ClinicalTrials.gg
CompletedNCT03485820COMPASSUpdated Nov 4, 2026Results posted

A Novel Transition Program to Reduce Disability After Stroke

An interventional study of COMPASS and Stroke education in Ischemic Stroke and Hemorrhagic Stroke, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 480 studies in Ischemic Stroke with a site in United States — 122 open to participants now, 146 under way, 13 of them phase 3. Ischemic Stroke · United States.

Enrollment
107th of 364
185 · median 66
Started
2018
with 26 others
No phase
183 of 480
53 open now
Registered
211th of 480
by date

Among the 480 studies in Ischemic Stroke with a site in United States, this one is the 107th largest by enrollment of the 364 interventional ones that give a count, is one of 27 that started in 2018, is one of 183 with no phase, and was the 211th registered.

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

122 of the 480 studies in Ischemic Stroke with a site in United States are open now. Recruiting first, the newest first:

117 more — sign in →

All 122 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 655 Ischemic Stroke studies recruiting now, 394 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 41 take healthy volunteers.

This study: 50 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Ischemic Stroke
  • Hemorrhagic Stroke

Keywords

  • environmental modifications
  • activity performance
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • severe terminal systemic disease that limits 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    COMPASS

    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.

    Behavioral: COMPASS

  • Sham comparator
    Education program

    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.

    Behavioral: Stroke education

Interventions

  • BehavioralCOMPASS

    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.

  • BehavioralStroke education

    The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 12 months post-stroke

Secondary outcomes

  1. 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.

    Time frame: Baseline and 12 months post-stroke

  2. 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.

    Time frame: Baseline and 12 months post-stroke

  3. 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.

    Time frame: Baseline and 12 months post-stroke

  4. 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.

    Time frame: Baseline and 12-months post-stroke

  5. 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.

    Time frame: Baseline and 12-months post-stroke

07

Results

Posted Mar 5, 2025

Participant flow

Participant flow — Overall Study
MilestoneCOMPASSEducation Program
Started85100
Completed7766
Not completed834

Outcome measures

PrimaryReintegration 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.

Time frame:
Baseline and 12 months post-stroke
Reported as:
Least squares mean · score on a scale
Reintegration to Normal Living Index (RNLI)
score on a scaleCOMPASSEducation Program
Baseline60.8 ± 2.261.2 ± 2.2
12-month follow-up74.8 ± 2.473.9 ± 2.6
Statistical analysis
  • COMPASS vs Education Program · Mixed Models Analysis · p = 0.76 (P value shown is for group by time interaction.) · Mean difference (net): 1.3 · 95% CI -7.1 to 9.6Between group differences in changes over time (COMPASS vs Education program)
SecondaryStroke 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.

Time frame:
Baseline and 12 months post-stroke
Reported as:
Least squares mean · score on a scale
Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain
score on a scaleCOMPASSEducation Program
Baseline55.3 ± 2.357.0 ± 2.3
12-month follow-up66.4 ± 2.469.9 ± 2.6
Statistical analysis
  • COMPASS vs Education Program · Mixed Models Analysis · p = 0.60 (P value shown is for group by time interaction.) · Mean difference (net): -1.8 · 95% CI -8.6 to 5.0Between group differences in changes over time (COMPASS vs Education program)
SecondaryIn-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.

Time frame:
Baseline and 12 months post-stroke
Reported as:
Least squares mean · score on a scale
In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score
score on a scaleCOMPASSEducation Program
Baseline0.73 ± 0.020.73 ± 0.02
12-month follow-up0.77 ± 0.020.78 ± 0.02
Statistical analysis
  • COMPASS vs Education Program · Mixed Models Analysis · p = 0.83 (P value shown is for group by time interaction.) · Mean difference (net): -0.01 · 95% CI -0.06 to 0.05Between group differences in changes over time (COMPASS vs Education program)
SecondaryIn-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.

Time frame:
Baseline and 12 months post-stroke
Reported as:
Least squares mean · score on a scale
In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score
score on a scaleCOMPASSEducation Program
Baseline2.42 ± 0.102.65 ± 0.09
12-month follow-up3.60 ± 0.103.44 ± 0.11
Statistical analysis
  • COMPASS vs Education Program · Mixed Models Analysis · p = 0.046 (P value shown is for group by time interaction.) · Mean difference (net): 0.39 · 95% CI 0.01 to 0.77Between group differences in changes over time (COMPASS vs Education program)
SecondaryIn-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.

Time frame:
Baseline and 12-months post-stroke
Reported as:
Least squares mean · score on a scale
In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score
score on a scaleCOMPASSEducation Program
Baseline2.24 ± 0.112.53 ± 0.11
12-month follow-up3.56 ± 0.123.33 ± 0.13
Statistical analysis
  • COMPASS vs Education Program · Mixed Models Analysis · p = 0.02 (P value shown is for group by time interaction.) · Mean difference (net): 0.52 · 95% CI 0.08 to 0.96Between group differences in changes over time (COMPASS vs Education program)
SecondaryIn-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.

Time frame:
Baseline and 12-months post-stroke
Reported as:
Least squares mean · score on a scale
In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score
score on a scaleCOMPASSEducation Program
Baseline67.0 ± 3.664.4 ± 3.5
12-month follow-up30.5 ± 3.838.4 ± 4.1
Statistical analysis
  • COMPASS vs Education Program · Mixed Models Analysis · p = 0.07 (P value shown is for group by time interaction.) · Mean difference (net): -10.6 · 95% CI -21.9 to 0.8Between group differences in changes over time (COMPASS vs Education program)

Adverse events

Collected over 1 year post-stroke. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
COMPASS0/85 (0%)0/85 (0%)0/85 (0%)
Education Program0/100 (0%)0/100 (0%)0/100 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)COMPASSEducation ProgramTotal
Mean66.3 ± 9.066.3 ± 9.066.3 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)COMPASSEducation ProgramTotal
Female354580
Male5055105
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)COMPASSEducation ProgramTotal
Black4563108
White403676
Not listed011
Region of Enrollment
Region of Enrollment(participants)COMPASSEducation ProgramTotal
United States85100185
Marital status
Marital status(Participants)COMPASSEducation ProgramTotal
Married/partner484492
Single/divorced/widowed375693
Living situation
Living situation(Participants)COMPASSEducation ProgramTotal
Lives alone263258
Lives with someone5968127
Type of stroke
Type of stroke(Participants)COMPASSEducation ProgramTotal
Ischemic7078148
Hemorrhagic152237
Comorbidities
Comorbidities(number of comorbidities present)COMPASSEducation ProgramTotal
Mean3.5 ± 1.83.5 ± 2.33.5 ± 2.1

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63108, United States
09

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Dec 2023, 71 months.

Results were first posted in Mar 2025, 1 year 2 months after primary completion.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 71 months is above that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2018
First posted
Apr 2, 2018
StartActual
Jan 9, 2018
Primary completionActual
Dec 20, 2023
CompletionActual
Feb 28, 2024
Results first posted
Mar 5, 2025
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03485820
Responsible party
Sponsor
First posted
Apr 2, 2018
Start date
Jan 9, 2018
Primary completion
Dec 20, 2023
Completion
Feb 28, 2024
Results posted
Mar 5, 2025
Last update
Nov 4, 2026

Study contacts

Susan Stark, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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