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NCT Number: NCT06527794

Remote Hypertension Management for 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.

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Key information

Conditions

Uncontrolled Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Asha Ganesan

CONTACT

[email protected]

Yhenneko Taylor, PhD

CONTACT

[email protected]

704-355-6562

Yhenneko Taylor, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

RHYTHM (Remote Hypertension Tracking Help Management)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Baseline

    Time frame: Baseline

    Percent of patients achieving BP control (i.e., SBP<130mmHg)

  2. Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6

    Time frame: Month 6

    Percent of patients achieving BP control (i.e., SBP<130mmHg)

  3. Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18

    Time frame: Month 18

    Percent of patients achieving BP control (i.e., SBP<130mmHg)

  4. Systolic blood pressure (mmHg) - Baseline

    Time frame: Baseline

    Mean SBP (mmHg)

  5. Systolic blood pressure (mmHg) - Month 6

    Time frame: Month 6

    Mean SBP (mmHg)

  6. Systolic blood pressure (mmHg) - Month 12

    Time frame: Month 12

    Mean SBP (mmHg)

  7. Systolic blood pressure (mmHg) - Month 18

    Time frame: Month 18

    Mean SBP (mmHg)

  8. Self-Management - Hypertension Self-Care Profile Score - Baseline

    Time frame: 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.

  9. Self-Management - Hypertension Self-Care Profile Score - Month 12

    Time frame: 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.

  10. Medication adherence - Hill-Bone medication adherence scale survey score - Baseline

    Time frame: 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.

  11. Medication adherence - Hill-Bone medication adherence scale survey score - Month 12

    Time frame: 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.

  12. Patient assessment of chronic illness care (PACIC) survey score - Baseline

    Time frame: 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.

  13. Patient assessment of chronic illness care (PACIC) survey score - Month 12

    Time frame: 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.

  14. 20-Item Short Form Health Survey (SF-20) - Baseline

    Time frame: 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

  15. 20-Item Short Form Health Survey (SF-20) - Month 12

    Time frame: 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

  16. Healthcare Utilization - Number of Acute Care Days - Baseline

    Time frame: Baseline

    Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.

  17. Healthcare Utilization - Number of Acute Care Days - Month 12

    Time frame: Month 12

    Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.

  18. Healthcare Utilization - Number of Acute Care Days - Month 24

    Time frame: Month 24

    Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.

Other outcomes

  1. Therapeutic intensification Score

    Time frame: Month 12

    The therapeutic intensity score is a number that reflects the number of medications and the percent of maximal dose of each medication. Numeric range 0-5.

Study contacts

Contact information is provided by the study sponsor or research team.

Asha Ganesan

CONTACT

[email protected]

Yhenneko J. Taylor, PhD

CONTACT

[email protected]

(704) 355-6562

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Remote Hypertension Tracking, Help, and Management to Reduce Disparities in Black Patients

Acronym: RHYTHM-B

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 30, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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