LINKED-HEARTS Program for Cardiometabolic Disorders

(LINKED-HEARTS Trial)

Recruiting at 3 trial locations

Overseen By Yvonne Commodore-Mensah, PhD, MSH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: End-stage renal disease, Cancer, Cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

425 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the health of people with high blood pressure (BP) who also have type 2 diabetes or chronic kidney disease (CKD). It will test whether combining home BP monitoring with a telehealth system and support from pharmacists and community health workers, known as the LINKED-HEARTS Program, can better manage these conditions. Participants will either continue with their usual care or receive this new, enhanced support system. Eligible participants have uncontrolled high blood pressure (BP of 140/90 or higher) and either type 2 diabetes or CKD, and receive primary care in Maryland or D.C. This unphased trial offers a unique opportunity to contribute to innovative healthcare solutions.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, the study pharmacist will work with your healthcare providers to optimize your medication plan, which might involve adjustments.

What prior data suggests that the LINKED-HEARTS Program is safe for managing cardiometabolic disorders?

Research has shown that the LINKED-HEARTS Program is generally safe for participants. This program manages chronic conditions like high blood pressure, diabetes, and kidney disease by using home blood pressure monitors and a telemonitoring app. Community health workers and pharmacists support patients in managing their health.

No reports of serious side effects from the program itself have emerged so far. The main components—using the app and receiving help from health workers—are common practices used in other programs without major safety concerns. This suggests that the LINKED-HEARTS Program is well-tolerated. If major safety issues existed, similar programs likely would have identified them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LINKED-HEARTS Program because it integrates advanced technology and personalized care to manage cardiometabolic disorders, like hypertension and diabetes. Unlike standard treatments that often rely solely on medication, this program uses the Sphygmo telemonitoring app to track blood pressure in real-time, allowing healthcare providers to tailor treatments more effectively. It also emphasizes community health involvement, with Community Health Workers offering education and support, and pharmacists optimizing medication through telehealth visits. This holistic approach not only aims to enhance treatment adherence but also bridges the gap between clinical and community resources, potentially offering a more comprehensive solution to managing these chronic conditions.

What evidence suggests that the LINKED-HEARTS Program's treatments could be effective for cardiometabolic disorders?

Research has shown that the LINKED-HEARTS Program, a treatment arm in this trial, might help manage heart and metabolic health issues. This program combines home blood pressure monitoring (HBPM) with a telemonitoring app called Sphygmo. Studies have found that using technology and community support in this way can lower blood pressure and improve blood sugar levels. Community health workers and pharmacists play a crucial role in helping patients manage their health and medications. These combined efforts aim to help patients control high blood pressure, diabetes, and kidney health. Early results suggest that this approach can improve health outcomes for people with these long-term conditions. ^{2 4 6 7 8}

Who Is on the Research Team?

Yvonne Commodore-Mensah, PhD, MSH, RN

Principal Investigator

JHU School Of Nursing

Are You a Good Fit for This Trial?

Adults with uncontrolled high blood pressure and either type 2 diabetes or chronic kidney disease, who are non-Hispanic white, Black/African American, or Hispanic. They must be getting care at participating health centers in Maryland and not have plans to move soon. People with severe medical conditions like cancer or those on dialysis for end-stage renal disease cannot join.

Inclusion Criteria

I have been diagnosed with high blood pressure.

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

Receives primary medical care at one of the participating health systems

Exclusion Criteria

I am on dialysis for end-stage kidney disease.

Planning to leave the practice or move out of the geographic area in 24 months

I do not have any mental conditions that prevent me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home blood pressure monitoring and telemonitoring interventions, with support from community health workers and pharmacists to manage chronic conditions

12 months

Regular telehealth visits

Follow-up

Participants are monitored for changes in blood pressure, BMI, and other health metrics

12 months

Long-term Follow-up

Participants' health-related quality of life is assessed using PROMIS 29

24 months

What Are the Treatments Tested in This Trial?

Interventions

• LINKED-HEARTS Program

Trial Overview The LINKED-HEARTS Program tests a new way to manage high blood pressure and related conditions using home monitoring linked to a telemonitoring platform, community health workers, pharmacists' support via telehealth, and an app called Sphygmo. The goal is better control of blood pressure, sugar levels, and kidney function.

How Is the Trial Designed?

Group I: LINKED-HEARTS Program Experimental Treatment 1 Intervention

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.

Group II: Enhanced Usual Care Active Control 1 Intervention

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.

LINKED-HEARTS Program is already approved in United States for the following indications:

Approved in United States as LINKED-HEARTS Program for:

• Hypertension
• Type 2 Diabetes
• Chronic Kidney Disease

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In a rural Minnesota community, a screening program revealed that 45% of the target population participated, with 13% having a personal history of diabetes or cardiovascular disease, highlighting the importance of community engagement in health monitoring.

Among participants without existing cardiometabolic disease, 35% were identified as high risk for developing cardiovascular disease or type 2 diabetes in the next 8-10 years, indicating a significant need for targeted intervention programs to address risk factors like obesity and low fruit/vegetable consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Heart of New Ulm Project: using community-based cardiometabolic risk factor screenings in a rural population health improvement initiative. VanWormer, JJ., Johnson, PJ., Pereira, RF., et al.[2017]

Cardiovascular disease (CVD) is the leading cause of death in the USA, significantly influenced by cardiometabolic risk (CMR) factors such as obesity, hypertension, and unhealthy lifestyle choices, particularly affecting racial and ethnic minorities.

The review emphasizes the need for improved control of CMR factors and coordinated care strategies to reduce the prevalence of cardiorenal metabolic syndrome (CRS) and CVD, highlighting interventions that could help address health disparities in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorenal metabolic syndrome and cardiometabolic risks in minority populations. Ferdinand, KC., Rodriguez, F., Nasser, SA., et al.[2021]

A disease management program for cardiovascular disease (CVD) risk reduction, involving 148 patients with limited healthcare access, led to significant decreases in systolic blood pressure and low-density lipoprotein cholesterol compared to usual care.

The program, which included lifestyle changes and medication, successfully helped more patients move from high-risk to lower-risk categories for CVD, demonstrating its effectiveness in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients. Haskell, WL., Berra, K., Arias, E., et al.[2006]

A centralized community-clinical linkage (CCL) system significantly reduced hemoglobin A1c levels among 972 referred patients, indicating improved diabetes management, particularly benefiting Hispanic/Latinx participants who showed reduced health disparities compared to non-Hispanic White participants.

While the CCL system helped lower diabetes markers, it did not affect body mass index (BMI) and was associated with an increase in blood pressure, which may be linked to the COVID-19 pandemic, suggesting the need for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Clinical Linkages: The Effects of the Healthy Here Wellness Referral Center on Chronic Disease Indicators Among Underserved Populations in New Mexico. Cruz, TH., Boursaw, B., Barqawi, YK., et al.[2022]

A study involving nearly 6,000 Medicaid beneficiaries in California found significant racial/ethnic disparities in diabetes care, particularly in the receipt of essential tests like HbA1c, LDL cholesterol, and retinal examinations, with African Americans and Latinos receiving fewer tests compared to whites.

The telephonic disease management program implemented over three years did not effectively reduce these disparities in diabetes care for African Americans and Latinos, although it did show some improvement for Asian Americans and Pacific Islanders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial and Ethnic Disparities in Diabetes Care and Impact of Vendor-Based Disease Management Programs. Meng, YY., Diamant, A., Jones, J., et al.[2022]

Addressing social, ethnic, and cultural barriers is crucial for optimizing cardiometabolic health, potentially having a greater impact than traditional healthcare delivery methods.

Community involvement and partnerships are essential in reducing health disparities, as demonstrated by initiatives like the National Diabetes Prevention Program, which focuses on promoting healthy diets and improving adherence to health recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural primer for cardiometabolic health: health disparities, structural factors, community, pathways to improvement, and clinical applications. Kones, R., Rumana, U.[2021]

This study analyzed data from 887,654 patients in the Houston Methodist Learning Health System and found that those living in the most walkable neighborhoods had a significantly lower prevalence of cardiovascular (CV) risk factors compared to those in less walkable areas.

Adults in walkable neighborhoods were 2.77 times more likely to have an optimal CV risk profile, suggesting that improving neighborhood walkability could be an effective strategy for reducing modifiable CV risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Favorable Neighborhood Walkability is Associated With Lower Burden of Cardiovascular Risk Factors Among Patients Within an Integrated Health System: The Houston Methodist Learning Health System Outpatient Registry. Makram, OM., Nwana, N., Nicolas, JC., et al.[2023]

Cardiometabolic diseases, such as diabetes and heart disease, lead to significant health disparities among Black adults in the U.S., with 12 million years of life lost annually, particularly in low socio-economic neighborhoods.

Interventions targeting social determinants of health, including access to medical care and adherence to treatment, are essential to improve cardiometabolic health equity and reduce the higher prevalence of diseases and complications in Black communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social and Medical Determinants of Cardiometabolic Health: The Big Picture. Puckrein, GA., Egan, BM., Howard, G.[2022]

The Minnesota Heart Health Program (MHHP) is effectively designed to evaluate changes in coronary risk factors and disease across multiple communities, utilizing a robust evaluation system to compare outcomes between education and control groups.

Early results indicate that communities participating in MHHP show comparable risk factor levels and mortality rates, suggesting that the program is successfully engaging the community and raising awareness about heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-wide prevention strategies: evaluation design of the Minnesota Heart Health Program. Jacobs, DR., Luepker, RV., Mittelmark, MB., et al.[2019]

A systematic review identified 62 interventions aimed at reducing cardiovascular health disparities in communities of color, primarily focusing on hypertension and tobacco use, but with limited research on Hispanic, Asian, and Native American populations.

The review highlighted the effectiveness of strategies like community outreach, multidisciplinary teams, and registries in improving care, suggesting that further exploration of care transitions and medication access could enhance outcomes for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular health disparities: a systematic review of health care interventions. Davis, AM., Vinci, LM., Okwuosa, TM., et al.[2022]

The Cardiometabolic-Based Chronic Disease (CMBCD) model emphasizes the importance of early lifestyle interventions and nutrition to prevent the progression of cardiovascular diseases (CVD) from initial risk factors, highlighting that addressing these factors early can significantly reduce morbidity.

The CMBCD model integrates genetic, environmental, and behavioral factors with a focus on obesity and insulin resistance, providing a comprehensive approach that moves beyond traditional metrics like BMI to better assess and manage cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk: New chronic care models. Nieto-Martínez, R., González-Rivas, JP., Mechanick, JI.[2022]

The LINKED-BP Program, which combines home blood pressure monitoring with a mobile health app and support from community health workers, aims to reduce blood pressure in underserved populations, specifically targeting Black and Hispanic adults and those living in poverty.

This study will involve 600 adults with elevated blood pressure over 12 months, assessing the program's effectiveness in lowering systolic blood pressure and its potential to improve health equity in hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. Commodore-Mensah, Y., Liu, X., Ogungbe, O., et al.[2023]

A randomized controlled trial involving 1,665 Medicare recipients with diabetes demonstrated that telemedicine case management significantly improved key health metrics, including hemoglobin A1c, LDL cholesterol, and blood pressure over a 5-year period.

Despite the improvements in health outcomes, the study found no significant difference in mortality rates between the telemedicine and usual care groups, suggesting that while telemedicine is effective for managing diabetes, it does not impact overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. Shea, S., Weinstock, RS., Teresi, JA., et al.[2022]

Intervention programs aimed at reducing cardiovascular disparities among African Americans often focus on lifestyle changes and attitudes, but their impacts are typically short-lived due to a lack of sustainability and community support.

Most studies reviewed did not have long enough timelines to measure significant clinical outcomes, highlighting the need for more comprehensive and enduring strategies to address these disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing cardiovascular disparities through community interventions. Shaya, FT., Gu, A., Saunders, E.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11134435

RePORT RePORTER - National Institutes of Health (NIH) | We have designed the LINKED-HEARTS Program, an innovative, theoretically derived, patient-centered, multi-level intervention to address individual and community ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002870324001236

Design and rationale of the cardiometabolic health ... Participants in the LINKED-HEARTS intervention arm receive training on HBPM, BP and glucose telemonitoring, and community health worker and pharmacist ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05321368/a-cardiometabolic-health-program-linked-with-clinical-community-support-and-mobile-health-telemonitoring-to-reduce-health-disparities

A Cardiometabolic Health Program Linked With Clinical ... The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) ...

4. withpower.com withpower.com/trial/phase-chronic-kidney-disease-ckd-5-2022-f2d98

LINKED-HEARTS Program for Cardiometabolic Disorders The LINKED-HEARTS Program is unique because it combines clinical-community support with mobile health telemonitoring to address health disparities, focusing on ...

5. researchgate.net researchgate.net/publication/380694151_Design_and_Rationale_of_the_Cardiometabolic_Health_Program_Linked_with_Community_Health_Workers_and_Mobile_Health_Telemonitoring_to_Reduce_Health_DisparitieS_LINKED-HEARTS_Program

Design and Rationale of the Cardiometabolic Health ... The primary clinical outcome is change from baseline in systolic BP at 6 and 12 months. Discussions: The LINKED-BP Program tests a sustainable, scalable ...

6. reporter.nih.gov reporter.nih.gov/search/sY7_wTfcN0y3yyG_1P5umw/project-details/10897852

RePORT RePORTER - National Institutes of Health (NIH) | A Cardiometabolic Health Program LINKED with Clinical-Community Support and Mobile HEAlth TelemonitoRing in Underserved PopulaTionS (LINKED-HEARTS PROGRAM).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11748808/

Design and Rationale of the Cardiometabolic Health Program ... Thus, we developed the “Cardiometabolic Health Program LINKED with Community Health WorkErs and Mobile HeAlth TelemonitoRing To reduce Health ...

8. clinconnect.io clinconnect.io/trials/NCT05321368

A Cardiometabolic Health Program Linked With - ClinConnect The LINKED-HEARTS Program is a clinical trial designed to help adults with high blood pressure (hypertension), diabetes, and chronic kidney disease. The goal of ...