Telehealth Care-Coordination for Mental Illness

(BHH Trial)

Overseen By George Unick, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Psychiatric medications

Disqualifiers: Unable to have Medherent device

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how telehealth (remote healthcare using technology) can improve health outcomes for individuals with serious mental illnesses (SMI) who also face challenges like heart disease and diabetes. It tests the Medherent device, which aids in medication management, alongside new services to determine if they enhance care for SMI patients. The study includes three groups: those receiving usual care, current Medherent users, and new users trying the expanded services. The trial seeks individuals diagnosed with SMI, already prescribed psychiatric medications, and receiving services from a community mental health agency. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions and improve care for SMI patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be prescribed psychiatric medications, it seems likely that you will continue your current medication regimen.

What prior data suggests that this telehealth care-coordination method is safe for individuals with serious mental illnesses?

Research shows that Medherent is a tool designed to help people with mental health conditions take their medications on time. Some evidence indicates it improves adherence to medication schedules, but detailed information about safety concerns is limited.

Most studies focus on the device's effectiveness in aiding medication adherence. For instance, individuals with conditions like schizophrenia or bipolar disorder often take only 50-70% of their prescribed medication, and Medherent aims to improve this rate.

Although specific safety data is lacking, Medherent's use in other trials suggests it is generally considered safe. Previous approval for similar uses also supports this view. However, discussing potential risks with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Care-Coordination for Mental Illness trial because it explores how the Medherent device can enhance care for those with mental illness. Unlike standard treatment options, which often involve medication and in-person therapy sessions, this trial investigates how a digital platform can provide consistent medication management and patient support remotely. The "New Medherent" arm introduces additional interventional components, potentially offering a more comprehensive approach by combining technology with traditional care. This could lead to better adherence, more personalized care, and ultimately, improved outcomes for patients with mental health conditions.

What evidence suggests that the Medherent telehealth care-coordination services are effective for individuals with serious mental illnesses?

Research has shown that the Medherent platform helps individuals with serious mental disorders take their medication more regularly. This improvement links to fewer emergency room visits and lower hospital costs, enabling individuals to stay healthier and live at home. One study found that Medherent users adhered better to their medication regimen, addressing a significant issue for this group. The device aids by sending digital reminders and tracking medication use, leading to improved health. In this trial, participants will be divided into groups: one will use the existing Medherent device, while another will use a new version with added interventional components. This evidence suggests that Medherent effectively helps people with serious mental illnesses manage their conditions. ^{2 3 5 6 7}

Who Is on the Research Team?

George Unick

Principal Investigator

University of Maryland

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with Serious Mental Illness (SMI) who are prescribed psychiatric medications and receive services from a participating community mental health agency. They must be willing to have the Medherent device in their residence, either as current users or new participants.

Inclusion Criteria

I am taking medication for a mental health condition.

Sample 2: Willing or able to authorize to have the Medherent device in your residence

Serious Mental Illness Diagnosis

Exclusion Criteria

Unable to have the Medherent device in residence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Medherent medication management platform and receive telehealth care-coordination services

12 months

Monthly virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Medherent

Trial Overview The study tests the Medherent medication management platform along with additional telehealth care-coordination services aimed at improving health outcomes for individuals with SMI living in community settings.

How Is the Trial Designed?

Group I: New Medherent Experimental Treatment 1 Intervention

Group using Medherent Device with added interventional components.

Group II: Usual Care Active Control 1 Intervention

Usual Care: no intervention elements.

Group III: Existing Medherent Active Control 1 Intervention

Group using the Medherent Device with no added intervention components.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11975706/

MedHerent: Improving Medication Adherence in Older Adults ... We used design thinking to create a contextually sensitive digital health mobile application to improve medication adherence in older adults.

2. altruix.com altruix.com/medherent-medication-adherence-technology/

Medication Adherence Technology Improved Health. Medherent has been show to significantly reduce ER visits and hospital costs and helps keep people healthy and in their homes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12137551/

Randomized clinical trial of a digital medication system to ... To evaluate the effectiveness of a digital medication system in improving adherence among patients with serious mental disorders (SMD), ...

4. bing.inknowvation.com bing.inknowvation.com/sbir/awards/nih-2018-assessment-medherent-medication-management-device-and-adherence-platform

NIH 2018 Assessment of Medherent Medication Management ... Unfortunately, adherence rates for individuals diagnosed with SPMI is 50- 70% of prescribed somatic and psychiatric medications, well under the 80% considered ...

5. clinicaltrial.be clinicaltrial.be/fr/details/6146?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Assessment of Medherent Medication Management Device ... Measure change in adherence by triangulating self-report data, clinician observation, biological measures, chart reviews and clinical outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10258931/

Understanding the medication safety challenges for ... Included studies reported data on epidemiology, aetiology, or interventions related to medication safety for patients with mental illness in primary care.

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06838-9

Non-adherence level of pharmacotherapy and its predictors ... The present study critically evaluates, integrates, and summarizes psychotropic medication non-adherence and its determinants among patients with mental ...