## Protocol Section
### Identification Module
**NCT ID:** NCT06424730

**Brief Title:** Team Based Equity Conscious Telemedicine Approach to Hypertension

**Official Title:** Team Based Equity Conscious Telemedicine Approach to Improve Hypertension Among Black Patients

#### Organization Study ID Info
**ID:** IRB00113617
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-04

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Hypertension

**Keywords:**

- high blood pressure

- telemedicine

- African-American

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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).

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 84

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Black patients or their family members; Black community faith leaders; primary care providers and research coordinators

**Intervention Names:**

- Other: Feasibility Interview

**Label:** Interview Group

**Type:** OTHER

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Behavioral: Team Based Equity Conscious Telemedicine Hypertension Intervention

**Label:** Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Behavioral: Usual Care

**Label:** Usual Care

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interview Group

**Description:** One audio-recorded interview with the participants lasting about 30-minutes

**Name:** Feasibility Interview

**Other Names:**

- One audio-recorded interview

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention

**Description:** 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.

**Name:** Team Based Equity Conscious Telemedicine Hypertension Intervention

**Other Names:**

- Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Usual Care

**Description:** 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.

**Name:** Usual Care

**Other Names:**

- Standard of Care

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Number of clinic, urgent care and emergency department visits

**Measure:** Number of Emergency Department and Urgent Care Visits

**Time Frame:** Month 6

**Description:** Patient self-reported home BP monitor use

**Measure:** Number of Subjects using Blood Pressure Monitors

**Time Frame:** Month 6

#### Primary Outcomes

**Description:** 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

**Measure:** Barriers / Facilitators for Recruitment

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Feasibility of Telemedicine Approach - Proportion of Subjects

**Time Frame:** Month 6

#### Secondary Outcomes

**Description:** Changes in Systolic and Diastolic Blood Pressure

**Measure:** Change in Blood Pressure

**Time Frame:** Month 6

**Description:** Medication adherence using the Proportion of Days Covered

**Measure:** Percentage of Medication adherence

**Time Frame:** Month 6

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* African American or Black
* Patients with last clinic systolic Blood Pressure \>140 mmHg or diastolic Blood Pressure \>90 mmHg or both

Exclusion Criteria:

* Unable to read or speak English
* diminished ability to measure home BP (dementia, or psychosis)
* acute health changes in past 3 months increasing chance of BP instability (hospitalization);
* terminal illness.

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** schhetri@wakehealth.edu

**Name:** Sunit Chhetri

**Phone:** 336-716-9309

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Winston-Salem

**Contacts:**

***Contact 1:***

- **Email:** schhetri@wakehealth.edu

- **Name:** Sunet Chhetri

- **Phone:** 336-716-9309

- **Role:** CONTACT

**Country:** United States

**Facility:** Wake Forest University Health Sciences

**State:** North Carolina

**Zip:** 27157

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Yashashwi Pokharel, MD, MSCR

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
