Mental Disorders, SevereBHHNCT05160701
Bringing Health Home
A study testing Medherent in people with Mental Disorders, Severe, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Individuals suffering from Serious Mental Illnesses (SMI) are at risk for serious adverse health and social outcomes compared to the general population due to a high prevalence of chronic physical health disorders such as cardiovascular disease, hypertension, and Type II Diabetes, along with consequences of mental… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Mental Disorders, Severe
- What is being tested?
- Medherent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to Sep 2026
- 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serious Mental Illness Diagnosis
- Prescribed psychiatric medications
- 18 to 80 years old
- Receives services by a participating community mental health agency at time of enrollment
- Be unable to consent to the study as assessed by the consent questionnaire.
- Sample 1: Current Users of Medherent or
- Sample 2: Willing or able to authorize to have the Medherent device in your residence
Who cannot join
- Unable to have the Medherent device in residence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bringing Health Home: Evaluation of a Residential-based Telehealth Care Coordination Intervention
Individuals suffering from Serious Mental Illnesses (SMI) are at risk for serious adverse health and social outcomes compared to the general population due to a high prevalence of chronic physical health disorders such as cardiovascular disease, hypertension, and Type II Diabetes, along with consequences of mental distress such as suicide, substance abuse, and acute stress.While pharmacological treatments exist for these conditions, they have limited effectiveness in SMI populations because: (1) up to 60% of individuals with SMI do not take their psychiatric or somatic medications as prescribed, (2) individuals with SMI have poorer clinical outcomes and experience high rates of hospitalizations, and (3) individuals with SMI experience worse care. Challenges in the management of these complex chronic health and mental health conditions have led to the development of intensive community-based service delivery programs. However, as currently structured these intensive in-person interventions have only had limited impact optimizing service delivery, and consequently on adherence to treatment and health outcomes. While in-person clinical contact in select situations is important, telehealth may serve as an effective and nimble intervention to help meet the high need for clinical intervention for SMI populations and particularly those with geographically limited-service access. Although research exists regarding the efficacy of telehealth with SMI populations, most of the existing interventions with this population have been designed for institutional settings, not community settings, because of barriers to adoption of telehealth such as limited access to digital technology, technical support difficulties and cost of necessary technology. The COVID-19 pandemic has underscored the need for developing effective telemedicine and telemonitoring technologies to serve the unique needs of this vulnerable population in community settings. This project builds on a successful Phase I SBIR project and ongoing Phase II clinical trial of the Medherent medication management platform. This study will test an expanded set of telehealth care-coordination services that can be used to address the broad health needs of individuals diagnosed with SMI living in community settings and supported by community mental health agencies. The study team will recruit 300 individuals, including 200 individuals currently using the device and 100 new users of the device. The study will test the existing Medherent platform and a set of extended services. Our key outcomes include acute service use, receipt of preventive and other health screenings, health outcomes and costs of services. The study will use a Stepped Wedge Design approach with a matched comparison group to identify potential benefits of the intervention.
- Conditions
- Mental Disorders, Severe
- Being tested
- Medherent
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedherentOther
Medherent is a telehealth adherence intervention platform designed for individuals with Serious Mental Illness living in the community. It is currently being used to dispense medication and monitor consumer adherence. It is a fully supported digital hub that is always on network connection and provides a cost- effective mechanism for increased care coordination through the Electronic Medication Record (EMR). The enhanced intervention will add collection of health data though Bluetooth connected devices, Telehealth medical visits and integrated algorithms that provide feed back to providers and consumers about health status.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care: no intervention elements. |
| Existing Medherent | Active comparator | Group using the Medherent Device with no added intervention components. Receives: Other: Medherent |
| New Medherent | Experimental | Group using Medherent Device with added interventional components. Receives: Other: Medherent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Service Utilization
The study team will use medical records and claims data to calculate monthly counts of outpatient/ambulatory care events, inpatient hospitalization, and Emergency Room or urgent care visits. The Healthcare Effectiveness Data and Information Set (HEDIS) tool will be used to identify preventable hospitalization or emergency room visits, follow up care after hospitalizations or emergency room visits.
Measured: Two years prior to study enrollment to at least one year after study enrollment.
Consumer Satisfaction STAR-P
Consumers self reports of services satisfaction with agency services. Scale is between 12 and 60. Higher scores are associated with higher satisfaction with services.
Measured: Change from Baseline to 6 months to 12 Months
Diabetes control as reported hemoglobin A1c levels
Reported hemoglobin A1c will be use to assess adherence to medication by modeling individual change change over time. A1C levels between 5.7 and less than 6.5% will be conferred as prediabetes range. A1C level of 6.5% or higher are considered in the diabetes range.
Measured: Two years prior to study enrollment to at least one year after study enrollment.
Reported Low-density lipoprotein (LDL)/High-density lipoprotein (HDL)
Reported Low-density lipoprotein (LDL)/High-density lipoprotein (HDL) will be use to assess adherence to medication by modeling individual change change over time. Normal HDL is 45 to 70 mg/dL for men and 50 to 90 mg/dL for women. The cutoff for good total cholesterol to HDL ratio is 5:1. Lower ratios are better than higher ratios.
Measured: Two years prior to study enrollment to at least one year after study enrollment.
High blood pressure.
Reported blood pressure will be use to assess adherence to medication by modeling individual change change over time. Scores will be considered normal if systolic is less than 120 mm Hg and diastolic less than 80 mm Hg. Scores will be considered elevated if systolic is 120-129 mm Hg and diastolic is less than 80 mm Hg. Scores will be considered evidence of hypertension if systolic is greater than 130 mm Hg and diastolic is more than 80 mm Hg.
Measured: Two years prior to study enrollment to at least one year after study enrollment.
Change in Health Service Costs
Costs of health services and mental health agency care will be calculated from Medicaid Claims data. These costs will be calculated for outpatient care, emergency room/urgent care, and inpatient hospitalization care by summing up all the costs of medical claims in each of these categories by month.
Measured: Two years prior to study enrollment to at least one year after study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start9 May 2022
- Primary completion15 Aug 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorders, SevereStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- To test our research aims we will use a stepped wedge cluster randomized design (SWD) and matched control group. All enrolled individuals will be grouped into a rollout unit. This unit could be comprised of individuals living in a group home or multiple group homes, a group of clients served by a case manager at an agency or a division of an agency. We anticipate that units will have approximately 10 - 15 clients and that we will have approximately 25 units across participating agencies. This design allows the study team to address problems with the rollout of the machines facilitating a good phase-in of the intervention for each unit. Third, this design addresses issues associated with the diffusion of the intervention within agencies that would occur with individual randomization while maintaining strong internal validity and assessment of the treatment effect.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Unick, University of Maryland, Baltimore
- Investigators
- George Unick, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160701
- Sponsor's protocol ID
- HP-00098021
- Acronym
- BHH
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2021
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bringing Health Home: Evaluation of a Residential-based Telehealth Care Coordination Intervention
- ClinicalTrials.gov ID
- NCT05160701
- Acronym / sponsor ID
- BHH / HP-00098021
- Conditions
- Mental Disorders, Severe
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Dec 2021 (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.
Individuals suffering from Serious Mental Illnesses (SMI) are at risk for serious adverse health and social outcomes compared to the general population due to a high prevalence of chronic physical health disorders such as cardiovascular disease, hypertension, and Type II Diabetes, along with consequences of mental distress such as suicide, substance abuse, and acute stress.While pharmacological treatments exist for these conditions, they have limited effectiveness in SMI populations because: (1) up to 60% of individuals with SMI do not take their psychiatric or somatic medications as prescribed, (2) individuals with SMI have poorer clinical outcomes and experience high rates of hospitalizations, and (3) individuals with SMI experience worse care. Challenges in the management of these complex chronic health and mental health conditions have led to the development of intensive community-based service delivery programs. However, as currently structured these intensive in-person interventions have only had limited impact optimizing service delivery, and consequently on adherence to treatment and health outcomes. While in-person clinical contact in select situations is important, telehealth may serve as an effective and nimble intervention to help meet the high need for clinical intervention for SMI populations and particularly those with geographically limited-service access. Although research exists regarding the efficacy of telehealth with SMI populations, most of the existing interventions with this population have been designed for institutional settings, not community settings, because of barriers to adoption of telehealth such as limited access to digital technology, technical support difficulties and cost of necessary technology. The COVID-19 pandemic has underscored the need for developing effective telemedicine and telemonitoring technologies to serve the unique needs of this vulnerable population in community settings. This project builds on a successful Phase I SBIR project and ongoing Phase II clinical trial of the Medherent medication management platform. This study will test an expanded set of telehealth care-coordination services that can be used to address the broad health needs of individuals diagnosed with SMI living in community settings and supported by community mental health agencies. The study team will recruit 300 individuals, including 200 individuals currently using the device and 100 new users of the device. The study will test the existing Medherent platform and a set of extended services. Our key outcomes include acute service use, receipt of preventive and other health screenings, health outcomes and costs of services. The study will use a Stepped Wedge Design approach with a matched comparison group to identify potential benefits of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- To test our research aims we will use a stepped wedge cluster randomized design (SWD) and matched control group. All enrolled individuals will be grouped into a rollout unit. This unit could be comprised of individuals living in a group home or multiple group homes, a group of clients served by a case manager at an agency or a division of an agency. We anticipate that units will have approximately 10 - 15 clients and that we will have approximately 25 units across participating agencies. This design allows the study team to address problems with the rollout of the machines facilitating a good phase-in of the intervention for each unit. Third, this design addresses issues associated with the diffusion of the intervention within agencies that would occur with individual randomization while maintaining strong internal validity and assessment of the treatment effect.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care: no intervention elements. |
| Existing Medherent | Active comparator | Other: MedherentGroup using the Medherent Device with no added intervention components. |
| New Medherent | Experimental | Other: MedherentGroup using Medherent Device with added interventional components. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Serious Mental Illness Diagnosis
- Prescribed psychiatric medications
- 18 to 80 years old
- Receives services by a participating community mental health agency at time of enrollment
- Be unable to consent to the study as assessed by the consent questionnaire.
Key exclusion criteria (1 listed)
- Unable to have the Medherent device in residence
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 |
|---|---|---|
| MedherentMedherent is a telehealth adherence intervention platform designed for individuals with Serious Mental Illness living in the community. It is currently being used to dispense medication and monitor consumer adherence. It is a fully supported digital hub that is always on network connection and provides a cost- effective mechanism for increased care coordination through the Electronic Medication Record (EMR). The enhanced intervention will add collection of health data though Bluetooth connected devices, Telehealth medical visits and integrated algorithms that provide feed back to providers and consumers about health status. | Other | Existing Medherent, New Medherent |
Primary outcome
Health Service Utilization
Time frame: Two years prior to study enrollment to at least one year after study enrollment.
The study team will use medical records and claims data to calculate monthly counts of outpatient/ambulatory care events, inpatient hospitalization, and Emergency Room or urgent care visits. The Healthcare Effectiveness Data and Information Set (HEDIS) tool will be used to identify preventable hospitalization or emergency room visits, follow up care after hospitalizations or emergency room visits.
Consumer Satisfaction STAR-P
Time frame: Change from Baseline to 6 months to 12 Months
Consumers self reports of services satisfaction with agency services. Scale is between 12 and 60. Higher scores are associated with higher satisfaction with services.
Diabetes control as reported hemoglobin A1c levels
Time frame: Two years prior to study enrollment to at least one year after study enrollment.
Reported hemoglobin A1c will be use to assess adherence to medication by modeling individual change change over time. A1C levels between 5.7 and less than 6.5% will be conferred as prediabetes range. A1C level of 6.5% or higher are considered in the diabetes range.
Reported Low-density lipoprotein (LDL)/High-density lipoprotein (HDL)
Time frame: Two years prior to study enrollment to at least one year after study enrollment.
Reported Low-density lipoprotein (LDL)/High-density lipoprotein (HDL) will be use to assess adherence to medication by modeling individual change change over time. Normal HDL is 45 to 70 mg/dL for men and 50 to 90 mg/dL for women. The cutoff for good total cholesterol to HDL ratio is 5:1. Lower ratios are better than higher ratios.
High blood pressure.
Time frame: Two years prior to study enrollment to at least one year after study enrollment.
Reported blood pressure will be use to assess adherence to medication by modeling individual change change over time. Scores will be considered normal if systolic is less than 120 mm Hg and diastolic less than 80 mm Hg. Scores will be considered elevated if systolic is 120-129 mm Hg and diastolic is less than 80 mm Hg. Scores will be considered evidence of hypertension if systolic is greater than 130 mm Hg and diastolic is more than 80 mm Hg.
Change in Health Service Costs
Time frame: Two years prior to study enrollment to at least one year after study enrollment.
Costs of health services and mental health agency care will be calculated from Medicaid Claims data. These costs will be calculated for outpatient care, emergency room/urgent care, and inpatient hospitalization care by summing up all the costs of medical claims in each of these categories by month.
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 20 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Mental Disorders, Severe
RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
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. This study is not recruiting at the moment.
George Unick principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medherent in people with Mental Disorders, Severe, run by University of Maryland, Baltimore at 1 site 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 7 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Service Utilization (time frame: Two years prior to study enrollment to at least one year after study enrollment.). The study lists 6 primary outcomes in all. 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 20 Feb 2026.