HypertensionTM-HTNNCT06593119
Tailoring TM-HTN Intervention for Black Patients
A study testing Telemedicine management of Hypertension in people with Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telemedicine management of Hypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be African American or Black
- experiencing socially disadvantage
- Patients with systolic Blood Pressure ≥140 mmHg on their last two clinic visits and baseline systolic BP >130 mmHg using the mean of two research BP values measured by trained staff
- Subjects must be on stable Blood Pressure medications for the preceding 6 weeks
Who cannot join
- Unable to read or speak English
- diminished ability to measure home Blood Pressure
- chronic kidney disease ≥stage 4
- persistent/chronic atrial fibrillation
- severe hypertension >180/110 mmHg
- acute health changes in past 3 months increasing chance of Blood Pressure instability
- terminal illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Camelia Singletary, MPH, 336-713-7210, Camelia.Singletary@Advocatehealth.org
Yashashwi Pokharel, MD
About this study
Official title: Tailoring a Telemedicine Hypertension Management Intervention for Black Patients
Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control.
Read the detailed description
Telemedicine management of HTN (TM-HTN) can augment and overcome challenges by allowing more support for patients' HTN self-care skills, providing multiple home Blood Pressure values and overcoming failure to appropriately intensify treatment. TM-HTN consists of 1) home BP monitoring, 2) home BP based pharmacotherapy, and 3) telemedicine-based self-management support.
- Conditions
- Hypertension
- Being tested
- Telemedicine management of Hypertension, Usual Care
- Keywords
- Telemedicine, socially disadvantaged, African American or Black patients
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine management of HypertensionBehavioural
Also called TM-HTN
TM-HTN intervention includes tailored and frequent self-management support, home blood pressure monitoring, pharmacotherapy, and as-needed assistance for health-related social needs provided by pharmacists, nurses, community health workers, and social workers. This will be compared with usual care
Usual CareBehavioural
Also called Control Group
This includes usual clinic based HTN care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine management of Hypertension intervention group | Experimental | BP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training Receives: Behavioral: Telemedicine management of Hypertension |
| control group | Placebo comparator | This includes usual clinic based Hypertension care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP 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.
Proportion of patients who are screened
Proportion of patients who are screened
Measured: Month 6
Proportion of patients who are eligible
Proportion of patients who are eligible
Measured: Month 6
Proportion of patients who agree to participate
Proportion of patients who agree to participate
Measured: Month 6
Proportion of patients who decline
Proportion of patients who decline
Measured: Month 6
Number of staff needed and time spent for intervention
staff training, technical support, troubleshooting
Measured: Month 6
Proportion of completed self-measurement of Blood Pressure at home
Proportion of completed self-measurement of BP at home
Measured: Month 6
Proportion of completed self-management contacts.
Proportion of completed self-management contacts.
Measured: Month 6
Secondary outcomes (7)
Change in Blood Pressure
Effect size for BP change at 6-months (both arms)
Measured: Month 6
Medication adherence
Medication adherence using the Proportion of Days Covered and Domains of Subjective Extent of Nonadherence Measure (both arms)
Measured: Month 6
Feasibility of Intervention Measure [FIM]
measured on a 5-point Likert scale - 'excellent', 'good', 'fair' or 'poor' - higher scores denotes better feasibility
Measured: Month 6
Acceptability of Intervention Measure [AIM]
Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree)
Measured: Month 6
Intervention Appropriateness Measure [IAM]
The IAM uses a 5-point Likert scale, with scores ranging from "Completely Disagree" to "Completely Agree". The mean of the scores is calculated to determine the overall score.
Measured: Month 6
Patient Assessment of Chronic Illness Care [PACIC]
The Patient Assessment of Chronic Illness Care (PACIC) is scored by averaging the responses to all 20 items on the scale. The score ranges from 1 to 5, with higher scores indicating that patients feel more involved in their care and self-management.
Measured: Month 6
Organizational Readiness for Implementing Change [ORIC]
Organizational Readiness for Implementing Change (ORIC) is a 12-item instrument used to determine how well employees at an organization feel they can implement the change in processes required by a proposed intervention. Each item includes a Likert scale from 1 (Disagree) to 5 (Agree) - The range of each scale is -10 through 0 to +10. A negative scale score reflects an overall disagreement with items measuring the stage of change, whereas a positive score represents overall agreement.
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 posted19 Sep 2024
- Study startNov 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
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
- 60 patients total (30 in the TM-HTN intervention group, 30 in the control group).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yashashwi Pokharel, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593119
- Sponsor's protocol ID
- IRB00116281
- Other IDs
- 11773
- Acronym
- TM-HTN
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2024
- Last updated
- 19 Oct 2026
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring a Telemedicine Hypertension Management Intervention for Black Patients
- ClinicalTrials.gov ID
- NCT06593119
- Acronym / sponsor ID
- TM-HTN / IRB00116281
- Conditions
- Hypertension
- Keywords
- Telemedicine, socially disadvantaged, African American or Black patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Sep 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.
Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control.
Detailed description
Telemedicine management of HTN (TM-HTN) can augment and overcome challenges by allowing more support for patients' HTN self-care skills, providing multiple home Blood Pressure values and overcoming failure to appropriately intensify treatment. TM-HTN consists of 1) home BP monitoring, 2) home BP based pharmacotherapy, and 3) telemedicine-based self-management support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 60 patients total (30 in the TM-HTN intervention group, 30 in the control group).
| Arm | Type | Receives |
|---|---|---|
| Telemedicine management of Hypertension intervention group | Experimental | Behavioral: Telemedicine management of HypertensionBP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training |
| control group | Placebo comparator | Behavioral: Usual CareThis includes usual clinic based Hypertension care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be African American or Black
- experiencing socially disadvantage
- Patients with systolic Blood Pressure ≥140 mmHg on their last two clinic visits and baseline systolic BP >130 mmHg using the mean of two research BP values measured by trained staff
- Subjects must be on stable Blood Pressure medications for the preceding 6 weeks
Key exclusion criteria (7 listed)
- Unable to read or speak English
- diminished ability to measure home Blood Pressure
- chronic kidney disease ≥stage 4
- persistent/chronic atrial fibrillation
- severe hypertension >180/110 mmHg
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 |
|---|---|---|
| Telemedicine management of HypertensionAlso: TM-HTNTM-HTN intervention includes tailored and frequent self-management support, home blood pressure monitoring, pharmacotherapy, and as-needed assistance for health-related social needs provided by pharmacists, nurses, community health workers, and social workers. This will be compared with usual care | Behavioural | Telemedicine management of Hypertension intervention group |
| Usual CareAlso: Control GroupThis includes usual clinic based HTN care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice. | Behavioural | control group |
Primary outcome
Proportion of patients who are screened
Time frame: Month 6
Proportion of patients who are screened
Proportion of patients who are eligible
Time frame: Month 6
Proportion of patients who are eligible
Proportion of patients who agree to participate
Time frame: Month 6
Proportion of patients who agree to participate
Proportion of patients who decline
Time frame: Month 6
Proportion of patients who decline
Number of staff needed and time spent for intervention
Time frame: Month 6
staff training, technical support, troubleshooting
Proportion of completed self-measurement of Blood Pressure at home
Time frame: Month 6
Proportion of completed self-measurement of BP at home
Proportion of completed self-management contacts.
Time frame: Month 6
Proportion of completed self-management contacts.
7 secondary outcomes
Change in Blood Pressure
Time frame: Month 6
Medication adherence
Time frame: Month 6
Feasibility of Intervention Measure [FIM]
Time frame: Month 6
Acceptability of Intervention Measure [AIM]
Time frame: Month 6
Intervention Appropriateness Measure [IAM]
Time frame: Month 6
Patient Assessment of Chronic Illness Care [PACIC]
Time frame: Month 6
Organizational Readiness for Implementing Change [ORIC]
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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.
Yashashwi Pokharel, MD 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 Telemedicine management of Hypertension 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camelia Singletary, MPH (336.713.7210, Camelia.Singletary@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are screened (time frame: Month 6). The study lists 7 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 19 Oct 2026.