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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001873 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The Telehealth After Stroke Care (TASC) trial is a pilot randomized controlled trial. It aims to evaluate the feasibility of a telehealth based model providing multidisciplinary access including nursing, pharmacy and physician care, and obtain preliminary evidence of efficacy of an integrated telehealth approach to blood pressure management after stroke.
Hypertension is the most modifiable risk factor for recurrent stroke. Blood pressure (BP) reduction is associated with decreased risk of stroke recurrence but remains poorly controlled in most survivors. Minority groups have a higher prevalence of uncontrolled BP and higher rates of stroke. Limited access contributes to challenges in post-stroke care. Telehealth After Stroke Care (TASC) will be a telehealth intervention that integrates remote BP monitoring and telehealth visits to enhance BP control and promote self-efficacy, with a multidisciplinary approach to improve clinical processes and health outcomes. The investigators will assess for feasibility and obtain preliminary evidence of efficacy. Fifty (50) eligible patients will be screened for inclusion prior to hospital discharge and randomized to TASC or usual care. TASC patients will receive a BP monitoring kit and electronic tablet. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy at 4 and 8 weeks and stroke neurologist. Usual care patients will be seen by a primary care nurse practitioner at 1-2 weeks and a stroke neurologist at 1 and 3 months. Data will be collected at 0 and 3 months. The primary outcome will be BP control (BP <140/90 mmHg) at 3 months. The secondary outcome will be self-efficacy in medication adherence and treatment. Interdisciplinary team competency, fidelity, and telehealth satisfaction surveys will be administered. Patient reported outcomes including depression, cognitive function, and socioeconomic determinants will also be collected. Integrated team-based interventions are needed to improve BP control and reduce racial disparities in post-stroke care. It may be feasible and effective in enhancing post-stroke BP control and promoting self-efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TASC Intervention | Experimental | TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. |
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| TASC Control | Active Comparator | Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Other | Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Systolic BP Control | The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be < 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants. | Up to 3 months |
| Percentage of Participants Who Completed at Least 1 Video Visit | This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence Percentage | Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imama Naqvi, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Neurological Institute of New York, Columbia University | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35410312 | Result | Naqvi IA, Cheung YK, Strobino K, Li H, Tom SE, Husaini Z, Williams OA, Marshall RS, Arcia A, Kronish IM, Elkind MSV. TASC (Telehealth After Stroke Care): a study protocol for a randomized controlled feasibility trial of telehealth-enabled multidisciplinary stroke care in an underserved urban setting. Pilot Feasibility Stud. 2022 Apr 11;8(1):81. doi: 10.1186/s40814-022-01025-z. | |
| 36314123 | Derived | Naqvi IA, Strobino K, Kuen Cheung Y, Li H, Schmitt K, Ferrara S, Tom SE, Arcia A, Williams OA, Kronish IM, Elkind MSV. Telehealth After Stroke Care Pilot Randomized Trial of Home Blood Pressure Telemonitoring in an Underserved Setting. Stroke. 2022 Dec;53(12):3538-3547. doi: 10.1161/STROKEAHA.122.041020. Epub 2022 Oct 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TASC Intervention | TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. |
| FG001 | TASC Control | Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TASC Intervention | TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Systolic BP Control | The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be < 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants. | Only data of evaluable participants were included in the analysis: 21 out of 25 TASC Intervention patients and 16 out of 25 TASC Control patients. | Posted | Number | percentage of participants | Up to 3 months |
|
Up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TASC Intervention | TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. TASC intervention: TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Imama Naqvi, MD | Columbia University | 646-426-3876 | ian2108@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2022 | Jul 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010342 | Patient Acceptance of Health Care |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Multidisciplinary Team Nursing: transitions of care, motivational interview w/ tailored infographics
Pharmacy: medication education, adherence and titration
Physician: patient tailored risk factor control, post stroke complications
Integrated Approach: Home BP monitoring with remote support, Telehealth visits by each discipline, Tailored BP infographics, Patient Reported Outcomes (PROs)
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| TASC intervention | Other | TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist. |
|
| BG001 | TASC Control | Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mmHg |
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| OG001 | TASC Control | Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. |
|
|
| Primary | Percentage of Participants Who Completed at Least 1 Video Visit | This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation. | Only data of evaluable participants were included in the analysis: 23 out of 25 TASC Intervention patients and 24 out of 25 TASC Control patients. | Posted | Number | percentage of participants | 3 months |
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|
|
| Secondary | Medication Adherence Percentage | Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention. | Only data of evaluable participants were included in the analysis: 21 out of 25 TASC Intervention patients and 16 out of 25 TASC Control patients. | Posted | Number | percentage of participants | 3 months |
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|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | TASC Control | Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. Usual care: Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |