Tailoring TM-HTN Intervention for Black Patients
- Conditions
- Hypertension
- Interventions
- Behavioral: Telemedicine management of HypertensionBehavioral: Usual Care
- Registration Number
- NCT06593119
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemedicine management of Hypertension intervention group Telemedicine management of Hypertension BP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training control group Usual Care 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.
- Primary Outcome Measures
Name Time Method Proportion of patients who are screened Month 6 Proportion of patients who are screened
Proportion of patients who are eligible Month 6 Proportion of patients who are eligible
Proportion of patients who agree to participate Month 6 Proportion of patients who agree to participate
Proportion of patients who decline Month 6 Proportion of patients who decline
Number of staff needed and time spent for intervention Month 6 staff training, technical support, troubleshooting
Proportion of completed self-measurement of Blood Pressure at home Month 6 Proportion of completed self-measurement of BP at home
Proportion of completed self-management contacts. Month 6 Proportion of completed self-management contacts.
- Secondary Outcome Measures
Name Time Method Change in Blood Pressure Month 6 Effect size for BP change at 6-months (both arms)
Medication adherence Month 6 Medication adherence using the Proportion of Days Covered and Domains of Subjective Extent of Nonadherence Measure (both arms)
Feasibility of Intervention Measure [FIM] Month 6 measured on a 5-point Likert scale - 'excellent', 'good', 'fair' or 'poor' - higher scores denotes better feasibility
Acceptability of Intervention Measure [AIM] Month 6 Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree)
Intervention Appropriateness Measure [IAM] 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.
Patient Assessment of Chronic Illness Care [PACIC] 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.
Organizational Readiness for Implementing Change [ORIC] 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.
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States