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| ID | Type | Description | Link |
|---|---|---|---|
| 11773 | Other Grant/Funding Number | NHLBI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine management of Hypertension intervention group | Experimental | BP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training |
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| control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who are screened | Proportion of patients who are screened | Month 6 |
| Proportion of patients who are eligible | Proportion of patients who are eligible | Month 6 |
| Proportion of patients who agree to participate | Proportion of patients who agree to participate | Month 6 |
| Proportion of patients who decline | Proportion of patients who decline | Month 6 |
| Number of staff needed and time spent for intervention | staff training, technical support, troubleshooting | Month 6 |
| Proportion of completed self-measurement of Blood Pressure at home | Proportion of completed self-measurement of BP at home | Month 6 |
| Proportion of completed self-management contacts. | Proportion of completed self-management contacts. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | Effect size for BP change at 6-months (both arms) | Month 6 |
| Medication adherence | Medication adherence using the Proportion of Days Covered and Domains of Subjective Extent of Nonadherence Measure (both arms) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of clinic, urgent care and emergency department visits | Number of clinic, urgent care and emergency department visits from Electronic Medical Records (both arms). | Month 6 |
| Patient self-reported home BP monitor use |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camelia Singletary, MPH | Contact | 336.713.7210 | crsingle@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yashashwi Pokharel, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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60 patients total (30 in the TM-HTN intervention group, 30 in the control group).
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| 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. |
|
|
| Month 6 |
| Feasibility of Intervention Measure [FIM] | measured on a 5-point Likert scale - 'excellent', 'good', 'fair' or 'poor' - higher scores denotes better feasibility | Month 6 |
| Acceptability of Intervention Measure [AIM] | Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree) | Month 6 |
| Intervention Appropriateness Measure [IAM] | 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. | Month 6 |
| Patient Assessment of Chronic Illness Care [PACIC] | 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. | Month 6 |
| Organizational Readiness for Implementing Change [ORIC] | 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. | Month 6 |
Patient self-reported home BP monitor use and self-management referrals from EMR (usual care group only).
| Month 6 |
| Reasons for patient contact | Reasons for patient contact (scheduled, unscheduled calls [e.g., technical, intervention or safety related]) (TM-HTN arm only) | Month 6 |
| patients with resistant hypertension | Subgroup analysis in patients with resistant hypertension | Month 6 |
| D008722 | Methods |