Hemorrhagic Stroke, Ischemic Stroke
Conditions
Keywords
environmental modifications, activity performance
Brief 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.
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.
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single-blind, parallel-group, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintegration to Normal Living Index (RNLI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain | Baseline and 12 months post-stroke | 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. |
| In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score | Baseline and 12 months post-stroke | 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. |
| In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score | Baseline and 12 months post-stroke | 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. |
| In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score | Baseline and 12-months post-stroke | 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. |
| In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score | Baseline and 12-months post-stroke | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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), 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. | 85 |
| 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.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest. | 100 |
| Total | 185 |
Baseline characteristics
| Characteristic | Education Program | COMPASS | Total |
|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 9 | 66.3 years STANDARD_DEVIATION 9 | 66.3 years STANDARD_DEVIATION 9 |
| Comorbidities | 3.5 number of comorbidities present STANDARD_DEVIATION 2.3 | 3.5 number of comorbidities present STANDARD_DEVIATION 1.8 | 3.5 number of comorbidities present STANDARD_DEVIATION 2.1 |
| Functional Independence Measure | 79.5 units on a scale STANDARD_DEVIATION 18 | 76.1 units on a scale STANDARD_DEVIATION 18.2 | 77.9 units on a scale STANDARD_DEVIATION 18.1 |
| Geriatric Depression Scale - Short Form score | 3.1 units on a scale STANDARD_DEVIATION 2.8 | 3.5 units on a scale STANDARD_DEVIATION 2.7 | 3.3 units on a scale STANDARD_DEVIATION 2.7 |
| Length of stay in inpatient rehabilitation | 18.0 days STANDARD_DEVIATION 7.8 | 20.7 days STANDARD_DEVIATION 16.5 | 19.3 days STANDARD_DEVIATION 12.6 |
| Living situation Lives alone | 32 Participants | 26 Participants | 58 Participants |
| Living situation Lives with someone | 68 Participants | 59 Participants | 127 Participants |
| Marital status Married/partner | 44 Participants | 48 Participants | 92 Participants |
| Marital status Single/divorced/widowed | 56 Participants | 37 Participants | 93 Participants |
| Race/Ethnicity, Customized Black | 63 Participants | 45 Participants | 108 Participants |
| Race/Ethnicity, Customized Not listed | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 36 Participants | 40 Participants | 76 Participants |
| Region of Enrollment United States | 100 participants | 85 participants | 185 participants |
| Sex: Female, Male Female | 45 Participants | 35 Participants | 80 Participants |
| Sex: Female, Male Male | 55 Participants | 50 Participants | 105 Participants |
| Type of stroke Hemorrhagic | 22 Participants | 15 Participants | 37 Participants |
| Type of stroke Ischemic | 78 Participants | 70 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 100 |
| other Total, other adverse events | 0 / 85 | 0 / 100 |
| serious Total, serious adverse events | 0 / 85 | 0 / 100 |
Outcome results
Primary
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
Population: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| COMPASS | Reintegration to Normal Living Index (RNLI) | Baseline | 60.8 score on a scale | Standard Error 2.2 |
| COMPASS | Reintegration to Normal Living Index (RNLI) | 12-month follow-up | 74.8 score on a scale | Standard Error 2.4 |
| Education Program | Reintegration to Normal Living Index (RNLI) | Baseline | 61.2 score on a scale | Standard Error 2.2 |
| Education Program | Reintegration to Normal Living Index (RNLI) | 12-month follow-up | 73.9 score on a scale | Standard Error 2.6 |
Comparison: A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.p-value: 0.7695% CI: [-7.1, 9.6]Mixed Models Analysis
Secondary
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
Population: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| COMPASS | In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score | Baseline | 0.73 score on a scale | Standard Error 0.02 |
| COMPASS | In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score | 12-month follow-up | 0.77 score on a scale | Standard Error 0.02 |
| Education Program | In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score | Baseline | 0.73 score on a scale | Standard Error 0.02 |
| Education Program | In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score | 12-month follow-up | 0.78 score on a scale | Standard Error 0.02 |
Comparison: A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.p-value: 0.8395% CI: [-0.06, 0.05]Mixed Models Analysis
Secondary
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
Population: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| COMPASS | In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score | Baseline | 67.0 score on a scale | Standard Error 3.6 |
| COMPASS | In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score | 12-month follow-up | 30.5 score on a scale | Standard Error 3.8 |
| Education Program | In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score | Baseline | 64.4 score on a scale | Standard Error 3.5 |
| Education Program | In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score | 12-month follow-up | 38.4 score on a scale | Standard Error 4.1 |
Comparison: A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.p-value: 0.0795% CI: [-21.9, 0.8]Mixed Models Analysis
Secondary
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
Population: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| COMPASS | In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score | Baseline | 2.42 score on a scale | Standard Error 0.1 |
| COMPASS | In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score | 12-month follow-up | 3.60 score on a scale | Standard Error 0.1 |
| Education Program | In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score | Baseline | 2.65 score on a scale | Standard Error 0.09 |
| Education Program | In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score | 12-month follow-up | 3.44 score on a scale | Standard Error 0.11 |
Comparison: A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression , number of days in inpatient rehabilitation, and baseline calendar time.p-value: 0.04695% CI: [0.01, 0.77]Mixed Models Analysis
Secondary
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
Population: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| COMPASS | In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score | Baseline | 2.24 score on a scale | Standard Error 0.11 |
| COMPASS | In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score | 12-month follow-up | 3.56 score on a scale | Standard Error 0.12 |
| Education Program | In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score | Baseline | 2.53 score on a scale | Standard Error 0.11 |
| Education Program | In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score | 12-month follow-up | 3.33 score on a scale | Standard Error 0.13 |
Comparison: A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.p-value: 0.0295% CI: [0.08, 0.96]Mixed Models Analysis
Secondary
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
Population: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| COMPASS | Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain | Baseline | 55.3 score on a scale | Standard Error 2.3 |
| COMPASS | Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain | 12-month follow-up | 66.4 score on a scale | Standard Error 2.4 |
| Education Program | Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain | Baseline | 57.0 score on a scale | Standard Error 2.3 |
| Education Program | Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain | 12-month follow-up | 69.9 score on a scale | Standard Error 2.6 |
Comparison: A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.p-value: 0.695% CI: [-8.6, 5]Mixed Models Analysis