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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS135533 | U.S. NIH Grant/Contract | View source | |
| AAAV1743 | Other Identifier | Columbia University Irving Medical Center Institutional Review Board |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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Primary Goal:
To test the hypothesis that among stroke patients 18-75 years with ≥3 SDOH risk factors, SHIFT will improve: (1) functional outcomes as measured by the SIS (Primary Outcome), (2) physiological outcomes as measured by changes in blood pressure and cognition, (secondary outcomes) and (3) epigenetic allostatic load biomarkers (exploratory outcome) such as DNA methylation (DNAm) and telomere length, at 6 months and 1-year post-stroke, compared with usual care (UC).
Adverse Social Determinants of Health (SDOH) have been shown increase stroke risk in a dose dependent manner. The SDOH-Homecare Intervention Focus Team (SHIFT) trial is a Phase 3, randomized, blinded outcome trial that tests the hypothesis that a homecare intervention shortly after discharge from an acute stroke unit by a team comprising a community health worker (CHW), a community social worker (CSW) and a community nurse (CN) can improve health outcomes among stroke patients with three or more SDOH compared with UC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The SHIFT intervention team, comprising a community health worker (CHW), community social worker (CSW), and community nurse (CN),will make a first home visit within 72 hours of hospital discharge, and make regular visits to address SDOH barriers identified for each patient, provide individualized counseling, and assist with medication management, risk factor control, and health literacy. |
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| Usual Care | No Intervention | All patients will be given standard discharge information, including culturally/racially sensitive stroke education materials for post-stroke care, signs and symptoms of acute stroke, and management of stroke risk factors. Homecare referrals and other rehabilitation services will continue to be provided to discharged patients according to standard-of-care and treating physician referrals. Follow up clinic appointments at 4-6 weeks post discharge will be made with a stroke neurologist per clinical protocol. Thus the only difference between intervention and usual care will be the SHIFT intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHIFT team intervention | Behavioral | The SHIFT team, comprising a community health worker (CHW), community social worker (CHW), and community nurse (CN) will visit the participant starting within 72 hours of hospital discharge and provide social service referrals related to food insecurity, housing, immigration, and employment, and assist with medical appointment preparation (CHW), deliver individualized counseling focused on coping skills, reducing caregiver strain, and the psychological distress associated with experiences of racism and SDOH (CSW), and address health literacy and review of treatment goals and medications (CN). |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale v3.0 | a validated measure of disability and health-related quality of life after stroke | baseline, 6 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | change in blood pressure from baseline | baseline, 6 months and 1 year |
| cognition | Montreal Cognitive Assessment battery (MoCA) |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | medication adherence | 6 months and 1 year |
| 30-day readmission rate | incidence of readmission to the hospital within 30 days of discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olajide Williams, MD | Contact | (212) 305-1710 | ow11@cumc.columbia.edu | |
| Randolph S Marshall, MD | Contact | (212) 305-8389 | rsm2@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Olajide Williams, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36192526 | Background | Harris J, Boehme A, Chan L, Moats H, Dugue R, Izeogu C, Pavol MA, Naqvi IA, Williams O, Marshall RS. Allostatic load predicts racial disparities in intracerebral hemorrhage cognitive outcomes. Sci Rep. 2022 Oct 3;12(1):16556. doi: 10.1038/s41598-022-20987-x. | |
| 38646736 | Background | Mallaiah J, Williams O, Allegrante JP. Development and Validation of a Stroke Literacy Assessment Test for Community Health Workers. Health Educ Behav. 2024 Oct;51(5):764-774. doi: 10.1177/10901981241245050. Epub 2024 Apr 22. |
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To share individual participant data (IPD) of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.
As per NIH/NINDS requirements
All items required by NIH/NINDS will be publicly shared.
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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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Phase 3, randomized, blinded outcome
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| baseline, 6 months and 1 year |
| Stroke Specific Quality of Life (SSQOL) | validated quality of life measure | 6 months and 1 year |
| 30 days post discharge |
| Epigenetic biomarkers of stress | DNA methylation, telomere length | baseline, 6 months and 1 year |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |