Team Based Equity Conscious Telemedicine Approach to Hypertension

NCT ID: NCT06424730

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2024-09-20

Brief 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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interview Group

Black patients or their family members; Black community faith leaders; primary care providers and research coordinators

Group Type: OTHER

Feasibility Interview

Intervention Type: OTHER

One audio-recorded interview with the participants lasting about 30-minutes

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

Group Type: EXPERIMENTAL

Team Based Equity Conscious Telemedicine Hypertension Intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Usual Care

Intervention Type: BEHAVIORAL

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.

Interventions

Feasibility Interview

One audio-recorded interview with the participants lasting about 30-minutes

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

One audio-recorded interview; Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention; Standard of Care

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yashashwi Pokharel, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00113617

Identifier Type: -

Identifier Source: org_study_id