TERMINATED

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

Conditions

Stroke Social Determinants of Health health disparities community health workers home visits

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-09-17

Study Completion:2025-03-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06397937

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable CAA) 2. Age 18-75 years old. 3. Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care). 4. Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after. 5. Pre-stroke Modified Rankin Scale score of ≤3 6. Residence in New York City.. 7. English or Spanish speaking. 8. Can provide informed consent and engage in the initial assessment prior to stroke discharge. 9. 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.	1. Discharge disposition to a long term care facility. 2. Diagnosis of dementia or other neurological neurological diagnosis that affects cognition. 3. Diagnosis of active major depression. 4. Aphasia severe enough to preclude initial examination. 5. Impaired level of consciousness at initial cognitive assessment. 6. Subarachnoid hemorrhage. 7. Diagnosis of probable cerebral amyloid angiopathy by Boston criteria. 8. Life expectancy less than 1 year.

Inclusion Criteria

Exclusion Criteria

1. Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable CAA)
2. Age 18-75 years old.
3. Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care).
4. Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after.
5. Pre-stroke Modified Rankin Scale score of ≤3
6. Residence in New York City..
7. English or Spanish speaking.
8. Can provide informed consent and engage in the initial assessment prior to stroke discharge.
9. 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.

1. Discharge disposition to a long term care facility.
2. Diagnosis of dementia or other neurological neurological diagnosis that affects cognition.
3. Diagnosis of active major depression.
4. Aphasia severe enough to preclude initial examination.
5. Impaired level of consciousness at initial cognitive assessment.
6. Subarachnoid hemorrhage.
7. Diagnosis of probable cerebral amyloid angiopathy by Boston criteria.
8. Life expectancy less than 1 year.

Contacts and Locations

Principal Investigator

Richard T Benson, MD

STUDY_DIRECTOR

NINDS Office of Global Health and Health Disparities

Study Locations (Sites)

Columbia University Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Richard T Benson, MD, STUDY_DIRECTOR, NINDS Office of Global Health and Health Disparities

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17

Study Completion Date2025-03-14

Study Record Updates

Study Start Date2024-09-17

Study Completion Date2025-03-14

Terms related to this study

Keywords Provided by Researchers

stroke
social determinants of health
health disparities
community health workers
home visits

Additional Relevant MeSH Terms

Stroke
Social Determinants of Health