Chronic Kidney Diseases, Diabetes, High Blood Pressure, Hypertension
Conditions
Brief 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.
Interventions
BEHAVIORALLINKED-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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 and D.C. 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. Planning to leave the practice or move out of the geographic area in 24 months 6. No longer consider the practice site their location for primary care 7. Unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure | 12 months | Percent of patients with controlled Blood Pressure (\<140/90 mm Hg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diastolic blood pressure | Baseline and 12 months | Change from baseline in diastolic blood pressure in mmHg. |
| Mean change in Hemoglobin A1c | Baseline and 12 months | Mean change from baseline in hemoglobin A1c (percent) in patients with a diagnosis of diabetes. |
| Percent with Hemoglobin A1c < 7.0 | Baseline and 12 months | Change from baseline in the percent with hemoglobin A1c \< 7.0 in patients with a diagnosis of diabetes. |
| Change in Systolic Blood Pressure | Baseline and 12 months | Change from baseline in mean systolic blood pressure in millimeters of mercury (mmHg). |
| Mean change in Estimated Glomerular Filtration Rate | Baseline and 12 months | Mean change from baseline in Estimated Glomerular Filtration Rate. |
| Change in Health-Related Quality of Life as assessed by the PROMIS 29 | 12 months and 24 months | This outcome will be measured using Patient-Reported Outcomes Measurement Information System®, (PROMIS) 29 Profile v. 2.0 |
| Change in Body Mass Index (BMI) | Baseline and 12 months | Change from baseline in BMI (Kg/m\^2). |
Countries
United States
Contacts
Primary ContactYvonne Commodore-Mensah, PhD, MSH
Outcome results
None listed