Tailoring a Telemedicine Hypertension Management Intervention for Black Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Proportion of patients who are eligible
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Telemedicine management of Hypertension intervention group
BP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training
Intervention: Telemedicine management of Hypertension (Behavioral)
control group
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.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Proportion of patients who are eligible
Time Frame: Month 6
Proportion of patients who are eligible
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.
Proportion of patients who are screened
Time Frame: Month 6
Proportion of patients who are screened
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
Secondary Outcomes
- Change in Blood Pressure(Month 6)
- Medication adherence(Month 6)
- Feasibility of Intervention Measure [FIM](Month 6)
- Acceptability of Intervention Measure [AIM](Month 6)
- Intervention Appropriateness Measure [IAM](Month 6)
- Patient Assessment of Chronic Illness Care [PACIC](Month 6)
- Organizational Readiness for Implementing Change [ORIC](Month 6)