HypertensionLINKED-BPNCT05180045
Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure
A study testing LINKED-BP Program in people with Hypertension and High Blood Pressure, run by Johns Hopkins University at 20 sites in United States.
Trial summary
The LINKED-BP Program is a patient-centered, multi-level intervention linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo) that links with all Bluetooth-enabled validated blood pressure (BP) devices, support from community health workers (CHWs), and BP measurement training at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, High Blood Pressure
- What is being tested?
- LINKED-BP Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 20 sitesUnited States
- Study dates
- 17 Jul 2023to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 the date of data extraction
- Self-identify as non-Hispanic white, non-Hispanic African-American or Hispanic
- Have elevated BP (120-129/<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) (defined by AHA's 2017 hypertension clinical guidelines)
- Receives primary medical care at one of the participating community health centers and primary care practices
Who cannot join
- Age <18 years
- Prescribed antihypertensive medication
- Diagnosis of end-stage renal disease (ESRD)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
- Patients with serious cognitive impairment or other conditions preventing their participation in the intervention
Show all 10Show fewer
- Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff)
- Those planning to leave the practice or move out of the geographic area in 18 months
- Those who no longer consider the practice site the location where they receive primary care
- Unwillingness to provide informed consent
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Johns Hopkins Community Physicians Remington
Baltimore, Maryland, 21211
Johns Hopkins Community Physicians Bowie
Bowie, Maryland, 20715
Johns Hopkins Community Physicians Brandywine
Brandywine, Maryland, 20613
Choptank Fassett Magee Medical and Cambridge Dental Center
Cambridge, Maryland, 21613
Choptank Denton Health Center
Denton, Maryland, 21629
Johns Hopkins Community Physicians Greater Dundalk
Dundalk, Maryland, 21222
Choptank Easton Health Center
Easton, Maryland, 21601
Choptank Federalsburg Medical and Dental Center
Federalsburg, Maryland, 21632
Johns Hopkins Community Physicians Fulton
Fulton, Maryland, 20759
Choptank Goldsboro
Goldsboro, Maryland, 21636
Johns Hopkins Community Physicians White Marsh
Nottingham, Maryland, 21236
Choptank Bay Hundred
Saint Michaels, Maryland, 21663
Johns Hopkins Community Physicians I Street
Washington D.C., District of Columbia, 20005
Unity Upper Cardozo Health Center
Washington D.C., District of Columbia, 20009
Unity Brentwood Health Center
Washington D.C., District of Columbia, 20018
Unity East of the River
Washington D.C., District of Columbia, 20019
Unity Minnesota Avenue Health Center
Washington D.C., District of Columbia, 20019
Unity Parkside Health Center
Washington D.C., District of Columbia, 20019
Unity Anacostia Health Center
Washington D.C., District of Columbia, 20020
Johns Hopkins Community Physicans Charles County-White Plains
White Plains, Maryland, 20695
About this study
The LINKED-BP Program is a patient-centered, multi-level intervention linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo) that links with all Bluetooth-enabled validated blood pressure (BP) devices, support from community health workers (CHWs), and BP measurement training at community health centers serving high-risk adults to prevent stage 2 hypertension (BP ≥ 140/90 mm Hg). The LINKED-BP Program study will recruit a total of 600 adults (30 from each practice) with elevated BP (120-129/<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) across 20 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 (HBPM) and will be managed by the patients' primary care clinicians as usual; and (2) the LINKED-BP Program or "intervention arm," which will include training of patients on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. The intervention period for each study participant is 12 months.
- Conditions
- Hypertension, High Blood Pressure
- Being tested
- LINKED-BP Program
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINKED-BP ProgramBehavioural
The intervention arm will include training on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. Patients will be trained to measure their BP in the morning and evening for 7 days. Patients enter data using Bluetooth device transmission or manual entry. Guidance is provided on accurate BP measurement. The app stores and securely relays data to the cloud. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. Other components of usual care at the practices may include dietary counseling, on-site clinical pharmacists, social workers, case managers as needed for BP follow up, and assistance with medications and appointments as needed. The intervention period for each study participant is 12 months.
| Study group | Role | What they receive |
|---|---|---|
| LINKED-BP Program | Experimental | Patients in the LINKED-BP Program will be trained to measure their BP with an Omron 10 series device. Patients who have smartphones will download the patient facing app and receive a unique link from the study team. Patients who do not own a smartphone will be provided one with a data plan for the duration of the study. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal.
CHWs will support patients by: (1) providing education on how to manage BP through self-monitoring and practicing dietary modification and exercise; (2) reinforcing positive BP self-management through follow-up encounters; (3) assisting with linkages to existing clinical and administrative services; and (4) link participants with community resources to address health-related social needs.
The staff in each participating community health center practice will be trained in blood pressure measurement best practices. Receives: Behavioral: LINKED-BP Program |
| Enhanced Usual Care | No intervention | Patients in the Enhanced Usual Care Arm, will receive care as usual from thier primary care provider and will be trained to measure their BP 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.
Change in systolic blood pressure
Change in systolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.
Measured: Baseline and 12 months
Secondary outcomes (1)
Change in diastolic blood pressure
Change in diastolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start17 Jul 2023
- Primary completion25 Jul 2026
- Study completion25 Jul 2026
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
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Yvonne Commodore-Mensah, PhD, MHS, RN, Principal investigator, JHU School Of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180045
- Sponsor's protocol ID
- IRB00307545
- Acronym
- LINKED-BP
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Commodore-Mensah Y, Liu X, Ogungbe O, Ibe C, Amihere J, Mensa M, Martin SS, Crews D, Carson KA, Cooper LA, Himmelfarb CR. Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. Am J Hypertens. 2023 Apr 15;36(5):273-282. doi: 10.1093/ajh/hpad001.
PubMed 37061796
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure
- ClinicalTrials.gov ID
- NCT05180045
- Acronym / sponsor ID
- LINKED-BP / IRB00307545
- Conditions
- Hypertension, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 25 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 6 Jan 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-BP Program is a patient-centered, multi-level intervention linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo) that links with all Bluetooth-enabled validated blood pressure (BP) devices, support from community health workers (CHWs), and BP measurement training at community health centers serving high-risk adults to prevent stage 2 hypertension (BP ≥ 140/90 mm Hg). The LINKED-BP Program study will recruit a total of 600 adults (30 from each practice) with elevated BP (120-129/<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) across 20 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 (HBPM) and will be managed by the patients' primary care clinicians as usual; and (2) the LINKED-BP Program or "intervention arm," which will include training of patients on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. The intervention period for each study participant is 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LINKED-BP Program | Experimental | Behavioral: LINKED-BP ProgramPatients in the LINKED-BP Program will be trained to measure their BP with an Omron 10 series device. Patients who have smartphones will download the patient facing app and receive a unique link from the study team. Patients who do not own a smartphone will be provided one with a data plan for the duration of the study. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. CHWs will support patients by: (1) providing education on how to manage BP through self-monitoring and practicing dietary modification and exercise; (2) reinforcing positive BP self-management through follow-up encounters; (3) assisting with linkages to existing clinical and administrative services; and (4) link participants with community resources to address health-related social needs. The staff in each participating community health center practice will be trained in blood pressure measurement best practices. |
| Enhanced Usual Care | No intervention | –Patients in the Enhanced Usual Care Arm, will receive care as usual from thier primary care provider and will be trained to measure their BP 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 (4 listed)
- 18 years of age as of the date of data extraction
- Self-identify as non-Hispanic white, non-Hispanic African-American or Hispanic
- Have elevated BP (120-129/<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) (defined by AHA's 2017 hypertension clinical guidelines)
- Receives primary medical care at one of the participating community health centers and primary care practices
Key exclusion criteria (10 listed)
- Age <18 years
- Prescribed antihypertensive medication
- Diagnosis of end-stage renal disease (ESRD)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
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-BP ProgramThe intervention arm will include training on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. Patients will be trained to measure their BP in the morning and evening for 7 days. Patients enter data using Bluetooth device transmission or manual entry. Guidance is provided on accurate BP measurement. The app stores and securely relays data to the cloud. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. Other components of usual care at the practices may include dietary counseling, on-site clinical pharmacists, social workers, case managers as needed for BP follow up, and assistance with medications and appointments as needed. The intervention period for each study participant is 12 months. | Behavioural | LINKED-BP Program |
Primary outcome
Change in systolic blood pressure
Time frame: Baseline and 12 months
Change in systolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.
1 secondary outcome
Change in diastolic blood pressure
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 37061796Commodore-Mensah Y, Liu X, Ogungbe O, Ibe C, Amihere J, Mensa M, Martin SS, Crews D, Carson KA, Cooper LA, Himmelfarb CR. Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. Am J Hypertens. 2023 Apr 15;36(5):273-282. doi: 10.1093/ajh/hpad001.
- Individual participant dataSharing planned: Undecided
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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, MHS, RN principal investigator
JHU School Of Nursing
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINKED-BP Program in people with Hypertension and High Blood Pressure, run by Johns Hopkins University at 20 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in systolic blood pressure (time frame: Baseline and 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 NCT05180045, 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 14 Aug 2026.