Team Based Equity Conscious Telemedicine Approach to Hypertension

Hypertension Clinical Trial

Official title:

Team Based Equity Conscious Telemedicine Approach to Improve Hypertension Among Black Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424730
• Other study ID #: IRB00113617
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2025
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Sunit Chhetri
• Phone: 336-716-9309
• Email: schhetri[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Feasibility Interview
One audio-recorded interview with the participants lasting about 30-minutes

Behavioral:
• Team Based Equity Conscious Telemedicine Hypertension Intervention
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.
• Usual Care
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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Emergency Department and Urgent Care Visits	Number of clinic, urgent care and emergency department visits	Month 6
Other	Number of Subjects using Blood Pressure Monitors	Patient self-reported home BP monitor use	Month 6
Primary	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
Primary	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
Secondary	Change in Blood Pressure	Changes in Systolic and Diastolic Blood Pressure	Month 6
Secondary	Percentage of Medication adherence	Medication adherence using the Proportion of Days Covered	Month 6