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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD016465-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this study is to examine the impact of a multidisciplinary telehealth-based model of outpatient stroke care on blood pressure control following stroke, and further, to evaluate its impact on racial disparities in post-stroke blood pressure control.
Blood pressure is poorly controlled for many stroke survivors and racial disparities in blood pressure control and stroke recurrence exist.
The purpose of this study is to examine the impact of a multidisciplinary, telehealth based, outpatient model of care on outcomes after stroke with a focus on blood pressure control. The Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Livings with Stroke and Transient Ischemic Attack (VIRTUAL) has several components including early follow-up via telehealth with a multidisciplinary team, remote blood pressure monitoring, and medication adjustment by a pharmacist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIRTUAL Intervention (Treatment) | Experimental | Participants assigned to intervention arm will have scheduled video telehealth appointments with a multidisciplinary team (Stroke provider, social worker, pharmacist) and remote telemonitoring of blood pressure with blood pressure medication adjustments biweekly as needed by pharmacists. |
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| Standard Care | Active Comparator | Participants assigned to standard care will follow-up with a stroke provider within 2 weeks of discharge and primary care as per usual recommendations. Participants will monitor their blood pressure on their own and pharmacists will contact participants monthly to review blood pressure. Pharmacists will make recommendations for blood pressure medication adjustment to participant primary care provider. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIRTUAL | Other | At the time of discharge, stroke survivors in the VIRTUAL arm will receive a package containing an iPad and a remote BP monitoring device that allows transmission of BP to the study team.The first telehealth visit will occur 7-14 days after discharge. Patient will be counseled on the importance of BP monitoring, salt reduction, and the importance of diet and exercise for stroke prevention. Medications, side effects and interactions will be reviewed. The social worker will refer the patient to specific resources according to social needs abd patient will be referred to a primary care provider if they do not have one. Subsequent video visits will be 1-month (30 days +/- 7) , 3 months (90 days +/- 14), and 5 months (150 days +/- 14) days after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 month blood pressure control (24-hour ambulatory) | Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg) | 6 months after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 12 month blood pressure control (24-hour ambulatory) | Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg) | 12 months after discharge |
| Composite Recurrent Vascular Events |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour ambulatory systolic blood pressure | 24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month |
| 24 hour ambulatory systolic blood pressure | 24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anjali Z Sharrief, MD, MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40796883 | Derived | Okpala M, Izeogu C, Wang M, Green C, Cooksey G, Nguyen T, Cohen S, Bryant L, Hernandez DC, Bernstam EV, Gonzales M, Conyers R, Chiadika O, Varacalli K, Savitz SI, Yamal JM, Sharrief AZ. Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Living with Stroke or Transient Ischemic Attack (VIRTUAL): protocol for a randomized controlled trial. Trials. 2025 Aug 12;26(1):288. doi: 10.1186/s13063-025-09003-5. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard care | Other | Participants randomized to standard care will receive an educational packet and a blood pressure monitor prior to hospital discharge. They will be contacted by a social worker to determine if they received their medications and appointments. The stroke practitioner will evaluate the patients at 7-14 days and then follow up according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities. The pharmacist will contact patients at 1-month (30 +/- 7 days) days over the telephone to review BP logs and will make recommendations to their primary care provider to adjust BP medications. Subsequent pharmacist calls will occur monthly until 6 months and recommendations for medication adjustments will be communicated to their primary care provider. |
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Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization)
| 12 months after discharge |
| Proportion of uninsured who obtain insurance | Proportion of uninsured patients who obtain insurance | 3 months after hospital discharge |
| Proportion of uninsured who obtain insurance | Proportion of uninsured patients who obtain insurance | 6 months after hospital discharge |
| Acute healthcare utilization | Number of hospital readmissions, emergency department (ED) visits, and urgent care visits | 3 months after hospital discharge |
| Acute healthcare utilization | Number of hospital readmissions, ED visits, and urgent care visits | 6 months after hospital discharge |
| Acute healthcare utilization | Number of hospital readmissions, ED visits, and urgent care visits | 12 months after hospital discharge |
| 12 month |
| 24 hour ambulatory diastolic blood pressure | 24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month |
| 24 hour ambulatory diastolic blood pressure | 24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month |
| Daytime ambulatory systolic blood pressure | Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month |
| Daytime ambulatory systolic blood pressure | Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month |
| Daytime ambulatory diastolic blood pressure | Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month |
| Daytime ambulatory diastolic blood pressure | Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month |
| Night time ambulatory systolic blood pressure | Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month |
| Night time ambulatory systolic blood pressure | Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month |
| Night time ambulatory diastolic blood pressure | Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month |
| Night time ambulatory diastolic blood pressure | Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month |
| Proportion of participants who quit smoking or attempt to quit smoking | Among participants who are tobacco users at time of enrollment | 6 months |
| Proportion of participants who quit smoking or attempt to quit smoking | Among participants who are tobacco users at time of enrollment | 12 months |
| Proportion of participants who quit smoking | Among participants who are tobacco users at time of enrollment | 6 months |
| Proportion of participants who quit smoking | Among participants who are tobacco users at time of enrollment | 12 months |
| Depressive symptoms as assessed by score on the Patient Health Questionnaire 9 | Patient Health Questionnaire 9 total score ranges from 0 to 27 | 6 months |
| Depressive symptoms as assessed by score on the Patient Health Questionnaire 9 | Patient Health Questionnaire 9 total score ranges from 0 to 27 | 12 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |