Team Based Equity Conscious Telemedicine Approach to Hypertension

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension
• Intervention / Treatment: Other: Feasibility Interview; Behavioral: Team Based Equity Conscious Telemedicine Hypertension Intervention; Behavioral: Usual Care

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interview Group; Black patients or their family members; Black community faith leaders; primary care providers and research coordinators	Other: Feasibility Interview; One audio-recorded interview with the participants lasting about 30-minutes; Other Names: One audio-recorded interview
Experimental: Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention; Black patients with systolic blood pressure >140 mmHg on the last two clinic visits plus baseline systolic blood pressure >130 mmHg - deliver the TET-HTN intervention over six months	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.; Other Names: Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention
Other: Usual Care; Black patients with systolic blood pressure >140 mmHg on the last two clinic visits plus baseline systolic blood pressure >130 mmHg - 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.	Behavioral: 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.; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Medication adherence	Medication adherence using the Proportion of Days Covered	Month 6
Change in Blood Pressure	Changes in Systolic and Diastolic Blood Pressure	Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Emergency Department and Urgent Care Visits	Number of clinic, urgent care and emergency department visits	Month 6
Number of Subjects using Blood Pressure Monitors	Patient self-reported home BP monitor use	Month 6

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Yashashwi Pokharel, MD, MSCR, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: telemedicine; African-American; high blood pressure
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: IRB00113617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No