StrokeHIHRNCT07098286
Enhancing Resilience Among Patients With Stroke: Implementation of High Intensity Home-based Rehabilitation
An observational study of Stroke and Stroke Rehabilitation, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Rehabilitation
- What is being tested?
- high intensity home-based rehabilitation
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for an acute stroke at Duke University Hospital who meet the eligibility criteria
Who may be able to join
- 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
Show all 10Show fewer
- 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)
- Clinically judged to have adequate caregiver support at home
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Being tested
- high intensity home-based rehabilitation
- Keywords
- Rehabilitation Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity home-based rehabilitationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of the HIHR episode, approximately 7-14 days.
Secondary outcomes (1)
Hospital length of stay
Researchers will examine whether hospital length of stay is reduced when patients are able to discharge to HIHR.
Measured: From enrollment to hospital discharge, expected 1-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start25 Aug 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Claude D. Pepper Older American Independence Centers (OAICS), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Joshua K. Johnson, DPT, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098286
- Sponsor's protocol ID
- Pro00114972
- Acronym
- HIHR
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Resilience Among Patients With Stroke: Implementation of High Intensity Home-based Rehabilitation
- ClinicalTrials.gov ID
- NCT07098286
- Acronym / sponsor ID
- HIHR / Pro00114972
- Conditions
- Stroke, Stroke Rehabilitation
- Keywords
- Rehabilitation Therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Claude D. Pepper Older American Independence Centers (OAICS), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High intensity home-based rehabilitation (HIHR) prospective cohort at Duke | – | Other: high intensity home-based rehabilitationThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for an acute stroke at Duke University Hospital who meet the eligibility criteria
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high intensity home-based rehabilitationWhereas 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. | Other | High intensity home-based rehabilitation (HIHR) prospective cohort at Duke |
Primary outcome
Physical function
Time frame: From enrollment to the end of the HIHR episode, approximately 7-14 days.
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).
1 secondary outcome
Hospital length of stay
Time frame: From enrollment to hospital discharge, expected 1-5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua K. Johnson, DPT, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke Rehabilitation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: From enrollment to the end of the HIHR episode, approximately 7-14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.