A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced usual care arm, wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the intervention arm which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age as of date of data extraction,

• Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,

• Diagnosis of Hypertension (HTN) defined by International Classification of Diseases, Tenth code (ICD-10 code) and elevated systolic blood pressure (SBP) measure (≥140 mm Hg) on their most recent clinic visit.

• Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN

• Receives primary medical care at one of the participating health systems

• Have a Maryland and D.C. home address

Locations
United States
Washington, D.c.
Unity Health Care
RECRUITING
Washington D.c.
Maryland
Johns Hopkins Community Physicians
RECRUITING
Baltimore
Choptank Community Health Systems
ACTIVE_NOT_RECRUITING
Denton
Contact Information
Primary
Yvonne Commodore-Mensah, PhD, MSH
ycommod1@jhu.edu
443-614-1519
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2027-04-22
Participants
Target number of participants: 425
Treatments
Experimental: LINKED-HEARTS Program
Patients in the LINKED-HEARTS Program will be trained to measure their blood pressure with an Omron 10 series device using the Sphygmo telemonitoring app. The physician, pharmacist and Community Health Worker will have access to transmit data.~Community Health Workers will provide education on managing blood pressure; reinforce positive blood pressure self-management behaviors; deliver knowledge and skills to promote healthy chronic conditions; assist with linking clinical and administrative services; and link participants with community resources.~The study pharmacist will conduct telehealth visits, optimize pharmacologic therapy. The pharmacists will assess and address medication adherence to improve hypertension and diabetes control.
No_intervention: Enhanced Usual Care
Patients in the Enhanced Usual Care Arm, will receive care as usual from their primary care provider and will be trained to measure their blood pressure with an Omron 10 series device. The staff in each participating community health center practice will be trained in blood pressure measurement best practices.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov