LINKED-HEARTS Program for Cardiometabolic Disorders
(LINKED-HEARTS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byYvonne Commodore-Mensah, PhD, MSH, RN
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: End-stage renal disease, Cancer, Cognitive impairment, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the LINKED-HEARTS Program treatment for cardiometabolic disorders?
The LINKED-HEARTS Program treatment, which combines mobile health monitoring and community support, is similar to the LINKED-BP Program that showed improvements in blood pressure among underserved populations. Additionally, telemedicine interventions have been effective in managing diabetes and reducing cardiovascular risk factors in diverse, underserved groups, suggesting potential benefits for cardiometabolic health.
12345Is the LINKED-HEARTS Program for Cardiometabolic Disorders safe for humans?
The available research does not provide specific safety data for the LINKED-HEARTS Program or its related interventions. However, it discusses the importance of addressing social and medical factors to improve cardiometabolic health, suggesting that interventions are generally focused on improving health outcomes rather than posing safety risks.
678910What makes the LINKED-HEARTS Program treatment unique 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 lifestyle changes and community involvement to improve cardiometabolic health, unlike traditional treatments that may not integrate these elements.
711121314Eligibility Criteria
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.
I am 18 years old or older.
Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic
+3 more
Exclusion Criteria
I am on dialysis for end-stage kidney disease.
I do not have any mental conditions that prevent me from participating.
Planning to leave the practice or move out of the geographic area in 24 months
+5 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: LINKED-HEARTS ProgramExperimental Treatment1 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 CareActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Choptank Community Health SystemsDenton, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. [2023]Disparities in hypertension outcomes persist among Black and Hispanic adults and persons living in poverty in the United States. The "LINKED-BP Program" is a multi-level intervention linking home blood pressure (BP) monitoring with a mobile health application, support from community health workers (CHWs), and BP measurement training at primary care practices to improve BP. This study is part of the American Heart Association RESTORE (AddREssing Social Determinants TO pRevent hypErtension) Network. This study aims to examine the effect of the LINKED-BP Program on BP reduction and to evaluate the reach, adoption, sustainability, and cost-effectiveness of the intervention.
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. [2022]CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care. OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older, ethnically diverse, medically underserved patients with diabetes. DESIGN, Setting, and Patients A randomized controlled trial was conducted, comparing telemedicine case management to usual care, with blinded outcome evaluation, in 1,665 Medicare recipients with diabetes, aged >/= 55 years, residing in federally designated medically underserved areas of New York State. Interventions Home telemedicine unit with nurse case management versus usual care. Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c (HgbA1c), low density lipoprotein (LDL) cholesterol, and blood pressure levels. RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints (HgbA1c, p = 0.001; LDL, p
Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients. [2006]Few data exist on the effectiveness of cardiovascular disease (CVD) risk-reduction programs in patients with limited access to health care. The objective of this project was to evaluate a disease management approach to multifactor CVD risk reduction in patients with limited or no health insurance and low family income. Patients (n = 148) were recruited from not-for-profit or free clinics and hospitals and randomized to usual care or usual care plus team case management. Mean age was 59.3 years, 57% were women, 50% had less than a high school education, 57% were Hispanic, and 64% had no health insurance. All had > or =1 increased risk factor for CVD, and 24.5% had documented coronary artery disease. Follow-up measurements were obtained at 6 and 12 months. Primary outcomes were low-density lipoprotein cholesterol and systolic blood pressure. The disease management program was supervised by a physician, delivered by nurses and dietitians, and included comprehensive lifestyle changes and medications. Data were collected on 91% of patients at 12 months. Disease management produced clinically important decreases in selected risk factors compared with usual care, including systolic blood pressure (p
Community-Clinical Linkages: The Effects of the Healthy Here Wellness Referral Center on Chronic Disease Indicators Among Underserved Populations in New Mexico. [2022]The majority of U.S. adults are living with at least one chronic condition, and people of color bear a disproportionate burden of chronic disease. Prior research identifies community-clinical linkages (CCLs) as a strategy for improving health. CCLs traditionally use health care providers to connect patients to community-based self-management programs. The purpose of this study was to examine the effectiveness of a centralized CCL system on health indicators and health disparities. Administrative health data were merged with referral system data to conduct a quasi-experimental comparative time series study with a comparison group of nonreferred patients. Interrupted time-series comparisons within referred patients were also conducted. Of the 2,920 patients meeting inclusion criteria, 972 (33.3%) received a referral during the study period (January 2019-September 2021). Hemoglobin A1c levels, used to diagnose diabetes, declined significantly among referred patients, as did disparities among Hispanic/Latinx participants compared with non-Hispanic White participants. No changes were observed in body mass index (BMI). Blood pressure increased among both referred and nonreferred patients. CCLs with a centralized referral system can effectively reduce markers of diabetes and may contribute to the maintenance of BMI. The observed increase in blood pressure may have been affected by the COVID-19 pandemic and warrants further study. Practitioners can work with community partners to implement a centralized CCL model, either on its own or to enhance existing clinician or community health worker-based models.
Racial and Ethnic Disparities in Diabetes Care and Impact of Vendor-Based Disease Management Programs. [2022]We examined the existence of disparities in receipt of appropriate diabetes care among California's fee-for-service Medicaid beneficiaries and the effectiveness of a telephonic-based disease management program delivered by a disease management vendor on the reduction of racial/ethnic disparities in diabetes care.
Social and Medical Determinants of Cardiometabolic Health: The Big Picture. [2022]Cardiometabolic diseases, including diabetes and heart disease, account for >12 million years of life lost annually among Black adults in the United States. Health disparities are geographically localized, with ~80% of health disparities occurring within ~6000 (16%) of all 38,000 US ZIP codes. Socio-economic status (SES), behavioral and environmental factors (social determinants) account for ~80% of variance in health outcomes and cluster geographically. Neighborhood SES is inversely associated with prevalent diabetes and hypertension, and Blacks are four times more likely than Whites to live in lowest SES neighborhoods. In ZIP code 48235 (Detroit, 97% Black, 16.2% unemployed, income/capita $18,343, 23.6% poverty), 1082 Medicare fee-for service (FFS) beneficiaries received care for type 2 diabetes (T2D) and coronary artery disease (CAD) in 2012. Collectively, these beneficiaries had 1082 inpatient admissions and 839 emergency department visits, mean cost $27,759/beneficiary and mortality 2.7%. Nationally in 2011, 236,222 Black Medicare FFS beneficiaries had 213,715 inpatient admissions, 191,346 emergency department visits, mean cost $25,580/beneficiary and 2.4% mortality. In addition to more prevalent hypertension and T2D, Blacks appear more susceptible to clinical complications of risk factors than Whites, including hypertension as a contributor to stroke. Cardiometabolic health equity in African Americans requires interventions on social determinants to reduce excess risk prevalence of risk factors. Social-medical interventions to promote timely access to, delivery of and adherence with evidence-based medicine are needed to counterbalance greater disease susceptibility. Place-based interventions on social and medical determinants of health could reduce the burden of life lost to cardiometabolic diseases in Blacks.
The Heart of New Ulm Project: using community-based cardiometabolic risk factor screenings in a rural population health improvement initiative. [2017]Awareness of cardiovascular disease and diabetes risk factors can improve the health of individuals and populations. Community-based risk factor screening programs may be particularly useful for quantifying the burden of cardiometabolic risk in a given population, particularly in underserved areas. This study provided a description of a screening platform and how it has been used to monitor the cardiometabolic risk profile within the broader Heart of New Ulm Project, which is based in a rural Minnesota community. A cross-sectional, descriptive examination of baseline screening data indicated that 45% of the target population participated in the program over 8 months. Overall, 13% of the sample reported a personal history of diabetes or cardiovascular disease. Among the subset without active cardiometabolic disease, 35% were found to be at high risk for developing cardiovascular disease or type 2 diabetes over the next 8-10 years. A high prevalence of metabolic syndrome, high low-density lipoprotein cholesterol, obesity, and low fruit/vegetable consumption were of particular concern in this community. This article describes the use of screening results to inform the design of intervention programs that target these risk factors at both the community and individual levels. In addition, design considerations for future community-based cardiometabolic risk factor screening programs are discussed, with a focus on balancing program objectives related to health surveillance, research, and the delivery of preventive health care services.
Cardiovascular health disparities: a systematic review of health care interventions. [2022]Racial and ethnic disparities in cardiovascular health care are well documented. Promising approaches to disparity reduction are increasingly described in literature published since 1995, but reports are fragmented by risk, condition, population, and setting. The authors conducted a systematic review of clinically oriented studies in communities of color that addressed hypertension, hyperlipidemia, physical inactivity, tobacco, and two major cardiovascular conditions, coronary artery disease and heart failure. Virtually no literature specifically addressed disparity reduction. The greatest focus has been African American populations, with relatively little work in Hispanic, Asian, and Native American populations. The authors found 62 interventions, 27 addressing hypertension, 9 lipids, 18 tobacco use, 8 physical inactivity, and 7 heart failure. Only 1 study specifically addressed postmyocardial infarction care. Data supporting the value of registries, multidisciplinary teams, and community outreach were found across several conditions. Interventions addressing care transitions, using telephonic outreach, and promoting medication access and adherence merit further exploration.
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. [2023]This is the first study to investigate the relationship between neighborhood walkability and cardiovascular (CV) risk factors in the United States using a large population-based database. Cross-sectional study using data from 1.1 million patients over the age of 18 in the Houston Methodist Learning Health System Outpatient Registry (2016-2022). Using the 2019 WalkScore, patients were assigned to one of the 4 neighborhood walkability categories. The burden of CV risk factors (hypertension, diabetes, obesity, dyslipidemia, and smoking) was defined as poor, average, or optimal (>3, 1-2, 0 risk factors, respectively). We included 887,654 patients, of which 86% resided in the two least walkable neighborhoods. The prevalence of CV risk factors was significantly lower among participants in the most walkable neighborhoods irrespective of ASCVD status. After adjusting for age, sex, race/ethnicity, and socioeconomic factors, we found that adults living in the most walkable neighborhoods were more likely to have optimal CV risk profile than those in the least walkable ones (RRR 2.77, 95% CI 2.64-2.91). We observed an inverse association between neighborhood walkability and the burden of CV risk factors. These findings support multilevel health system stakeholder engagements and investments in walkable neighborhoods as a viable tool for mitigating the growing burden of modifiable CV risk factors.
Cardiorenal metabolic syndrome and cardiometabolic risks in minority populations. [2021]Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the USA, regardless of self-determined race/ethnicity, and largely driven by cardiometabolic risk (CMR) and cardiorenal metabolic syndrome (CRS). The primary drivers of increased CMR include obesity, hypertension, insulin resistance, hyperglycemia, dyslipidemia, chronic kidney disease as well as associated adverse behaviors of physical inactivity, smoking, and unhealthy eating habits. Given the importance of CRS for public health, multiple stakeholders, including the National Minority Quality Forum (the Forum), the American Association of Clinical Endocrinologists (AACE), the American College of Cardiology (ACC), and the Association of Black Cardiologists (ABC), have developed this review to inform clinicians and other health professionals of the unique aspects of CMR in racial/ethnic minorities and of potential means to improve CMR factor control, to reduce CRS and CVD in diverse populations, and to provide more effective, coordinated care. This paper highlights CRS and CMR as sources of significant morbidity and mortality (particularly in racial/ethnic minorities), associated health-care costs, and an evolving index tool for cardiometabolic disease to determine geographical and environmental factors. Finally, this work provides a few examples of interventions potentially successful at reducing disparities in cardiometabolic health.
Cardiometabolic risk: New chronic care models. [2022]Cardiometabolic risk factors, and the chronic cardiovascular diseases (CVDs) that result from them, are highly prevalent in the US and amenable to clinical nutrition interventions. This creates an urgency to develop comprehensive care models that incorporate prevention-based actions by improving lifestyle routines. Such care models should account for social determinants of health, ethnocultural variables, and challenges to sustainability. The relevance of these newly designed chronic care models is to inform and facilitate early intervention, primarily consisting of lifestyle changes and healthy nutrition, which mitigates progression from one stage to subsequent, higher morbidity stages to a greater extent than late intervention. In this article, the mechanistic drivers and ethnocultural validation of the Cardiometabolic-Based Chronic Disease (CMBCD) model are reviewed. Main findings are that in CMBCD, primary (genetics, environment, and behavior) and metabolic (obesity as Adiposity-Based Chronic Disease [ABCD], type 2 diabetes as Dysglycemia-Based Chronic Disease [DBCD], hypertension, and dyslipidemia) drivers initiate and perpetuate the progression of CVD. Epidemiological findings and molecular mechanisms support intra-ABCD/DBCD, as well as ABCD to DBCD stage progression culminating in CVD. The ABCD definition overcomes weight stigma and body mass index underperformance by considering adiposity amount, distribution, and function; and the DBCD definition overcomes criticisms of prediabetes and an exclusive glucocentric approach by considering insulin resistance and residual vascular risk along a clinical spectrum. In conclusion, clinicians should approach patients using the CMBCD model to incorporate lifestyle changes as early as possible to optimally mitigate the burden of CVD.
Cultural primer for cardiometabolic health: health disparities, structural factors, community, pathways to improvement, and clinical applications. [2021]The quest to optimize cardiometabolic health has created great interest in nonmedical health variables in the population, community-based research and coordination, and addressing social, ethnic, and cultural barriers. All of these may be of equal or even greater importance than classical health care delivery in achieving individual well-being. One dominant issue is health disparity - causes, methods of reduction, and community versus other levels of solutions. This communication summarizes some major views regarding social structures, followed by amplification and synthesis of central ideas in the literature. The role of community involvement, tools, and partnerships is also presented in this Primer. Recent views of how these approaches could be incorporated into cardiometabolic initiatives and strategies follow, with implications for research. Two examples comparing selected aspects of community leverage and interventions in relation to individual approaches to health care equity are examined in depth: overall performance in reducing cardiovascular risk and mortality, and the recent National Diabetes Prevention Program, both touching upon healthy diets and adherence. Finally, the potential that precision medicine offers, and possible effects on disparities are also discussed.
Addressing cardiovascular disparities through community interventions. [2022]To identify the components and impact of intervention programs aimed at reducing cardiovascular disparities.
Community-wide prevention strategies: evaluation design of the Minnesota Heart Health Program. [2019]The Minnesota Heart Health Program (MHHP) is a community-based research and demonstration program designed to accelerate population-wide changes in coronary risk factors and disease. MHHP is on-going in three pairs of communities in Minnesota, North and South Dakota. To strengthen inference of program effects, its basic design involves elements of control, repetition, sensitive trend measurements and evaluation of the effects of program components. Its evaluation design is presented here as a comprehensive measurement system for disease endpoints, risk factor levels and efficacy of specific educational programs. The MHHP design is able to compare risk factor levels and mortality rates between education and comparison communities. MHHP statistical power is sufficient to detect community-wide changes of public health import. Early results show comparability of education and comparison communities for most variables. Widespread community awareness of and participation in MHHP programs is reported.