Tailoring TM-HTN Intervention for Black Patients

Wake Forest University (WFU)

Status: Begins enrollment in 5 months

Conditions: Hypertension

Treatments: Behavioral: Usual Care; Behavioral: Telemedicine management of Hypertension

Study type: Interventional

Funder types: Other

Identifiers

NCT06593119

11773 (Registry Identifier)

IRB00116281

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Telemedicine management of Hypertension intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Telemedicine management of Hypertension

control group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care