Remote Hypertension Management for Black Patients

Not Applicable

Not yet recruiting

• Conditions: Uncontrolled Hypertension
• Interventions: Behavioral: Enhanced usual care (UC); Behavioral: RHYTHM (Remote Hypertension Tracking Help Management)

• Registration Number: NCT06527794
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

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 Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Study Start: 2025-01
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 864

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced usual care (UC)	Enhanced usual care (UC)	standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home
RHYTHM (Remote Hypertension Tracking Help Management)	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

Primary Outcome Measures

Name	Time	Method
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12	Month 12	Percent of patients achieving BP control (i.e., SBP\<130mmHg)

Secondary Outcome Measures

Name	Time	Method
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6	Month 6	Percent of patients achieving BP control (i.e., SBP\<130mmHg)
Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 18	Month 18	Percent of patients achieving BP control (i.e., SBP\<130mmHg)
Systolic blood pressure (mmHg) - Baseline	Baseline	Mean SBP (mmHg)
Systolic blood pressure (mmHg) - Month 6	Month 6	Mean SBP (mmHg)
Systolic blood pressure (mmHg) - Month 12	Month 12	Mean SBP (mmHg)
Systolic blood pressure (mmHg) - Month 18	Month 18	Mean SBP (mmHg)
Self-Management - Hypertension Self-Care Profile Score - Baseline	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.
Patient assessment of chronic illness care (PACIC) survey score - Baseline	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.
Self-Management - Hypertension Self-Care Profile Score - Month 12	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.
Medication adherence - Hill-Bone medication adherence scale survey score - Baseline	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.
Medication adherence - Hill-Bone medication adherence scale survey score - Month 12	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.
Patient assessment of chronic illness care (PACIC) survey score - Month 12	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.
20-Item Short Form Health Survey (SF-20) - Baseline	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
Healthcare Utilization - Number of Acute Care Days - Month 24	Month 24	Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.
20-Item Short Form Health Survey (SF-20) - Month 12	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
Healthcare Utilization - Number of Acute Care Days - Month 12	Month 12	Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.
Healthcare Utilization - Number of Acute Care Days - Baseline	Baseline	Total days spent in an emergency department, inpatient hospital, or observation unit; number of physician office visits.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States