HypertensionNCT06424730
Team Based Equity Conscious Telemedicine Approach to Hypertension
A study testing Feasibility Interview and Team Based Equity Conscious Telemedicine Hypertension Intervention in people with Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Feasibility Interview and Team Based Equity Conscious Telemedicine Hypertension Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American or Black
- Patients with last clinic systolic Blood Pressure >140 mmHg or diastolic Blood Pressure >90 mmHg or both
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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
- Being tested
- Feasibility Interview, Team Based Equity Conscious Telemedicine Hypertension Intervention, Usual Care
- Keywords
- high blood pressure, telemedicine, African-American
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility InterviewOther
Also called One audio-recorded interview
One audio-recorded interview with the participants lasting about 30-minutes
Team Based Equity Conscious Telemedicine Hypertension InterventionBehavioural
Also called Team based Equity conscious Telemedicine Hypertension (TET-HTN) 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 CareBehavioural
Also called Standard of 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.
| Study group | Role | What they receive |
|---|---|---|
| Interview Group | Other | Black patients or their family members; Black community faith leaders; primary care providers and research coordinators Receives: 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 Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Month 6
Secondary outcomes (2)
Change in Blood Pressure
Changes in Systolic and Diastolic Blood Pressure
Measured: Month 6
Percentage of Medication adherence
Medication adherence using the Proportion of Days Covered
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start20 Sep 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Why it stopped: closed because we were funded for another similar study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yashashwi Pokharel, MD, MSCR, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424730
- Sponsor's protocol ID
- IRB00113617
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team Based Equity Conscious Telemedicine Approach to Improve Hypertension Among Black Patients
- ClinicalTrials.gov ID
- NCT06424730
- Acronym / sponsor ID
- IRB00113617
- Conditions
- Hypertension
- Keywords
- high blood pressure, telemedicine, African-American
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: closed because we were funded for another similar study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Interview Group | Other | Other: Feasibility InterviewBlack patients or their family members; Black community faith leaders; primary care providers and research coordinators |
| Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention | Experimental | Behavioral: Team Based Equity Conscious Telemedicine Hypertension InterventionBlack 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 |
| Usual Care | Other | Behavioral: Usual CareBlack 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- African American or Black
- Patients with last clinic systolic Blood Pressure >140 mmHg or diastolic Blood Pressure >90 mmHg or both
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility InterviewAlso: One audio-recorded interviewOne audio-recorded interview with the participants lasting about 30-minutes | Other | Interview Group |
| Team Based Equity Conscious Telemedicine Hypertension InterventionAlso: Team based Equity conscious Telemedicine Hypertension (TET-HTN) interventionWill 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. | Behavioural | Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention |
| Usual CareAlso: Standard of CareUsual 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. | Behavioural | Usual Care |
Primary outcome
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
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.
2 secondary outcomes
Change in Blood Pressure
Time frame: Month 6
Percentage of Medication adherence
Time frame: Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yashashwi Pokharel, MD, MSCR principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility Interview and Team Based Equity Conscious Telemedicine Hypertension Intervention in people with Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers / Facilitators for Recruitment (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.