Team Based Equity Conscious Telemedicine Approach to Hypertension

April 22, 2025 updated by: Wake Forest University Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Barriers / Facilitators for Recruitment
Time Frame: Day 1
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
Time Frame: Month 6
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Medication adherence
Time Frame: Month 6
Medication adherence using the Proportion of Days Covered
Month 6
Change in Blood Pressure
Time Frame: Month 6
Changes in Systolic and Diastolic Blood Pressure
Month 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Emergency Department and Urgent Care Visits
Time Frame: Month 6
Number of clinic, urgent care and emergency department visits
Month 6
Number of Subjects using Blood Pressure Monitors
Time Frame: Month 6
Patient self-reported home BP monitor use
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yashashwi Pokharel, MD, MSCR, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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