Clinical trial NCT06593119: Tailoring TM-HTN Intervention for Black Patients
Official title: Tailoring a Telemedicine Hypertension Management Intervention for Black Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Telemedicine
socially disadvantaged
African American or Black patients
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 patients total (30 in the TM-HTN intervention group, 30 in the control group).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who are screened
timeFrame: Month 6
measure: Proportion of patients who are eligible
timeFrame: Month 6
measure: Proportion of patients who agree to participate
timeFrame: Month 6
measure: Proportion of patients who decline
timeFrame: Month 6
measure: Number of staff needed and time spent for intervention
timeFrame: Month 6
measure: Proportion of completed self-measurement of Blood Pressure at home
timeFrame: Month 6
measure: Proportion of completed self-management contacts.
timeFrame: Month 6
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: Month 6
measure: Medication adherence
timeFrame: Month 6
measure: Feasibility of Intervention Measure [FIM]
timeFrame: Month 6
measure: Acceptability of Intervention Measure [AIM]
timeFrame: Month 6
measure: Intervention Appropriateness Measure [IAM]
timeFrame: Month 6
measure: Patient Assessment of Chronic Illness Care [PACIC]
timeFrame: Month 6
measure: Organizational Readiness for Implementing Change [ORIC]
timeFrame: Month 6
Other outcomes:
measure: Number of clinic, urgent care and emergency department visits
timeFrame: Month 6
measure: Patient self-reported home BP monitor use
timeFrame: Month 6
measure: Reasons for patient contact
timeFrame: Month 6
measure: patients with resistant hypertension
timeFrame: Month 6
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Yashashwi Pokharel, MD
role: PRINCIPAL_INVESTIGATOR
References: