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Enrolling by Invitation

NCT Number: NCT07098286

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Hospital length of stay

    Time frame: From enrollment to hospital discharge, expected 1-5 days

    Researchers will examine whether hospital length of stay is reduced when patients are able to discharge to HIHR.

Other outcomes

  1. Self-reported physical function

    Time frame: Approximately 30-45 days after discharge from the hospital.

    Patients in both the HIHR and inpatient rehabilitation facility cohorts at Duke will respond to questions from the Patient Reported Outcome Measure Information System (PROMIS) physical function questionnaire. The computer-adapted version of this questionnaire will be used, meaning that patients will respond to 4-8 total questions. Researchers will use the PROMIS T-scale scores for this study. Those scores range from 0-100 with higher scores indicating higher levels of function.

  2. Self-reported satisfaction with social roles

    Time frame: Approximately 30-45 days after discharge from the hospital

    Patients in both the HIHR and inpatient rehabilitation facility cohorts at Duke will respond to questions from the Patient Reported Outcome Measure Information System (PROMIS) satisfaction with social roles questionnaire. The computer-adapted version of this questionnaire will be used, meaning that patients will respond to 4-8 total questions. Researchers will use the PROMIS T-scale scores for this study. Those scores range from 0-100 with higher scores indicating higher levels of satisfaction with social roles.

  3. Self-reported resilience

    Time frame: Approximately 30-45 days after hospital discharge

    Patients in both the HIHR and inpatient rehabilitation facility cohorts at Duke will respond to questions from the Brief Resilience Score questionnaire. The Brief Resilience Scale (BRS) is a validated self-report instrument designed to assess an individual's ability to recover from stress and adversity. It consists of six items rated on a 5-point Likert scale, with higher scores indicating greater resilience.

  4. Perceived acceptability of HIHR as a model for post-stroke rehabilitation

    Time frame: Approximately 45-60 days after hospital discharge

    The subgroup of patients in the HIHR cohort at Duke who participate in the interviews will complete the Acceptability of Intervention Measure (AIM) in relation to the perception about HIHR as a model for post-stroke rehabilitation. The AIM includes 4 items, each with a 5-point Likert response. Total scores are 5-20 with higher scores indicating greater acceptability.

  5. Perceived appropriateness of HIHR as a model for post-stroke rehabilitation

    Time frame: Approximately 45-60 days after hospital discharge

    The subgroup of patients in the HIHR cohort at Duke who participate in the interviews will complete the Intervention Appropriateness Measure (IAM) in relation to the perception about HIHR as a model for post-stroke rehabilitation. The IAM includes 4 items, each with a 5-point Likert response. Total scores are 5-20 with higher scores indicating greater perceived appropriateness.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Claude D. Pepper Older American Independence Centers (OAICS)

Registry information

Acronym: HIHR

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Aug 1, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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