- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160701
Bringing Health Home (BHH)
September 15, 2023 updated by: George Unick, University of Maryland, Baltimore
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: George Unick, PhD
- Phone Number: 4107063735
- Email: junick@ssw.umaryland.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 20201
- Recruiting
- University of Maryland
-
Contact:
- George Unick, PhD
- Phone Number: 410-706-3735
- Email: junick@ssw.umaryland.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• Unable to have the Medherent device in residence
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
Usual Care: no intervention elements.
|
|
Active Comparator: Existing Medherent
Group using the Medherent Device with no added intervention components.
|
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.
|
Experimental: New Medherent
Group using Medherent Device with added interventional components.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Two years prior to study enrollment to at least one year after study enrollment.
|
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.
|
Change from Baseline to 6 months to 12 Months
|
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.
|
Two years prior to study enrollment to at least one year after study enrollment.
|
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.
|
Two years prior to study enrollment to at least one year after study enrollment.
|
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.
|
Two years prior to study enrollment to at least one year after study enrollment.
|
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.
|
Two years prior to study enrollment to at least one year after study enrollment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: George Unick, University of Maryland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2022
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 19, 2021
First Submitted That Met QC Criteria
December 2, 2021
First Posted (Actual)
December 16, 2021
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 15, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00098021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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