Tailoring TM-HTN Intervention for Black Patients

NCT ID: NCT06593119

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-31
• Study Completion Date: 2028-08-31

Brief Summary

Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control.

Detailed Description

Telemedicine management of HTN (TM-HTN) can augment and overcome challenges by allowing more support for patients' HTN self-care skills, providing multiple home Blood Pressure values and overcoming failure to appropriately intensify treatment. TM-HTN consists of 1) home BP monitoring, 2) home BP based pharmacotherapy, and 3) telemedicine-based self-management support.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telemedicine management of Hypertension intervention group

BP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training

Group Type: EXPERIMENTAL

Telemedicine management of Hypertension

Intervention Type: BEHAVIORAL

TM-HTN intervention includes tailored and frequent self-management support, home blood pressure monitoring, pharmacotherapy, and as-needed assistance for health-related social needs provided by pharmacists, nurses, community health workers, and social workers. This will be compared with usual care

control group

This includes usual clinic based Hypertension care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

This includes usual clinic based HTN care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.

Interventions

Telemedicine management of Hypertension

TM-HTN intervention includes tailored and frequent self-management support, home blood pressure monitoring, pharmacotherapy, and as-needed assistance for health-related social needs provided by pharmacists, nurses, community health workers, and social workers. This will be compared with usual care

Intervention Type: BEHAVIORAL

Usual Care

This includes usual clinic based HTN care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.

Intervention Type: BEHAVIORAL

Other Intervention Names

TM-HTN; Control Group

Eligibility Criteria

Inclusion Criteria

• Subjects must be African American or Black
• experiencing socially disadvantage
• Patients with systolic Blood Pressure ≥140 mmHg on their last two clinic visits and baseline systolic BP >130 mmHg using the mean of two research BP values measured by trained staff
• Subjects must be on stable Blood Pressure medications for the preceding 6 weeks

Exclusion Criteria

• Unable to read or speak English
• diminished ability to measure home Blood Pressure
• chronic kidney disease ≥stage 4
• persistent/chronic atrial fibrillation
• severe hypertension >180/110 mmHg
• acute health changes in past 3 months increasing chance of Blood Pressure instability
• terminal illness

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yashashwi Pokharel, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Central Contacts

Camelia Singletary, MPH

Role: CONTACT

crsingle@wakehealth.edu

336.713.7210

Facility Contacts

Camelia Singletary, MPH

Role: primary

crsingle@wakehealth.edu

336-713-7210

Other Identifiers

11773

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00116281

Identifier Type: -

Identifier Source: org_study_id