Ischemic StrokeCOMPASSNCT03485820

A Novel Transition Program to Reduce Disability After Stroke

A study testing COMPASS and Stroke education in people with Ischemic Stroke and Hemorrhagic Stroke, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates a program designed to help individuals transition home from inpatient rehabilitation 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 50 years and older
Conditions the study is for: Ischemic Stroke, Hemorrhagic Stroke
What is being tested?: COMPASS and Stroke education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 185 participants
Where: 1 siteUnited States
Study dates: 9 Jan 2018to 28 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

aged ≥50 years
acute ischemic or hemorrhagic stroke diagnosis
independent ADLs prior to stroke (premorbid Modified Rankin Scale Score ≤2)
plan to discharge to home

Who cannot join

severe terminal systemic disease that limits life expectancy to < 6 months
previous disorder (e.g. dementia) that makes interpretation of the self-rated scales difficult or Short Blessed Test (SBT) score of 10 or less (indicating significant cognitive impairment)
moderate to severe Aphasia as determined by the NIHSS Best Language rating of 2 or more
reside in congregate living facility.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: COMPASS: A Novel Transition Program to Reduce Disability After Stroke

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. The proposed study investigates the efficacy and safety of a novel enhanced rehabilitation-transition program to reduce environmental barriers and improve daily activity performance and community participation.

Conditions: Ischemic Stroke, Hemorrhagic Stroke
Being tested: COMPASS, Stroke education
Keywords: environmental modifications, activity performance
Medical subject headings: Ischemic Stroke, Hemorrhagic 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 three 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.
Stroke educationBehavioural
The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.

Study groups in NCT03485820
Study group	Role	What they receive
COMPASS	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. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions. Receives: Behavioral: COMPASS
Education program	Sham comparator	An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided. Receives: Behavioral: Stroke education

What is being measured

The primary outcome is the main question the study is designed to answer.

Reintegration to Normal Living Index (RNLI)
The RNLI is a disability-related quality-of life-instrument used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point scale, with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living.
Measured: Baseline and 12 months post-stroke

Secondary outcomes (5)

Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain
The SIS is a health-related quality of life (HRQoL) measure that quantifies the impact of stroke on a client's life, via questionnaire. The Activities of Daily Living (ADL) domain was used to measure daily activity performance. The scale ranges from 0 to 100, with higher scores indicating less difficulty.
Measured: Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score
The In-Home Occupational Performance Evaluation (I-HOPE) activity score measures current activity patterns of participants across 44 activities. The score ranges from 0 to 1.0, with a higher score indicating fewer problematic activities for the participant.
Measured: Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score
The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating of up to 10 participant-prioritized activities on a scale from 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty). Higher mean scores indicate better functional ability to perform tasks without difficulty.
Measured: Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score
The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating of up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with their performance of the activity) to 5 (very satisfied with their performance of the activity). Higher mean scores indicate more satisfaction with self-rated activity performance.
Measured: Baseline and 12-months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score
The In-Home Occupational Performance Evaluation (I-HOPE) barrier severity score is a total sum of barrier ratings (0=independent with/without a device, 1=stand-by assistance needed, 2=minimum assistance needed, 3=moderate assistance needed, 4=maximum assistance needed, 5=no activity ) for all identified barriers across up to 10 prioritized activities. Multiple barriers could be identified for each prioritized activity. Higher sum scores indicate a greater need for assistance/less independence for completion of functional activities. There is no maximum score.
Measured: Baseline and 12-months post-stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 201828 Feb 2024

First posted2 Apr 2018
Study start9 Jan 2018
Primary completion20 Dec 2023
Study completion28 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Ischemic 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
Model description: Single-blind, parallel-group, randomized controlled trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03485820
Sponsor's protocol ID: 201705047
Other IDs: 1R01HD092398-01
Acronym: COMPASS
Status last verified: Aug 2025
First submitted: 26 Mar 2018
Last updated: 27 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Krauss MJ, Somerville E, Poiter C, Bollinger RM, Holden BM, Blenden G, Kretzer D, Stark SL. Functional performance of patients with stroke during inpatient rehabilitation: a cross-sectional study of home and access visits. BMC Health Serv Res. 2025 Jan 7;25(1):34. doi: 10.1186/s12913-024-12167-6.
PubMed 39773227
Bollinger RM, Krauss MJ, Somerville EK, Holden BM, Blenden G, Hollingsworth H, Keleman AA, Carter A, McBride TD, Barker AR, Yan Y, Stark SL. Rehabilitation Transition Program to Improve Community Participation Among Stroke Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2437758. doi: 10.1001/jamanetworkopen.2024.37758.
PubMed 39374016
Krauss MJ, Holden BM, Somerville E, Blenden G, Bollinger RM, Barker AR, McBride TD, Hollingsworth H, Yan Y, Stark SL. Community Participation Transition After Stroke (COMPASS) Randomized Controlled Trial: Effect on Adverse Health Events. Arch Phys Med Rehabil. 2024 Sep;105(9):1623-1631. doi: 10.1016/j.apmr.2024.05.015. Epub 2024 May 19.
PubMed 38772517
Somerville E, Minor B, Keglovits M, Yan Y, Stark S. Effect of a Novel Transition Program on Disability After Stroke: A Trial Protocol. JAMA Netw Open. 2019 Oct 2;2(10):e1912356. doi: 10.1001/jamanetworkopen.2019.12356.
PubMed 31577356

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COMPASS: A Novel Transition Program to Reduce Disability After Stroke
ClinicalTrials.gov ID: NCT03485820
Acronym / sponsor ID: COMPASS / 201705047
Conditions: Ischemic Stroke, Hemorrhagic Stroke
Keywords: environmental modifications, activity performance
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
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: 9 Jan 2018 (actual)
Primary completion: 20 Dec 2023 (actual)
Study completion: 28 Feb 2024 (actual)
First posted: 2 Apr 2018 (actual)
Results: Posted 5 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Single-blind, parallel-group, randomized controlled trial

Arm	Type	Receives
COMPASS	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. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
Education program	Sham comparator	Behavioral: Stroke educationAn OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

aged ≥50 years
acute ischemic or hemorrhagic stroke diagnosis
independent ADLs prior to stroke (premorbid Modified Rankin Scale Score ≤2)
plan to discharge to home

Key exclusion criteria (4 listed)

severe terminal systemic disease that limits life expectancy to < 6 months
previous disorder (e.g. dementia) that makes interpretation of the self-rated scales difficult or Short Blessed Test (SBT) score of 10 or less (indicating significant cognitive impairment)
moderate to severe Aphasia as determined by the NIHSS Best Language rating of 2 or more
reside in congregate living facility.

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 three 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
Stroke educationThe 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

Reintegration to Normal Living Index (RNLI)
Time frame: Baseline and 12 months post-stroke
The RNLI is a disability-related quality-of life-instrument used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point scale, with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living.

5 secondary outcomes

Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain
Time frame: Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score
Time frame: Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score
Time frame: Baseline and 12 months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score
Time frame: Baseline and 12-months post-stroke
In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score
Time frame: Baseline and 12-months post-stroke

Results and safety

Results posted to the registry on 5 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COMPASS	85	77
Education Program	100	66

Primary outcome: Reintegration to Normal Living Index (RNLI)

Time frame: Baseline and 12 months post-stroke. Least squares mean (Standard Error). Unit: score on a scale

Measure	COMPASS n = 83	Education Program n = 90
Baseline	60.8 (2.2)	61.2 (2.2)
12-month follow-up	74.8 (2.4)	73.9 (2.6)

COMPASS vs Education Program: Mean Difference (Net): 1.3 (95% CI -7.1 to 9.6), p = 0.76, Mixed Models Analysis

Population analysed: Analyzed are all those included in the mixed model (excludes those with missing covariate data).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year post-stroke. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COMPASS	0 of 85 (0%)	0 of 85 (0%)	0 of 85
Education Program	0 of 100 (0%)	0 of 100 (0%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39773227Krauss MJ, Somerville E, Poiter C, Bollinger RM, Holden BM, Blenden G, Kretzer D, Stark SL. Functional performance of patients with stroke during inpatient rehabilitation: a cross-sectional study of home and access visits. BMC Health Serv Res. 2025 Jan 7;25(1):34. doi: 10.1186/s12913-024-12167-6.
Derived from this study: PubMed 39374016Bollinger RM, Krauss MJ, Somerville EK, Holden BM, Blenden G, Hollingsworth H, Keleman AA, Carter A, McBride TD, Barker AR, Yan Y, Stark SL. Rehabilitation Transition Program to Improve Community Participation Among Stroke Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2437758. doi: 10.1001/jamanetworkopen.2024.37758.
Derived from this study: PubMed 38772517Krauss MJ, Holden BM, Somerville E, Blenden G, Bollinger RM, Barker AR, McBride TD, Hollingsworth H, Yan Y, Stark SL. Community Participation Transition After Stroke (COMPASS) Randomized Controlled Trial: Effect on Adverse Health Events. Arch Phys Med Rehabil. 2024 Sep;105(9):1623-1631. doi: 10.1016/j.apmr.2024.05.015. Epub 2024 May 19.
Derived from this study: PubMed 31577356Somerville E, Minor B, Keglovits M, Yan Y, Stark S. Effect of a Novel Transition Program on Disability After Stroke: A Trial Protocol. JAMA Netw Open. 2019 Oct 2;2(10):e1912356. doi: 10.1001/jamanetworkopen.2019.12356.
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. This study is not recruiting at the moment.

Susan Stark, PhD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing COMPASS and Stroke education in people with Ischemic Stroke and Hemorrhagic Stroke, run by Washington University School of Medicine 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Aug 2025. 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. 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?

Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Reintegration to Normal Living Index (RNLI) (time frame: Baseline and 12 months post-stroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03485820, which also lists 4 linked publications.

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 27 Aug 2025.