Columbia University Medical Center
New York, 10032, United States
Location status: Recruiting
NCT Number: NCT06397937
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).
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
New York, 10032, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: baseline, 6 months and 1 year
a validated measure of disability and health-related quality of life after stroke
Time frame: baseline, 6 months and 1 year
change in blood pressure from baseline
Time frame: baseline, 6 months and 1 year
Montreal Cognitive Assessment battery (MoCA)
Time frame: 6 months and 1 year
validated quality of life measure
Time frame: 6 months and 1 year
medication adherence
Time frame: 30 days post discharge
incidence of readmission to the hospital within 30 days of discharge
Time frame: baseline, 6 months and 1 year
DNA methylation, telomere length
Contact information is provided by the study sponsor or research team.
Olajide Williams, MD
CONTACT
Randolph S Marshall, MD
CONTACT
Columbia University
Other
The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Social Determinants of Stroke Outcomes and Build Community Capacity (The SHIFT Trial)
Acronym: SHIFT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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