Tailoring TM-HTN Intervention for Black Patients

NCT06593119 | Not Yet Recruiting

• 2 other identifiers: IRB0011628111773
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Telemedicine; socially disadvantaged; African American or Black patients

Outcome Measures

Primary Outcomes (7)

• Proportion of patients who are screened

  Proportion of patients who are screened

  Month 6

• Proportion of patients who are eligible

  Proportion of patients who are eligible

  Month 6

• Proportion of patients who agree to participate

  Proportion of patients who agree to participate

  Month 6

• Proportion of patients who decline

  Proportion of patients who decline

  Month 6

• Number of staff needed and time spent for intervention

  staff training, technical support, troubleshooting

  Month 6

• Proportion of completed self-measurement of Blood Pressure at home

  Proportion of completed self-measurement of BP at home

  Month 6

• Proportion of completed self-management contacts.

  Proportion of completed self-management contacts.

  Month 6

Secondary Outcomes (7)

• Change in Blood Pressure

  Month 6

• Medication adherence

  Month 6

• Feasibility of Intervention Measure [FIM]

  Month 6

• Acceptability of Intervention Measure [AIM]

  Month 6

• Intervention Appropriateness Measure [IAM]

  Month 6

Other Outcomes (4)

• Number of clinic, urgent care and emergency department visits

  Month 6

• Patient self-reported home BP monitor use

  Month 6

• Reasons for patient contact

  Month 6

Study Arms (2)

Telemedicine management of Hypertension intervention group

EXPERIMENTAL

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

Behavioral: Telemedicine management of Hypertension

control group

PLACEBO COMPARATOR

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.

Behavioral: Usual Care

Interventions

Telemedicine management of Hypertension 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

Also known as: TM-HTN

Telemedicine management of Hypertension intervention group

Usual Care 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.

Also known as: Control Group

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yashashwi Pokharel, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camelia Singletary, MPH

CONTACT

336.713.7210; crsingle@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 60 patients total (30 in the TM-HTN intervention group, 30 in the control group).

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)