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closed because we were funded for another similar study
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The purpose of study is to understand the different factors (patient, societal, provider, clinic, health system) relevant in recruitment and participation of patients in Team Based Equity Conscious Telemedicine Approach to Improve Hypertension clinical trial.
Black patients suffer disproportionate hypertension (HTN) burden with worse control, resulting in HTN-related mortality rates twice those observed in non-Hispanic White patients. Contextually informed care approach is urgently needed in Black patients for HTN management. This study will evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a Team Based Equity Conscious Telemedicine Approach to Improve Hypertension (TET-HTN) clinical trial. This study will also evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interview Group | Other | Black patients or their family members; Black community faith leaders; primary care providers and research coordinators |
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| Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention | Experimental | Black patients with systolic blood pressure >140 mmHg on the last two clinic visits plus baseline systolic blood pressure >130 mmHg - deliver the TET-HTN intervention over six months |
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| Usual Care | Other | Black patients with systolic blood pressure >140 mmHg on the last two clinic visits plus baseline systolic blood pressure >130 mmHg - usual clinic based hypertension care using routinely available clinic services including community health worker/social worker. Clinicians can offer self-management support (e.g., dietician referral) or recommend a home blood pressure monitor. These activities mirror current primary care practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feasibility Interview | Other | One audio-recorded interview with the participants lasting about 30-minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Barriers / Facilitators for Recruitment | Evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a Team based Equity conscious Telemedicine (TET-HTN) clinical trial - will be reported as themes from thematic analysis of qualitative data | Day 1 |
| Feasibility of Telemedicine Approach - Proportion of Subjects | Evaluate the feasibility of Team Based Equity Conscious Telemedicine Hypertension intervention in a randomized comparison with usual clinic-based hypertension care. Feasibility will be measured using the proportion of patients screened, eligible, agree to participate and decline. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | Changes in Systolic and Diastolic Blood Pressure | Month 6 |
| Percentage of Medication adherence | Medication adherence using the Proportion of Days Covered |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Emergency Department and Urgent Care Visits | Number of clinic, urgent care and emergency department visits | Month 6 |
| Number of Subjects using Blood Pressure Monitors | Patient self-reported home BP monitor use |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yashashwi Pokharel, MD, MSCR | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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This study has two main objectives. First, to evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a TET-HTN clinical trial (Aim 1). Second objective is to evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach (Aim 2).
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| Team Based Equity Conscious Telemedicine Hypertension Intervention | Behavioral | Will provide blood pressure monitor connected to a telehealth application. Patients will be asked to measure home blood pressure once daily. Will intensify medications as needed based on blood pressure measurement. Trained nurses or pharmacists will provide 4 self-management telephone calls (up to 30 minutes per call) to patients to address hypertension knowledge, medication adherence, healthy eating, physical activity, weight management, stress management, tobacco and alcohol use, and sleep apnea (with referrals if needed). Will support needs relevant in blood pressure control using locally available resources via community health worker and social workers. |
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| Usual Care | Behavioral | Usual clinic based hypertension care using routinely available clinic services including community health worker/social worker. Clinicians can offer self-management support (e.g., dietician referral) or recommend a home blood pressure monitor. These activities mirror current primary care practice. |
|
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| Month 6 |
| Month 6 |
| D017530 | Health Care Quality, Access, and Evaluation |