Clinical trial NCT05160701: Bringing Health Home
Official title: Bringing Health Home: Evaluation of a Residential-based Telehealth Care Coordination Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Disorders, Severe
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Health Service Utilization
timeFrame: Two years prior to study enrollment to at least one year after study enrollment.
measure: Consumer Satisfaction STAR-P
timeFrame: Change from Baseline to 6 months to 12 Months
measure: Diabetes control as reported hemoglobin A1c levels
timeFrame: Two years prior to study enrollment to at least one year after study enrollment.
measure: Reported Low-density lipoprotein (LDL)/High-density lipoprotein (HDL)
timeFrame: Two years prior to study enrollment to at least one year after study enrollment.
measure: High blood pressure.
timeFrame: Two years prior to study enrollment to at least one year after study enrollment.
measure: Change in Health Service Costs
timeFrame: Two years prior to study enrollment to at least one year after study enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: George Unick
role: PRINCIPAL_INVESTIGATOR
References: