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

Hypertension Clinical Trial

— LINKED-HEARTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321368
• Other study ID #: IRB00311760
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: Yvonne Commodore-Mensah, PhD, MSH
• Phone: 443-614-1519
• Email: ycommod1[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age as of date of data extraction,

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

3. 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.

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

5. Receives primary medical care at one of the participating health systems

6. Have a Maryland home address

Exclusion Criteria:

1. Age <18 years

2. Diagnosis of end-stage renal disease (ESRD) treated with dialysis

3. Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)

4. Cognitive impairment or other condition preventing participation in the intervention

5. Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff)

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

7. No longer consider the practice site their location for primary care

8. Unwillingness to provide informed consent

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes
• High Blood Pressure
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• LINKED-HEARTS Program
The intervention arm will include training on home blood pressure monitoring, Sphygmo blood pressure telemonitoring app, Community Health Worker visit for education, counseling on lifestyles modification and Pharmacist to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.

Locations

Country	Name	City	State
United States	Choptank Community Health Systems	Denton	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure	Percent of patients with controlled Blood Pressure (<140/90 mm Hg).	12 months
Secondary	Change in Systolic Blood Pressure	Change from baseline in mean systolic blood pressure in millimeters of mercury (mmHg).	Baseline and 12 months
Secondary	Change in Diastolic blood pressure	Change from baseline in diastolic blood pressure in mmHg.	Baseline and 12 months
Secondary	Mean change in Hemoglobin A1c	Mean change from baseline in hemoglobin A1c (percent) in patients with a diagnosis of diabetes.	Baseline and 12 months
Secondary	Percent with Hemoglobin A1c < 7.0	Change from baseline in the percent with hemoglobin A1c < 7.0 in patients with a diagnosis of diabetes.	Baseline and 12 months
Secondary	Change in Body Mass Index (BMI)	Change from baseline in BMI (Kg/m^2).	Baseline and 12 months
Secondary	Mean change in Estimated Glomerular Filtration Rate	Mean change from baseline in Estimated Glomerular Filtration Rate.	Baseline and 12 months
Secondary	Change in Health-Related Quality of Life as assessed by the PROMIS 29	This outcome will be measured using Patient-Reported Outcomes Measurement Information System®, (PROMIS) 29 Profile v. 2.0	12 months and 24 months