Hypertension
Conditions
Keywords
Telemedicine, socially disadvantaged, African American or Black patients
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.
Interventions
BEHAVIORALTelemedicine management of Hypertension
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
BEHAVIORALUsual Care
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
60 patients total (30 in the TM-HTN intervention group, 30 in the control group).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTCamelia Singletary, MPH
PRINCIPAL_INVESTIGATORYashashwi Pokharel, MD
Wake Forest University Health Sciences
Outcome results
None listed