NCT07098286

Enhancing Resilience Among Patients With Stroke: Implementation of High Intensity Home-based Rehabilitation

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to test whether a model of high-intensity home-based rehabilitation (HIHR) helps patients get good outcomes after treatment for a stroke at Duke University Hospital. The main question it aims to answer is: Do patients who receive HIHR services after their stroke recover their function at least as well as patients who discharge to an inpatient rehabilitation facility? Participants will not be assigned to any group. Rather, patients who choose to discharge from the hospital to their home and receive HIHR services after their stroke will be enrolled in the study so that researchers can compare their outcomes to those for other patients who instead discharged to an inpatient rehabilitation facility.

Detailed description

This study will test whether a model of high-intensity home-based rehabilitation (HIHR) helps patients get good outcomes after treatment for a stroke at Duke University Hospital. While research data for this study is being collected exclusively at Duke, it will be combined with data from Cleveland Clinic, where HIHR was developed and where patients can select it as a standard-of-care option for rehabilitation after their stroke. Data from patients in both hospital systems (i.e., a prospective HIHR cohort from Duke and a retrospective HIHR cohort from Cleveland Clinic) will be used to understand if patients' outcomes are at least as good when they use HIHR services compared to an inpatient rehabilitation facility. Researchers will use retrospective data from the Centers for Medicare and Medicaid services to compare outcomes for patients in the two HIHR cohorts to outcomes for similar patients in an inpatient rehabilitation facility cohort. To study both the ability of clinicians to implement HIHR and the outcomes that patients achieve, no one will be assigned to HIHR as a participant in this study at Duke. Rather, during their hospitalization, patients who are being treated for a stroke can decide whether they are interested in using HIHR services when they discharge. Those who do will be enrolled in the study, becoming part of the HIHR cohort. They will discharge to their own home to receive HIHR services in their home. These services will include occupational, physical, and/or speech therapy for at least six hours per week, which is significantly more than patients normally receive when discharging home. If considered necessary, patients who choose HIHR and enroll in the study may also receive nursing care and up to 32 hours of services from a home health aide. The clinical team taking care of participants in HIHR will meet weekly to discuss progress and ongoing care plans. The HIHR care episode is expected to last approximately 14 days for each patient. As follow-up for the study, every patient in the HIHR will be asked to respond to phone-based surveys with a member of the research team after their HIHR services end. Those who are interested can also participate in a 45-60 minute interview with one of the researchers. For those interviews, the patient's primary at-home caregiver will also be asked to enroll in the study in order to participate in the interview and share their experiences. Separately, the research team will recruit via phone some patients who discharged from Duke Hospital to an inpatient rehabilitation facility after treatment for their stroke. Patients in that group who agree to participate will also complete the phone-based surveys and can participate (with their primary at-home caregiver) in an interview with one of the researchers. The survey responses and the interviews for the HIHR group and the group of patients discharged to rehabilitation facilities will be compared by the researchers.

Conditions

• Stroke
• Stroke Rehabilitation

Interventions

Type	Name	Description
OTHER	high intensity home-based rehabilitation	Whereas standard home healthcare would include 1-3 visits per week of therapy services after a stroke, the HIHR intervention will include at least therapy visits per week. Between occupational, physical, and speech therapy, the frequency for each will match individual patient needs based on the type and severity of their stroke-related deficits.

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-07-31
• Completion: 2028-07-31
• First posted: 2025-08-01
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States