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

NCT07098286 | Enrolling By Invitation

• 1 other identifier: Pro00114972
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Stroke Rehabilitation

Keywords

Rehabilitation Therapy

Outcome Measures

Primary Outcomes (1)

• Physical function

  The primary outcome will be physical function as measured by the Continuity Assessment Record and Evaluation (CARE) section GG form. This form, required by CMS for all post-acute care settings, will provide separate scores reporting physical function domains of mobility and self-care. Scores for the mobility domain range from 15 to 90. Scores for the self-care domain range from 8 to 48. For both, higher scores indicate greater independence with tasks consistent with that domain (e.g., walking for the mobility domain and dressing for the self-care domain).

  From enrollment to the end of the HIHR episode, approximately 7-14 days.

Secondary Outcomes (1)

• Hospital length of stay

  From enrollment to hospital discharge, expected 1-5 days

Other Outcomes (5)

• Self-reported physical function

  Approximately 30-45 days after discharge from the hospital.

• Self-reported satisfaction with social roles

  Approximately 30-45 days after discharge from the hospital

• Self-reported resilience

  Approximately 30-45 days after hospital discharge

Study Arms (4)

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.

Other: high intensity home-based rehabilitation

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.

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.

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.

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.

High intensity home-based rehabilitation (HIHR) prospective cohort at Duke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for an acute stroke at Duke University Hospital who meet the eligibility criteria

You may qualify if:

• Ability to read and understand English.
• Admitted to Duke University Hospital stroke medical service
• Confirmed diagnosis of stroke (per documentation in medical record)
• At time of hospital discharge:
• Home adress in the followng zipcodes: 27713, 27704, 27511, 27513, 27518, 27519, 27560, 27703, 27712, 27707, 27705 and 27701.
• NIH Stroke Scale Score = 4-13
• AM-PAC 6-Clicks basic mobility score \>/=13
• Documented need for rehabilitation from 2 disciplines in post-acute or for a Skilled Nursing Facility (SNF).
• No contraindications to safe medical management at home (ongoing cancer treatment, dialysis-dependent ESRD, complex wounds, others as determined by the attending medical team)
• g) Clinically judged to have adequate caregiver support at home

You may not qualify if:

• Those with acute psychosis or an inability to provide legal and effective consent will be excluded from participation.
• Those with medical contraindications as determined by the hospital attending neurology team

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Duke University: lead
• Claude D. Pepper Older American Independence Centers (OAICS): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joshua K. Johnson, DPT, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)