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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05321368
Other study ID # IRB00311760
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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