Team Based Equity Conscious Telemedicine Approach to Hypertension

NCT06424730 | Withdrawn

• 1 other identifier: IRB00113617
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

high blood pressure; telemedicine; African-American

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Blood Pressure

  Month 6

• Percentage of Medication adherence

  Month 6

Other Outcomes (2)

• Number of Emergency Department and Urgent Care Visits

  Month 6

• Number of Subjects using Blood Pressure Monitors

  Month 6

Study Arms (3)

Interview Group

OTHER

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

Other: Feasibility Interview

Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention

EXPERIMENTAL

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

Usual Care

OTHER

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

Interventions

Feasibility Interview OTHER

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

Also known as: One audio-recorded interview

Interview Group

Team Based Equity Conscious Telemedicine Hypertension Intervention 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.

Also known as: Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention

Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention

Usual Care 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.

Also known as: Standard of Care

Usual Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American or Black
• Patients with last clinic systolic Blood Pressure \>140 mmHg or diastolic Blood Pressure \>90 mmHg or both

You may not qualify if:

• 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.

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

Methods; Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yashashwi Pokharel, MD, MSCR

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

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: This study has two main objectives. First, to evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a TET-HTN clinical trial (Aim 1). Second objective is to evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach (Aim 2).

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: September 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: April 25, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)