SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorColumbia University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable cerebral amyloid angiopathy by Boston Criteria)
African American/Black or Hispanic race-ethnicity
Age 18-75 years old
Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care)
Disqualifiers
Discharge disposition to a long-term care facility.
Diagnosis of dementia or other neurological diagnosis that affects cognition
Diagnosis of active major depression
Aphasia severe enough to preclude initial examination
Trial design
Design model
Parallel
Treatments tested in this trial
SHIFT team intervention
BehavioralThe 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).
Treatment groups
275 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Stroke Impact Scale v3.0
a validated measure of disability and health-related quality of life after stroke
Time frame
baseline, 6 months and 1 yearSecondary outcomes
1
Blood pressure
change in blood pressure from baseline
Time frame
baseline, 6 months and 1 year2
cognition
Montreal Cognitive Assessment battery (MoCA)
Time frame
baseline, 6 months and 1 year3
Stroke Specific Quality of Life (SSQOL)
validated quality of life measure
Time frame
6 months and 1 yearOther outcomes
1
Medication Adherence
medication adherence
Time frame
6 months and 1 year2
30-day readmission rate
incidence of readmission to the hospital within 30 days of discharge
Time frame
30 days post discharge3
Epigenetic biomarkers of stress
DNA methylation, telomere length
Time frame
baseline, 6 months and 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov