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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07098286
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • high intensity home-based rehabilitation — OTHER
    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.

Study Details

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.

Key Dates

Start date
Aug 25, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: High intensity home-based rehabilitation (HIHR) prospective cohort at Duke
    The HIHR cohort at Duke will be the prospective intervention cohort. They will receive occupational, physical, and speech therapy services at frequencies that are greater than standard home care after a stroke. They may also receive home health aide services if deemed clinically appropriate. Data for this cohort of patients will be combined with data from the HIHR cohort at Cleveland Clinic and will be compared to data from the inpatient rehabilitation facility (usual care) retrospective cohort. These patients will also participate in phone-based surveys and may also choose to participate (with their primary at-home caregiver) in an interview with a study team member.
  • Arm: Inpatient rehabilitation facility (usual care) retrospective cohort
    These patients' data will be accessed retrospectively using the electronic health record at both Duke and Cleveland Clinic, and a Medicare database. Their data will be included if their hospital data confirms that they were eligible for discharge to HIHR but were discharged to an inpatient rehabilitation facility for post-acute rehabilitation. Data will be included if the hospital discharge occurred between October 2021 and December 2024. Data for this cohort of patients will be compared to data from the HIHR cohorts at both Duke and Cleveland Clinic.
  • Arm: High intensity home-based rehabilitation (HIHR) retrospective cohort at Cleveland Clinic
    This will be a retrospectively identified cohort of patients who were admitted to a Cleveland Clinic hospital for treatment of a stroke then discharged home to receive HIHR services from Cleveland Clinic Home Care. Data will be included for patients if their HIHR episode occurred between October 2021 and December 2024. Data for this cohort of patients will be combined with data from the HIHR cohort at Duke and will be compared to data from the inpatient rehabilitation facility (usual care) retrospective cohort.
  • Arm: Inpatient rehabilitation facility (usual care) cohort at Duke
    These will be patients admitted to Duke Hospital between August 2025 and July 2026 who met eligibility to discharge to HIHR but instead discharged to an inpatient rehabilitation facility. These patients will be contacted for potential study enrollment 30-60 days after their hospital discharge. If they consent to participate, they will respond to phone-based surveys with a member of the study team. They may also choose to participate (with their primary at-home caregiver) in an interview with a member of the study team.

Primary Outcome Measure

Physical function [ Time Frame: From enrollment to the end of the HIHR episode, approximately 7-14 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Duke University· Durham, NC

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