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NCT Number: NCT06593119

Tailoring TM-HTN 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location contact

Camelia Singletary, MPH

CONTACT

[email protected]

336-713-7210

Yashashwi Pokharel, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Telemedicine Management of Hypertension

Behavioral

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

Other names: TM-HTN

Usual Care

Behavioral

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.

Other names: Control Group

Primary outcomes

  1. Proportion of patients who are screened

    Time frame: Month 6

    Proportion of patients who are screened

  2. Proportion of patients who are eligible

    Time frame: Month 6

    Proportion of patients who are eligible

  3. Proportion of patients who agree to participate

    Time frame: Month 6

    Proportion of patients who agree to participate

  4. Proportion of patients who decline

    Time frame: Month 6

    Proportion of patients who decline

  5. Number of staff needed and time spent for intervention

    Time frame: Month 6

    staff training, technical support, troubleshooting

  6. Proportion of completed self-measurement of Blood Pressure at home

    Time frame: Month 6

    Proportion of completed self-measurement of BP at home

  7. Proportion of completed self-management contacts.

    Time frame: Month 6

    Proportion of completed self-management contacts.

Secondary outcomes

  1. Change in Blood Pressure

    Time frame: Month 6

    Effect size for BP change at 6-months (both arms)

  2. Medication adherence

    Time frame: Month 6

    Medication adherence using the Proportion of Days Covered and Domains of Subjective Extent of Nonadherence Measure (both arms)

  3. Feasibility of Intervention Measure [FIM]

    Time frame: Month 6

    measured on a 5-point Likert scale - 'excellent', 'good', 'fair' or 'poor' - higher scores denotes better feasibility

  4. Acceptability of Intervention Measure [AIM]

    Time frame: Month 6

    Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree)

  5. Intervention Appropriateness Measure [IAM]

    Time frame: Month 6

    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.

  6. Patient Assessment of Chronic Illness Care [PACIC]

    Time frame: Month 6

    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.

  7. Organizational Readiness for Implementing Change [ORIC]

    Time frame: Month 6

    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.

Other outcomes

  1. Number of clinic, urgent care and emergency department visits

    Time frame: Month 6

    Number of clinic, urgent care and emergency department visits from Electronic Medical Records (both arms).

  2. Patient self-reported home BP monitor use

    Time frame: Month 6

    Patient self-reported home BP monitor use and self-management referrals from EMR (usual care group only).

  3. Reasons for patient contact

    Time frame: Month 6

    Reasons for patient contact (scheduled, unscheduled calls [e.g., technical, intervention or safety related]) (TM-HTN arm only)

  4. patients with resistant hypertension

    Time frame: Month 6

    Subgroup analysis in patients with resistant hypertension

Study contacts

Contact information is provided by the study sponsor or research team.

Camelia Singletary, MPH

CONTACT

[email protected]

336.713.7210

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Tailoring a Telemedicine Hypertension Management Intervention for Black Patients

Acronym: TM-HTN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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