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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06424730
Other study ID # IRB00113617
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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