Clinical trial NCT05321368: A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
Official title: A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
High Blood Pressure
Diabetes
Chronic Kidney Diseases
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-04-11
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 12 months
measure: Change in Diastolic blood pressure
timeFrame: Baseline and 12 months
measure: Mean change in Hemoglobin A1c
timeFrame: Baseline and 12 months
measure: Percent with Hemoglobin A1c < 7.0
timeFrame: Baseline and 12 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 12 months
measure: Mean change in Estimated Glomerular Filtration Rate
timeFrame: Baseline and 12 months
measure: Change in Health-Related Quality of Life as assessed by the PROMIS 29
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Unity Health Care
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Community Physicians
state: Maryland
city: Denton
country: United States
facility: Choptank Community Health Systems
state: Maryland
Study officials:
affiliation: JHU School Of Nursing
name: Yvonne Commodore-Mensah, PhD, MSH, RN
role: PRINCIPAL_INVESTIGATOR
References: