Severe Mental IllnessCCMNCT07549178
Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care
A study testing Care Coordination Mobile in people with Severe Mental Illness, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Illness
- What is being tested?
- Care Coordination Mobile
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
Karina Montes, (215) 823-6046, Karina.Montesojeda@va.gov
David W Oslin, MD, (215) 823-5894, Dave.Oslin@va.gov
- Recruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Ronald Calderon, MSW, (310) 478-3711 ext. 46763, ronald.calderon@va.gov
Alexander S Young, MD MSHS, (310) 268-3416, Alexander.Young@va.gov
About this study
Official title: Care Coordination and Passive Mobile Data Monitoring to Engage Veterans and 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.
Read the detailed description
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
- Conditions
- Severe Mental Illness
- Being tested
- Care Coordination Mobile
- Keywords
- Mental Disorders, Severe, Veterans, Remote Sensing Technology, Mobile Applications, Patient Care Team, Continuity of Patient Care, Disease Management, Peer Coaching, Health Care Utilization
- Medical subject headings
- Mental Disorders, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Coordination MobileBehavioural
Also called CCM
Mobile monitoring, peer coaching, and enhanced care coordination
| Study group | Role | What they receive |
|---|---|---|
| CCM | Active comparator | Mobile monitoring, peer coaching, and enhanced care coordination Receives: Behavioral: Care Coordination Mobile |
| usual care | No intervention | Usual care services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start10 Aug 2026
- Primary completion31 Oct 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project studies the effectiveness of an enhanced care coordination mobile intervention (CCM) that uses passive mobile data monitoring and support from peer coaches.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alexander Stehle Young, MD MSHS, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549178
- Sponsor's protocol ID
- HSR4-022-24W
- Acronym
- CCM
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Coordination and Passive Mobile Data Monitoring to Engage Veterans and Improve Mental Health Care
- ClinicalTrials.gov ID
- NCT07549178
- Acronym / sponsor ID
- CCM / HSR4-022-24W
- Conditions
- Severe Mental Illness
- Keywords
- Mental Disorders, Severe, Veterans, Remote Sensing Technology, Mobile Applications, Patient Care Team, Continuity of Patient Care, Disease Management, Peer Coaching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This project studies the effectiveness of an enhanced care coordination mobile intervention (CCM) that uses passive mobile data monitoring and support from peer coaches.
| Arm | Type | Receives |
|---|---|---|
| CCM | Active comparator | Behavioral: Care Coordination MobileMobile monitoring, peer coaching, and enhanced care coordination |
| usual care | No intervention | –Usual care services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a medical record diagnosis of Serious Mental Illness (SMI)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Coordination MobileAlso: CCMMobile monitoring, peer coaching, and enhanced care coordination | Behavioural | CCM |
Primary outcome
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.
7 secondary outcomes
Interpersonal supports - Interpersonal Support Evaluation List (ISEL)
Time frame: 9 months
Patient activation - Patient Activation Measure (PAM)
Time frame: 9 months
Engagement with care - Working Alliance Inventory (WAI)
Time frame: 9 months
Receipt of care appropriate for chronic conditions - Patient Assessment of Chronic Illness Care (PACIC)
Time frame: 9 months
Care experience - Ambulatory Care Experiences Survey (ACES)
Time frame: 9 months
Psychiatric symptoms - Behavior And Symptom Identification Scale (BASIS-24)
Time frame: 9 months
Quality of life - Veterans RAND 12 item Health Survey (VR-12)
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Stehle Young, MD MSHS principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordination Mobile in people with Severe Mental Illness, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronald Calderon, MSW ((310) 478-3711 ext. 46763, ronald.calderon@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute care utilization (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.