StrokeCOMPASS 3NCT07069660
Compass 3: A Novel Transition Program to Reduce Disability After Stroke
A study testing COMPASS and Education Program in people with Stroke, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
This study evaluates a program designed to help individuals transition from inpatient rehabilitation to home following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- COMPASS and Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Sep 2025to 31 Mar 2030
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥55 years at the time of screening
- Acute stroke diagnosis (IS or ICH) verified by the stroke team or medical record
- Independent in activities of daily living (ADLs) prior to stroke (premorbid Modified Rankin Scale score ≤2)
- Plan to discharge to home from an IR
- Capable of giving informed consent which includes compliance with the requirements and duration of participation as listed in the Informed Consent Form (ICF).
Who cannot join
- Life expectancy <6 months
- Cognitive impairment that the participant's stroke team or a research team member believes impairs their ability to provide informed consent or make reasoned choice including the interpretation of the self-rated scales
- Any communication problem that would prevent study completion
- Residence in a congregate living facility
- Not eligible for a therapeutic pass
- Residence outside of the designated catchment area (specific catchment distance to be determined by each site)
- Site investigator's judgment that the participant would not be able to complete research procedures or interventions
- Participation in another research study that in the site investigator's judgment could interfere or conflict with this research study's assessments or interventions
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Missouri
Columbia, Missouri, 65211
Rachel Wolpert, PhD, 573-884-2418, wolpertr@health.missouri.edu
Rachel Wolpert, PhD
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Susan Stark, 314-935-2500, sstark@wustl.edu
About this study
Official title: Compass 3: A Novel Transition Program to Reduce Disability After a Stroke
This study evaluates a program designed to help individuals transition from inpatient rehabilitation to home following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.
Read the detailed description
A gap in care exists at the point of transition from inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have potential to significantly improve stroke survivors' long-term morbidity.
Investigators will conduct a randomized, controlled multi-center trial (RCT) and concurrent implementation evaluation and review of process data to examine therapeutic efficacy, cost-effectiveness and implementation potential of a compensatory intervention (COMPASS) designed to improve daily activity performance and participation outcomes in persons transitioning home from inpatient rehabilitation (IR) following a stroke.
- Conditions
- Stroke
- Being tested
- COMPASS, Education Program
- Keywords
- occupational therapy, stroke, adults, environmental modifications
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMPASSBehavioural
The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of solutions for each problem, implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
Education ProgramBehavioural
The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
| Study group | Role | What they receive |
|---|---|---|
| COMPASS intervention | Experimental | COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. Receives: Behavioral: COMPASS |
| Education Program | Sham comparator | A research team member will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topics may include stroke symptoms, risk factors and preventing stroke recurrence. Receives: Behavioral: Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission to SNF (skilled nursing facility)
Date and days of admission to a skilled nursing facility
Measured: From enrollment to 12 months post-discharge from inpatient rehabilitation facility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start29 Sep 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (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 Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Susan Stark, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069660
- Sponsor's protocol ID
- 202501232
- Other IDs
- 2R01HD092398-06A1
- Acronym
- COMPASS 3
- Status last verified
- Feb 2026
- First submitted
- 14 Jul 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final de-identified data will be preserved and shared with the public via WashU Research Data, an institutional repository managed by the Washington University in St. Louis Libraries. Datasets submitted to the data repository undergo curation prior to publication to ensure that the data are functioning, in the appropriate format, and well documented to facilitate long-term FAIRness (findable, accessible, interoperable and reusable). Submissions receive digital object identifiers minted with DataCite, and the library will retain the deposits for a minimum of 10 years.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compass 3: A Novel Transition Program to Reduce Disability After a Stroke
- ClinicalTrials.gov ID
- NCT07069660
- Acronym / sponsor ID
- COMPASS 3 / 202501232
- Conditions
- Stroke
- Keywords
- occupational therapy, stroke, adults, environmental modifications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 17 Jul 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.
This study evaluates a program designed to help individuals transition from inpatient rehabilitation to home following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.
Detailed description
A gap in care exists at the point of transition from inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have potential to significantly improve stroke survivors' long-term morbidity.
Investigators will conduct a randomized, controlled multi-center trial (RCT) and concurrent implementation evaluation and review of process data to examine therapeutic efficacy, cost-effectiveness and implementation potential of a compensatory intervention (COMPASS) designed to improve daily activity performance and participation outcomes in persons transitioning home from inpatient rehabilitation (IR) following a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMPASS intervention | Experimental | Behavioral: COMPASSCOMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. |
| Education Program | Sham comparator | Behavioral: Education ProgramA research team member will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topics may include stroke symptoms, risk factors and preventing stroke recurrence. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥55 years at the time of screening
- Acute stroke diagnosis (IS or ICH) verified by the stroke team or medical record
- Independent in activities of daily living (ADLs) prior to stroke (premorbid Modified Rankin Scale score ≤2)
- Plan to discharge to home from an IR
- Capable of giving informed consent which includes compliance with the requirements and duration of participation as listed in the Informed Consent Form (ICF).
Key exclusion criteria (8 listed)
- Life expectancy <6 months
- Cognitive impairment that the participant's stroke team or a research team member believes impairs their ability to provide informed consent or make reasoned choice including the interpretation of the self-rated scales
- Any communication problem that would prevent study completion
- Residence in a congregate living facility
- Not eligible for a therapeutic pass
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 |
|---|---|---|
| COMPASSThe data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of solutions for each problem, implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community. | Behavioural | COMPASS intervention |
| Education ProgramThe control group will experience the same effects of time and attention in the home but no effect on the outcome of interest. | Behavioural | Education Program |
Primary outcome
Admission to SNF (skilled nursing facility)
Time frame: From enrollment to 12 months post-discharge from inpatient rehabilitation facility
Date and days of admission to a skilled nursing facility
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 13 Feb 2026.
- Individual participant dataSharing planned: Yes. Final de-identified data will be preserved and shared with the public via WashU Research Data, an institutional repository managed by the Washington University in St. Louis Libraries. Datasets submitted to the data repository undergo curation prior to publication to ensure that the data are functioning, in the appropriate format, and well documented to facilitate long-term FAIRness (findable, accessible, interoperable and reusable). Submissions receive digital object identifiers minted with DataCite, and the library will retain the deposits for a minimum of 10 years.
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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.
Susan Stark, PhD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMPASS and Education Program in people with Stroke, run by Washington University School of Medicine at 2 sites 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Contact Susan Stark, PhD ((314)935-2551, sstark@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission to SNF (skilled nursing facility) (time frame: From enrollment to 12 months post-discharge from inpatient rehabilitation facility). 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 13 Feb 2026.