Homecare intervention to improve outcomes for stroke patients

The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Social Determinants of Stroke Outcomes and Build Community Capacity (The SHIFT Trial)

This study is testing if a special homecare program with support from health workers can help stroke patients aged 18-75 who face multiple challenges feel better and recover more effectively compared to regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 275 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Columbia University (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06397937 on ClinicalTrials.gov

What this trial studies

The SHIFT trial aims to evaluate the effectiveness of a homecare intervention for stroke patients aged 18-75 who have three or more social determinants of health (SDOH) risk factors. This randomized, blinded trial will compare the outcomes of patients receiving the SHIFT intervention, which includes support from community health workers, social workers, and nurses, against those receiving usual care. The primary focus is on improving functional outcomes, physiological measures, and exploring epigenetic biomarkers over a period of six months to one year post-stroke.

Who should consider this trial

Good fit: Ideal candidates are stroke patients aged 18-75 with at least three identified social determinants of health barriers.

Not a fit: Patients who do not have any social determinants of health barriers or those outside the specified age range may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance recovery and quality of life for stroke patients facing multiple social challenges.

How similar studies have performed: Previous studies have indicated that addressing social determinants of health can improve health outcomes, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 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)
* Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after
* Pre-stroke Modified Rankin Scale score of ≤3
* Residence in New York City.
* English or Spanish speaking.
* Can provide informed consent and engage in the initial assessment prior to stroke discharge
* Lives in a household with a telephone, and has a caregiver (family member or Home Health Aide) if not fully independent on discharge. If the patient requires a family member to assist with activities of daily living or decision-making, the family member must state a willingness to be present at home visits where their assistance is needed.

Exclusion Criteria:

* 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
* Impaired level of consciousness at initial cognitive assessment
* Subarachnoid hemorrhage
* Diagnosis of probable cerebral amyloid angiopathy by Boston criteria
* Life expectancy less than 1 year

Where this trial is running

New York, New York

• Columbia University Medical Center — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Olajide Williams, MD — Columbia University
• Study coordinator: Olajide Williams, MD

Conditions: Stroke, Social Determinants of Health, stroke, social determinants of health, health disparities, community health workers, home visits