coaches, and care coordination within a Behavioral Health Interdisciplinary Program (BHIP).
  • Determine the effectiveness of CCM on acute care use. Implement CCM using protocols and tools from Aim 1 and randomize high-risk patients with SMI to CCM or usual care for 9 months.
  • Evaluate implementation of CCM.
  • Conduct a budget impact analysis of CCM.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • none

Treatment and study plan

Care Coordination Mobile

Behavioral

Mobile monitoring, peer coaching, and enhanced care coordination

Other names: CCM

Primary outcomes

  1. 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.

Secondary outcomes

  1. Interpersonal supports - Interpersonal Support Evaluation List (ISEL)

    Time frame: 9 months

    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.

  2. Patient activation - Patient Activation Measure (PAM)

    Time frame: 9 months

    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.

  3. Engagement with care - Working Alliance Inventory (WAI)

    Time frame: 9 months

    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.

  4. Receipt of care appropriate for chronic conditions - Patient Assessment of Chronic Illness Care (PACIC)

    Time frame: 9 months

    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.

  5. Care experience - Ambulatory Care Experiences Survey (ACES)

    Time frame: 9 months

    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.

  6. Psychiatric symptoms - Behavior And Symptom Identification Scale (BASIS-24)

    Time frame: 9 months

    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.

  7. Quality of life - Veterans RAND 12 item Health Survey (VR-12)

    Time frame: 9 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander S Young, MD MSHS

CONTACT

[email protected]

(310) 268-3416

Ronald Calderon, MSW

CONTACT

[email protected]

(310) 478-3711 ext. 46763

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Care Coordination and Passive Mobile Data Monitoring to Engage Veterans and Improve Mental Health Care

Acronym: CCM

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 23, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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