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| ID | Type | Description | Link |
|---|---|---|---|
| U54NS081765-5162 | Other Identifier | National Institute of Neurological Disorders and Stroke (NINDS) | |
| U54NS081765 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home BP Telemonitoring (HBPTM) | Active Comparator | Participants will take home BP readings 3 days per week (morning and evening) for one week out of each month during the 12-month intervention. |
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| HBPTM + Nurse Case Management (NCM) | Experimental | Participants will complete the same Home BP Telemonitoring protocol and will also complete 20 counseling phone calls with a nurse case manager during the 12-month intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home BP Telemonitoring (HBPTM) | Behavioral | Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments. |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month systolic blood pressure (SBP) change | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 24-month stroke recurrence | 24 months | |
| Cost-effectiveness for reducing SBP at 12 months | 12 months | |
| Cost-effectiveness for reducing stroke recurrence at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in other stroke risk factors | lipids, blood glucose | 6, 12, 24 months |
| Change in health behaviors | diet, physical activity, medication adherence, weight loss |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38842799 | Derived | Ogedegbe G, Teresi JA, Williams SK, Ogunlade A, Izeogu C, Eimicke JP, Kong J, Silver SA, Williams O, Valsamis H, Law S, Levine SR, Waddy SP, Spruill TM. Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial. JAMA. 2024 Jul 2;332(1):41-50. doi: 10.1001/jama.2024.6609. | |
| 25873044 | Derived | Spruill TM, Williams O, Teresi JA, Lehrer S, Pezzin L, Waddy SP, Lazar RM, Williams SK, Jean-Louis G, Ravenell J, Penesetti S, Favate A, Flores J, Henry KA, Kleiman A, Levine SR, Sinert R, Smith TY, Stern M, Valsamis H, Ogedegbe G. Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Nurse Case Management (NCM) | Behavioral | Participants will complete 20 counseling phone calls with a nurse case manager (NCM) during the 12-month intervention: weekly calls for Months 1-2; biweekly calls for Months 3-4; and monthly calls for Months 5-12. The NCMs will provide self-management education, medication and appointment reminders, and will facilitate patient-provider communication. They will counsel patients on specific self-management behaviors using problem solving and motivational interviewing techniques. Target behaviors will include dietary changes, physical activity, weight loss, medication adherence, and smoking cessation. NCMs will also review patients' clinical information and provide feedback about abnormal lab results, and will communicate with the patient's physician as needed (e.g., regarding barriers). |
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| 24 Months |
| 6, 12, 24 months |
| Antihypertensive medication intensification | adding, changing dose, or changing class of medications | 6, 12, 24 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |