Uncontrolled HypertensionRHYTHM-BNCT06527794
Remote Hypertension Management for Black Patients
A study testing RHYTHM (Remote Hypertension Tracking Help Management) in people with Uncontrolled Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- RHYTHM (Remote Hypertension Tracking Help Management)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2024to Sep 2028
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black or African American race
- Hypertension diagnosis
- aged 21 to 85 years
- Uncontrolled blood pressure as defined by [a] most recent SBP ≥140 mmHg and an additional SBP≥140 mmHg within the past 12 months in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or [b] most recent SBP>160mmHg in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or [c] referral by PCP for uncontrolled hypertension with at least one documented SBP≥140 mmHg (in clinic or at home) in the past 12 months; and (v) primary care provided at a participating clinic.
- Able to speak English
- Primary care provided at a participating clinic
Who cannot join
- currently pregnant or planning to get pregnant during the study period
- residence in a long-term care facility, hospice or with a terminal illness with less than 1 year life expectancy as determined by the Primary Care Physician or study team. Stable chronic illness such as compensated cirrhosis, chronic obstructive pulmonary disease, congestive heart failure etc. will not be excluded.
- estimated Glomerular Filtration Rate (eGFR) <30 ml/min or on dialysis. Patients with a functioning kidney transplant will not be excluded.
- inability to provide informed consent or participate in study procedures. For example, conditions that limit ability to participate in phone visits or check BPs in at least one arm.
- currently participating in another BP management program.
- plan to move out of the area within the next 12 months.
- Hispanic ethnicity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asha Ganesan contact
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Yhenneko Taylor, PhD, 704-355-6562, Yhenneko.Taylor@atriumhealth.org
Asha Ganesan, asha.ganesan@advocatehealth.org
About this study
Official title: Remote Hypertension Tracking, Help, and Management to Reduce Disparities in Black Patients
This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.
Read the detailed description
This study is a pragmatic effectiveness-implementation hybrid type 2 trial with two study arms. One arm will include home BP telemonitoring supported by a pharmacist and a community health worker providing centralized self-management support. The other arm will include enhanced usual clinic-based care with a home BP monitor and routine care from providers trained on evidence-based guidelines.
- Conditions
- Uncontrolled Hypertension
- Being tested
- RHYTHM (Remote Hypertension Tracking Help Management), Enhanced usual care (UC)
- Keywords
- high blood pressure, African-American population, remote blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHYTHM (Remote Hypertension Tracking Help Management)Behavioural
Home blood pressure telemonitoring with remote medication management by a centralized multidisciplinary team led by a pharmacist; and social support, lifestyle education and connection to community resources to address social needs, provided by a community health worker who is embedded with the centralized team and is tightly connected to community resources and partners
Enhanced usual care (UC)Behavioural
All participating sites will receive training on appropriate blood pressure measurement and education on guideline-based hypertension therapy. Additionally, participants in usual care will receive a standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home.
| Study group | Role | What they receive |
|---|---|---|
| RHYTHM (Remote Hypertension Tracking Help Management) | Experimental | home blood pressure telemonitoring with remote medication management and social support, lifestyle education and connection to community resources to address social needs Receives: Behavioral: RHYTHM (Remote Hypertension Tracking Help Management) |
| Enhanced usual care (UC) | Experimental | standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home Receives: Behavioral: Enhanced usual care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12
Percent of patients achieving BP control (i.e., SBP<130mmHg)
Measured: Month 12
Secondary outcomes (18)
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline
Percent of patients achieving BP control (i.e., SBP<130mmHg)
Measured: Baseline
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6
Percent of patients achieving BP control (i.e., SBP<130mmHg)
Measured: Month 6
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18
Percent of patients achieving BP control (i.e., SBP<130mmHg)
Measured: Month 18
Systolic blood pressure (mmHg) - Baseline
Mean SBP (mmHg)
Measured: Baseline
Systolic blood pressure (mmHg) - Month 6
Mean SBP (mmHg)
Measured: Month 6
Systolic blood pressure (mmHg) - Month 12
Mean SBP (mmHg)
Measured: Month 12
Systolic blood pressure (mmHg) - Month 18
Mean SBP (mmHg)
Measured: Month 18
Self-Management - Hypertension Self-Care Profile Score - Baseline
The hypertension self-care profile score encompassed self-care behaviors crucial to control blood pressure - Includes 3 scales (Behavior, Motivation, Self-efficacy) 20 items each that can be used together or independently. The Behavior scale assesses participant's self-care behaviors on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-care behavior. The Motivation scale assesses participant's self-care motivation on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-care motivation. The Self-efficacy scale assesses participant's self-care efficacy on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-efficacy. Higher scores indicate better self care behaviors - range from 60-240.
Measured: Baseline
Self-Management - Hypertension Self-Care Profile Score - Month 12
The hypertension self-care profile score encompassed self-care behaviors crucial to control blood pressure - Includes 3 scales (Behavior, Motivation, Self-efficacy) 20 items each that can be used together or independently. The Behavior scale assesses participant's self-care behaviors on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-care behavior. The Motivation scale assesses participant's self-care motivation on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-care motivation. The Self-efficacy scale assesses participant's self-care efficacy on a 4-point Likert scale. Mean scores range from 1-4 with higher scores indicating higher levels of self-efficacy. Higher scores indicate better self care behaviors - range from 60-240.
Measured: Month 12
Medication adherence - Hill-Bone medication adherence scale survey score - Baseline
Hill-Bone medication adherence scale survey - 14-item Hill-Bone Compliance Scale uses a 4-point Likert scale. Score range from 14-56. Higher scores indicates poorer adherence.
Measured: Baseline
Medication adherence - Hill-Bone medication adherence scale survey score - Month 12
Hill-Bone medication adherence scale survey - 14-item Hill-Bone Compliance Scale uses a 4-point Likert scale. Score range from 14-56. Higher scores indicates poorer adherence.
Measured: Month 12
Patient assessment of chronic illness care (PACIC) survey score - Baseline
The Patient assessment of chronic illness care (PACIC) survey assess implementation of the chronic care model from the patient perspective. The PACIC includes five subscales addressing specific domains: (1) patient activation; (2) delivery system design/decision support; (3) goal setting/tailoring; (4) problem solving/contextual counselling; and (5) follow-up/coordination. Patients rated care received from their healthcare team (e.g., physicians, nurses, physiotherapists, occupational therapists, social workers) during the past 6-months using a 5-point Likert scale (1 = 'never' to 5 = 'always'). Total and subscale scores (i.e., summed items completed within that scale) are averaged across items.
Measured: Baseline
Patient assessment of chronic illness care (PACIC) survey score - Month 12
The Patient assessment of chronic illness care (PACIC) survey assess implementation of the chronic care model from the patient perspective. The PACIC includes five subscales addressing specific domains: (1) patient activation; (2) delivery system design/decision support; (3) goal setting/tailoring; (4) problem solving/contextual counselling; and (5) follow-up/coordination. Patients rated care received from their healthcare team (e.g., physicians, nurses, physiotherapists, occupational therapists, social workers) during the past 6-months using a 5-point Likert scale (1 = 'never' to 5 = 'always'). Total and subscale scores (i.e., summed items completed within that scale) are averaged across items.
Measured: Month 12
20-Item Short Form Health Survey (SF-20) - Baseline
The SF-36 Total/Global/Overall Score, a global measure of health-related quality of life - scores range from 0-100 with higher scores denoting better quality of life
Measured: Baseline
20-Item Short Form Health Survey (SF-20) - Month 12
The SF-36 Total/Global/Overall Score, a global measure of health-related quality of life - scores range from 0-100 with higher scores denoting better quality of life
Measured: Month 12
Healthcare Utilization - Number of Acute Care Days - Baseline
Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.
Measured: Baseline
Healthcare Utilization - Number of Acute Care Days - Month 12
Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.
Measured: Month 12
Healthcare Utilization - Number of Acute Care Days - Month 24
Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start13 Dec 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Yhenneko J. Taylor, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527794
- Sponsor's protocol ID
- IRB00112245
- Other IDs
- BPS-2023C1-31377
- Acronym
- RHYTHM-B
- Status last verified
- May 2026
- First submitted
- 25 Jul 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Patient-Centered Outcomes Research Institute (PCORI) Data Management and Data Sharing Policy, will prepare a Full Data Package (analyzable data set, full protocol, metadata, data dictionary, full statistical analysis plan and analytic code) for access by third parties. Per PCORI policy, the Full Data Package will be maintained at Atrium Health for 7 years, unless required by PCORI to be deposited in a separate repository.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Hypertension Tracking, Help, and Management to Reduce Disparities in Black Patients
- ClinicalTrials.gov ID
- NCT06527794
- Acronym / sponsor ID
- RHYTHM-B / IRB00112245
- Conditions
- Uncontrolled Hypertension
- Keywords
- high blood pressure, African-American population, remote blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Jul 2024 (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.
This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.
Detailed description
This study is a pragmatic effectiveness-implementation hybrid type 2 trial with two study arms. One arm will include home BP telemonitoring supported by a pharmacist and a community health worker providing centralized self-management support. The other arm will include enhanced usual clinic-based care with a home BP monitor and routine care from providers trained on evidence-based guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHYTHM (Remote Hypertension Tracking Help Management) | Experimental | Behavioral: RHYTHM (Remote Hypertension Tracking Help Management)home blood pressure telemonitoring with remote medication management and social support, lifestyle education and connection to community resources to address social needs |
| Enhanced usual care (UC) | Experimental | Behavioral: Enhanced usual care (UC)standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Black or African American race
- Hypertension diagnosis
- aged 21 to 85 years
- Uncontrolled blood pressure as defined by [a] most recent SBP ≥140 mmHg and an additional SBP≥140 mmHg within the past 12 months in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or [b] most recent SBP>160mmHg in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or [c] referral by PCP for uncontrolled hypertension with at least one documented SBP≥140 mmHg (in clinic or at home) in the past 12 months; and (v) primary care provided at a participating clinic.
- Able to speak English
Key exclusion criteria (7 listed)
- currently pregnant or planning to get pregnant during the study period
- residence in a long-term care facility, hospice or with a terminal illness with less than 1 year life expectancy as determined by the Primary Care Physician or study team. Stable chronic illness such as compensated cirrhosis, chronic obstructive pulmonary disease, congestive heart failure etc. will not be excluded.
- estimated Glomerular Filtration Rate (eGFR) <30 ml/min or on dialysis. Patients with a functioning kidney transplant will not be excluded.
- inability to provide informed consent or participate in study procedures. For example, conditions that limit ability to participate in phone visits or check BPs in at least one arm.
- currently participating in another BP management program.
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 |
|---|---|---|
| RHYTHM (Remote Hypertension Tracking Help Management)Home blood pressure telemonitoring with remote medication management by a centralized multidisciplinary team led by a pharmacist; and social support, lifestyle education and connection to community resources to address social needs, provided by a community health worker who is embedded with the centralized team and is tightly connected to community resources and partners | Behavioural | RHYTHM (Remote Hypertension Tracking Help Management) |
| Enhanced usual care (UC)All participating sites will receive training on appropriate blood pressure measurement and education on guideline-based hypertension therapy. Additionally, participants in usual care will receive a standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home. | Behavioural | Enhanced usual care (UC) |
Primary outcome
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12
Time frame: Month 12
Percent of patients achieving BP control (i.e., SBP<130mmHg)
18 secondary outcomes
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline
Time frame: Baseline
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6
Time frame: Month 6
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18
Time frame: Month 18
Systolic blood pressure (mmHg) - Baseline
Time frame: Baseline
Systolic blood pressure (mmHg) - Month 6
Time frame: Month 6
Systolic blood pressure (mmHg) - Month 12
Time frame: Month 12
Systolic blood pressure (mmHg) - Month 18
Time frame: Month 18
Self-Management - Hypertension Self-Care Profile Score - Baseline
Time frame: Baseline
Self-Management - Hypertension Self-Care Profile Score - Month 12
Time frame: Month 12
Medication adherence - Hill-Bone medication adherence scale survey score - Baseline
Time frame: Baseline
Medication adherence - Hill-Bone medication adherence scale survey score - Month 12
Time frame: Month 12
Patient assessment of chronic illness care (PACIC) survey score - Baseline
Time frame: Baseline
Patient assessment of chronic illness care (PACIC) survey score - Month 12
Time frame: Month 12
20-Item Short Form Health Survey (SF-20) - Baseline
Time frame: Baseline
20-Item Short Form Health Survey (SF-20) - Month 12
Time frame: Month 12
Healthcare Utilization - Number of Acute Care Days - Baseline
Time frame: Baseline
Healthcare Utilization - Number of Acute Care Days - Month 12
Time frame: Month 12
Healthcare Utilization - Number of Acute Care Days - Month 24
Time frame: Month 24
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 2 Jun 2026.
- Individual participant dataSharing planned: Yes. In accordance with Patient-Centered Outcomes Research Institute (PCORI) Data Management and Data Sharing Policy, will prepare a Full Data Package (analyzable data set, full protocol, metadata, data dictionary, full statistical analysis plan and analytic code) for access by third parties. Per PCORI policy, the Full Data Package will be maintained at Atrium Health for 7 years, unless required by PCORI to be deposited in a separate repository.
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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.
Asha Ganesan contact
Yhenneko J. Taylor, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHYTHM (Remote Hypertension Tracking Help Management) in people with Uncontrolled Hypertension, run by Wake Forest University Health Sciences at 1 site 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Yhenneko J. Taylor, PhD ((704) 355-6562, Yhenneko.Taylor@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12 (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.