SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06397937
Status
Recruiting
Apply to this trial

Conditions

  • Social Determinants of Health
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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).

Key Dates

Start date
Sep 15, 2024
Status verified
Mar 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
275 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
    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.
  • No Intervention: Usual Care
    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.

Primary Outcome Measure

Stroke Impact Scale v3.0 [ Time Frame: baseline, 6 months and 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Randolph S Marshall, MD
[email protected]
212 305 8389

Find similar trials in New York, NY

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Columbia University Medical Center· New York, NY

Related Studies