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| ID | Type | Description | Link |
|---|---|---|---|
| BPS-2023C1-31377 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
| Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic intensification Score | 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. | Month 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yhenneko J. Taylor, PhD | Contact | (704) 355-6562 | Yhenneko.Taylor@advocatehealth.org | |
| Asha Ganesan | Contact | asha.ganesan@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Yhenneko J. Taylor, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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.
The Policy calls for maintenance of the Full Data Package for seven (7) years following acceptance by PCORI of the Final Research Report. In that time, PCORI may provide funds for the deposition of the Full Data Package to the PCORI-designated repository in circumstances where PCORI requests such deposition (e.g., due to PCORI estimate of high importance of research project findings or external research request).
Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to the PCORI-designated repository. There are no categorical restrictions on what types of individuals or entities may request to access the PCORI Awardee research data. Data requestors will be evaluated for their overall qualifications and experience (e.g., across a proposed team of specified individuals) to achieve the stated research purpose underlying the data request.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
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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 | 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. | 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. | 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 |
| 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 |
| 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 | 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 | 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 |