Compass 3: A Novel Transition Program to Reduce Disability After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COMPASS, Education Program.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Compass 3: A Novel Transition Program to Reduce Disability After a Stroke
Overview
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.
Interventions
- Behavioral COMPASS
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 - Behavioral Education Program
The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
Primary outcome measures
- Admission to SNF (skilled nursing facility) [Time frame: From enrollment to 12 months post-discharge from inpatient rehabilitation facility]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Missouri — Columbia
- Washington University in St. Louis — St Louis
Identifiers
NCT: NCT07069660 · 202501232 · 2R01HD092398-06A1