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
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.
- 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