Stroke
Conditions
Keywords
stroke rehabilitation, barriers to independence, environmental support
Brief summary
Stroke is one of the most serious, disabling health conditions in the United States. Patients who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes for many persons with stroke may be low because of incomplete treatment. The investigators will conduct a randomized controlled trial and a process evaluation to examine the feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition program, Community Participation Transition after Stroke (COMPASS), designed to bridge inpatient rehabilitation and the home to support the performance of everyday activities.
Detailed description
We propose an enhanced rehabilitation transition program: Community Participation Transition after Stroke (COMPASS) is a compensatory intervention consisting of one pre-discharge and five post-discharge home visits by an occupational therapist to supplement usual care. This intervention is focused on resolving barriers to independence in daily activities and participation using environmental support and active practice of daily activities in an individual's real home (versus an idealized clinical setting). This is a new combination of evidence-based compensatory treatments delivered in a novel treatment setting (transition to home). Our long-term goal is the development of an effective intervention for a transition home designed to prevent excess disability for people living with stroke that could have an immediate effect and high public health significance.16 We will recruit 40 patients currently undergoing inpatient rehabilitation (IR) for ischemic stroke from longitudinal studies of stroke at Washington University School of Medicine (WUSM) and randomize them to receive six additional sessions of the enhanced rehabilitation transition program or attention control. Exploratory participation outcomes will be assessed by blinded evaluators at baseline, 6 months, 9 months, and 12 months after stroke. We will test the central hypothesis that COMPASS will be acceptable, feasible, and superior to attention control on measures of participation and daily activity performance at 6 months after stroke.
Interventions
BEHAVIORALEducation Group
Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
BEHAVIORALHome Modifications Group
The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥45 years old 2. acute ischemic stroke, verified by a neurologist 3. baseline National Institutes of Health Stroke Scale (NIHSS) ≥8 4. independent in activities of daily living prior to stroke (premorbid Rankin score of ≤2) 5. plan to discharge to home
Exclusion criteria
1. severe terminal systemic disease that limits life expectancy to \<6 months 2. previous disorder (e.g., dementia) that makes interpretation of the self-rated scales difficult or a Short Blessed Test (SBT) score of ≥9 (indicating significant cognitive impairment) 3. moderate to severe aphasia, as determined by the NIHSS Best Language rating of ≥2 4. residence in a congregate living facility 5. not eligible for a therapeutic pass
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and Severity of Falls (Calculated With an Algorithm) | 12 months | We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). Scores are as follows: 0, those with no falls, 1, those with one fall without serious injury, 2, those with at least two falls without serious injury, and 3, those with one or more falls causing serious injury. Maximum score of three indicates an increased severity of fall. We will compare the difference in scores between groups using t-tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Dose (Minutes) | 2 months | The does of the intervention as measured in minutes received by both groups. The number of minutes reported is the average of the total for each participant in each group. |
| Health Care Utilization, Number of Emergency Department Visits | 12 months | We analyzed health care utilization by examining the number of emergency department visits, outpatient physical and occupational therapy visits, and doctor visits. The total number of each was calculated for each participant and the average is reported here. |
| Intervention Dose, Number of Treatment Sessions | 2 months | The does of the intervention as measured by amount of treatment minutes received by both groups. The total number of treatment sessions was calculated for each participant and the average is reported here. |
| Health Care Utilization, Days of Hospitalization | 12 months | We analyzed health care utilization by examining the number of days participants in each group spent in the hospital. The total number of days was calculated for participants in each group and the average is reported here. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intervention Adherence | 9 months | Adherence to the intervention will be measured by examine the number of recommendations implemented per recommendations suggested. Long-term adherence will be calculated as the number of recommendations used at 9 months per recommendations suggested. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Education Group Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest. | 6 |
| Home Modifications Group Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community. | 9 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month Follow up | Lost to Follow-up | 0 | 2 |
| 6 Month Follow-up | change in health status | 0 | 1 |
| 9 Month Follow-up | Death | 0 | 1 |
| Intervention | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Education Group | Home Modifications Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Continuous | 64.7 years STANDARD_DEVIATION 8.21 | 66.9 years STANDARD_DEVIATION 7.96 | 66.0 years STANDARD_DEVIATION 7.85 |
| I-HOPE Environmental Barriers | 58.67 barrier score STANDARD_DEVIATION 35.01 | 85.44 barrier score STANDARD_DEVIATION 22.47 | 74.73 barrier score STANDARD_DEVIATION 30.18 |
| I-HOPE Satisfaction | 16.67 units on a scale STANDARD_DEVIATION 9.4 | 19.33 units on a scale STANDARD_DEVIATION 5.94 | 18.27 units on a scale STANDARD_DEVIATION 7.31 |
| In-Home Occupational Performance Measure (I-HOPE) Performance | 16.00 units on a scale STANDARD_DEVIATION 7.72 | 21.22 units on a scale STANDARD_DEVIATION 5.76 | 19.13 units on a scale STANDARD_DEVIATION 6.88 |
| Length of Stay in Inpatient Rehabilitation | 16.7 days STANDARD_DEVIATION 53.5 | 24.1 days STANDARD_DEVIATION 7.9 | 21.1 days STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 6 Participants |
| Region of Enrollment United States | 6 participants | 9 participants | 15 participants |
| Reintegration to Normal Living Index (RNLI) | 62.88 units on a scale STANDARD_DEVIATION 22.24 | 52.73 units on a scale STANDARD_DEVIATION 18.87 | 56.79 units on a scale STANDARD_DEVIATION 20.12 |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
| SIS Activity of Daily Living (ADL) Subscale | 52.83 units on a scale STANDARD_DEVIATION 15.03 | 37.11 units on a scale STANDARD_DEVIATION 17.09 | 43.4 units on a scale STANDARD_DEVIATION 17.64 |
| Stroke Impact Scale (SIS) Total | 40.83 units on a scale STANDARD_DEVIATION 22 | 38.33 units on a scale STANDARD_DEVIATION 21.79 | 39.33 units on a scale STANDARD_DEVIATION 21.12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 1 / 9 |
| other Total, other adverse events | 0 / 6 | 0 / 9 |
| serious Total, serious adverse events | 0 / 6 | 0 / 9 |
Outcome results
Primary
Rate and Severity of Falls (Calculated With an Algorithm)
We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). Scores are as follows: 0, those with no falls, 1, those with one fall without serious injury, 2, those with at least two falls without serious injury, and 3, those with one or more falls causing serious injury. Maximum score of three indicates an increased severity of fall. We will compare the difference in scores between groups using t-tests.
Time frame: 12 months
Population: 15 participants were randomized (treatment group n=9 and education group n=6). 12 participants were included in this analysis. One participant in the education group was not able to finish education visits and was excluded from the analysis. Two participants in the treatment group were lost to follow up (drop out due to change in health n=1, drop out due to death n=1), and were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Group | Rate and Severity of Falls (Calculated With an Algorithm) | 2 score on a scale | Standard Deviation 0.316 |
| Home Modifications Group | Rate and Severity of Falls (Calculated With an Algorithm) | 2 score on a scale | Standard Deviation 0 |
Secondary
Health Care Utilization, Days of Hospitalization
We analyzed health care utilization by examining the number of days participants in each group spent in the hospital. The total number of days was calculated for participants in each group and the average is reported here.
Time frame: 12 months
Population: 15 participants were randomized (treatment group n=9 and education group n=6). 12 participants were included in this analysis. One participant in the education group was not able to finish education visits and was excluded from the analysis. Two participants in the treatment group were lost to follow up (drop out due to change in health n=1, drop out due to death n=1), and were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Group | Health Care Utilization, Days of Hospitalization | 0 days | Standard Deviation 0 |
| Home Modifications Group | Health Care Utilization, Days of Hospitalization | .67 days | Standard Deviation 1.12 |
Secondary
Health Care Utilization, Number of Emergency Department Visits
We analyzed health care utilization by examining the number of emergency department visits, outpatient physical and occupational therapy visits, and doctor visits. The total number of each was calculated for each participant and the average is reported here.
Time frame: 12 months
Population: 15 participants were randomized (treatment group n=9 and education group n=6). 12 participants were included in this analysis. One participant in the education group was not able to finish education visits and was excluded from the analysis. Two participants in the treatment group were lost to follow up (drop out due to change in health n=1, drop out due to death n=1), and were excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education Group | Health Care Utilization, Number of Emergency Department Visits | Emergency Room Visits | .50 Number of visits | Standard Deviation 0.55 |
| Education Group | Health Care Utilization, Number of Emergency Department Visits | Outpatient physical therapy visits | 28.67 Number of visits | Standard Deviation 34.72 |
| Education Group | Health Care Utilization, Number of Emergency Department Visits | Outpatient occupational therapy visits | 36.00 Number of visits | Standard Deviation 36.3 |
| Education Group | Health Care Utilization, Number of Emergency Department Visits | Outpatient doctor visits | 10.33 Number of visits | Standard Deviation 10.86 |
| Home Modifications Group | Health Care Utilization, Number of Emergency Department Visits | Outpatient doctor visits | 26.11 Number of visits | Standard Deviation 30.1 |
| Home Modifications Group | Health Care Utilization, Number of Emergency Department Visits | Emergency Room Visits | .56 Number of visits | Standard Deviation 0.88 |
| Home Modifications Group | Health Care Utilization, Number of Emergency Department Visits | Outpatient occupational therapy visits | 19.44 Number of visits | Standard Deviation 24.14 |
| Home Modifications Group | Health Care Utilization, Number of Emergency Department Visits | Outpatient physical therapy visits | 26.11 Number of visits | Standard Deviation 30.1 |
Secondary
Intervention Dose (Minutes)
The does of the intervention as measured in minutes received by both groups. The number of minutes reported is the average of the total for each participant in each group.
Time frame: 2 months
Population: A total of 14 participants were analyzed. One participant in the education group was not able to finish the education visits and was excluded from this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Group | Intervention Dose (Minutes) | 354.8 number of treatment minutes | Standard Deviation 120.1 |
| Home Modifications Group | Intervention Dose (Minutes) | 365 number of treatment minutes | Standard Deviation 108.3 |
Secondary
Intervention Dose, Number of Treatment Sessions
The does of the intervention as measured by amount of treatment minutes received by both groups. The total number of treatment sessions was calculated for each participant and the average is reported here.
Time frame: 2 months
Population: A total of 14 participants were analyzed. One participant in the education group was not able to finish the education visits and was excluded from this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Group | Intervention Dose, Number of Treatment Sessions | 4.4 number of treatment sessions | Standard Deviation 1.3 |
| Home Modifications Group | Intervention Dose, Number of Treatment Sessions | 5 number of treatment sessions | Standard Deviation 1 |
Other Pre-specified
Intervention Adherence
Adherence to the intervention will be measured by examine the number of recommendations implemented per recommendations suggested. Long-term adherence will be calculated as the number of recommendations used at 9 months per recommendations suggested.
Time frame: 9 months
Population: 9 participants were randomized to the treatment group. 7 participants were included in this analysis. Two participants in the treatment group were lost to follow up (drop out due to change in health n=1, drop out due to death n=1), and were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education Group | Intervention Adherence | 71.25 percentage of recommendations used | Standard Deviation 31 |