Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05160701
Status:
RECRUITING
Last Update Posted:
2023-09-18
First Post:
2021-11-19
Brief Title:
Bringing Health Home
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Bringing Health Home Evaluation of a Residential-based Telehealth Care Coordination Intervention
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BHH
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 stressWhile 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None