HypertensionLINKED-HEARTSNCT05321368
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
A study testing LINKED-HEARTS Program in people with Hypertension and High Blood Pressure, run by Johns Hopkins University at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, High Blood Pressure, Diabetes
- What is being tested?
- LINKED-HEARTS Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Oct 2023to 22 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age as of date of data extraction,
- Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
- 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.
- Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
- Receives primary medical care at one of the participating health systems
- Have a Maryland and D.C. home address
Who cannot join
- Age <18 years
- Diagnosis of end-stage renal disease (ESRD) treated with dialysis
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
- Cognitive impairment or other condition preventing participation in the intervention
- Planning to leave the practice or move out of the geographic area in 24 months
- No longer consider the practice site their location for primary care
- Unwillingness to provide informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Community Physicians
Baltimore, Maryland, 21205
Choptank Community Health Systems
Denton, Maryland, 21629
Unity Health Care
Washington D.C., District of Columbia, 20019
About this study
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.
- Conditions
- Hypertension, High Blood Pressure, Diabetes, Chronic Kidney Diseases
- Being tested
- LINKED-HEARTS Program
- Medical subject headings
- Hypertension, Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINKED-HEARTS ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LINKED-HEARTS Program | Experimental | 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. Receives: Behavioral: LINKED-HEARTS Program |
| Enhanced Usual Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure
Percent of patients with controlled Blood Pressure (<140/90 mm Hg).
Measured: 12 months
Secondary outcomes (7)
Change in Systolic Blood Pressure
Change from baseline in mean systolic blood pressure in millimeters of mercury (mmHg).
Measured: Baseline and 12 months
Change in Diastolic blood pressure
Change from baseline in diastolic blood pressure in mmHg.
Measured: Baseline and 12 months
Mean change in Hemoglobin A1c
Mean change from baseline in hemoglobin A1c (percent) in patients with a diagnosis of diabetes.
Measured: Baseline and 12 months
Percent with Hemoglobin A1c < 7.0
Change from baseline in the percent with hemoglobin A1c < 7.0 in patients with a diagnosis of diabetes.
Measured: Baseline and 12 months
Change in Body Mass Index (BMI)
Change from baseline in BMI (Kg/m^2).
Measured: Baseline and 12 months
Mean change in Estimated Glomerular Filtration Rate
Mean change from baseline in Estimated Glomerular Filtration Rate.
Measured: Baseline and 12 months
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
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start16 Oct 2023
- Primary completion30 Sep 2026
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Yvonne Commodore-Mensah, PhD, MSH, RN, Principal investigator, JHU School Of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321368
- Sponsor's protocol ID
- IRB00311760
- Other IDs
- P50MD017348
- Acronym
- LINKED-HEARTS
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Commodore-Mensah Y, Chen Y, Ogungbe O, Liu X, Metlock FE, Carson KA, Echouffo-Tcheugui JB, Ibe C, Crews D, Cooper LA, Himmelfarb CD. Design and rationale of the cardiometabolic health program linked with community health workers and mobile health telemonitoring to reduce health disparities (LINKED-HEARTS) program. Am Heart J. 2024 Sep;275:9-20. doi: 10.1016/j.ahj.2024.05.008. Epub 2024 May 15.
PubMed 38759910
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
- ClinicalTrials.gov ID
- NCT05321368
- Acronym / sponsor ID
- LINKED-HEARTS / IRB00311760
- Conditions
- Hypertension, High Blood Pressure, Diabetes, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LINKED-HEARTS Program | Experimental | Behavioral: LINKED-HEARTS ProgramPatients 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. |
| Enhanced Usual Care | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age as of date of data extraction,
- Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
- 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.
- Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
- Receives primary medical care at one of the participating health systems
Key exclusion criteria (7 listed)
- Age <18 years
- Diagnosis of end-stage renal disease (ESRD) treated with dialysis
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
- Cognitive impairment or other condition preventing participation in the intervention
- Planning to leave the practice or move out of the geographic area in 24 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LINKED-HEARTS ProgramThe 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. | Behavioural | LINKED-HEARTS Program |
Primary outcome
Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure
Time frame: 12 months
Percent of patients with controlled Blood Pressure (<140/90 mm Hg).
7 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Baseline and 12 months
Change in Diastolic blood pressure
Time frame: Baseline and 12 months
Mean change in Hemoglobin A1c
Time frame: Baseline and 12 months
Percent with Hemoglobin A1c < 7.0
Time frame: Baseline and 12 months
Change in Body Mass Index (BMI)
Time frame: Baseline and 12 months
Mean change in Estimated Glomerular Filtration Rate
Time frame: Baseline and 12 months
Change in Health-Related Quality of Life as assessed by the PROMIS 29
Time frame: 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 38759910Commodore-Mensah Y, Chen Y, Ogungbe O, Liu X, Metlock FE, Carson KA, Echouffo-Tcheugui JB, Ibe C, Crews D, Cooper LA, Himmelfarb CD. Design and rationale of the cardiometabolic health program linked with community health workers and mobile health telemonitoring to reduce health disparities (LINKED-HEARTS) program. Am Heart J. 2024 Sep;275:9-20. doi: 10.1016/j.ahj.2024.05.008. Epub 2024 May 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Commodore-Mensah, PhD, MSH, RN principal investigator
JHU School Of Nursing
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINKED-HEARTS Program in people with Hypertension and High Blood Pressure, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.