Remote Hypertension Management for Black Patients
NCT Number: NCT06527794
Acronym: RHYTHM-B
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uncontrolled Hypertension
Interventions: BEHAVIORAL: RHYTHM (Remote Hypertension Tracking Help Management)|BEHAVIORAL: Enhanced usual care (UC)
Sponsor: Wake Forest University Health Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 864
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2028-09
Locations: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States

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. The other approach will include usual clinic-based care along with a home BP monitor and routine care.

Primary Outcome Measures: 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), Month 12
Secondary Outcome Measures: 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), 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), Month 18|Systolic blood pressure (mmHg) - Baseline, Mean SBP (mmHg), Baseline|Systolic blood pressure (mmHg) - Month 6, Mean SBP (mmHg), Month 6|Systolic blood pressure (mmHg) - Month 12, Mean SBP (mmHg), Month 12|Systolic blood pressure (mmHg) - Month 18, Mean SBP (mmHg), Month 18|Self-Management - Hypertension Self-Care Profile Score - Baseline, Hypertension self-care profile survey - The items for the hypertension self-care profile score encompassed self-care behaviors in the following areas which are crucial to control blood pressure: medication taking and lifestyle factors such as physical activity, low-sodium and low-fat diet, restricting alcohol consumption, non-smoking, self-monitoring of blood pressure, weight control, regular doctor visits - includes 3 scales (20 items each) that can be used together or independently: Behavior, Motivation, and Self-efficacy., Baseline|Self-Management -Hypertension Self-Care Profile Score - Month 12, Hypertension self-care profile survey - The items for the hypertension self-care profile score encompassed self-care behaviors in the following areas which are crucial to control blood pressure: medication taking and lifestyle factors such as physical activity, low-sodium and low-fat diet, restricting alcohol consumption, non-smoking, self-monitoring of blood pressure, weight control, regular doctor visits - includes 3 scales (20 items each) that can be used together or independently: Behavior, Motivation, and Self-efficacy., 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., 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., Month 12|Medication dose amount - Baseline, Antihypertensive medication dosage measured in milligrams, Baseline|Medication dose amount - Month 12, Antihypertensive medication dosage measured in milligrams, Month 12|Therapeutic intensification dose, Addition of a new hypertensive drug or increase in antihypertensive medication dose, 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., 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., Month 12|Consumer assessment and healthcare providers and systems adult survey score - Baseline, Consumer assessment and healthcare providers and systems adult survey measures patient satisfaction. It's used to assess the level and quality of care patients receive in hospitals across the country. The overall summary score is on a 5-star rating scale, with 1-star being the lowest and 5-star the highest. Summary star ratings average the hospital's ratings over the 19 main survey questions. Hospitals with 4- and 5-star ratings have the best scores from a patient perspective., Baseline|Consumer assessment and healthcare providers and systems adult survey score - Month 12, Consumer assessment and healthcare providers and systems adult survey measures patient satisfaction. It's used to assess the level and quality of care patients receive in hospitals across the country. The overall summary score is on a 5-star rating scale, with 1-star being the lowest and 5-star the highest. Summary star ratings average the hospital's ratings over the 19 main survey questions. Hospitals with 4- and 5-star ratings have the best scores from a patient perspective., 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., 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., 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., Month 24