Physical Disability
Conditions
Keywords
community participation, environmental modifications, home modifications, fall prevention
Brief summary
The purpose of this study is to determine the feasibility and efficacy of an adapted evidence-based program (REBIL) to reduce barriers to community participation and remove fall hazards at home for adults aging with physical disabilities.
Detailed description
Investigators will test the working hypothesis that the adapted program, focused on resolving environmental barriers, removing fall hazards, and building self-management skills in the home and community, will be feasible and superior to usual care for daily activity performance and participation outcomes in adults aging with physical disabilities.
Interventions
BEHAVIORALRemoving Environmental Barriers to Independent Living (REBIL)
REBIL is a complex intervention with two essential components: (1) removing environmental barriers and home hazards in the home tailored to the participant's unique abilities and limitations and (2) strategy training with the participant to help participant to be able to identify barriers in the home and community and identify potential resources and strategies to remove the barriers. Treatment includes one assessment session and four 75-minute visits in the home with an occupational therapist over 8 weeks, followed by a 6 -month assessment session by a blinded rater.
BEHAVIORALWaitlist Attentional Control
The waitlist attentional control group will receive an initial assessment session then four 75 minute interview visits from an occupational therapy graduate assistant, followed by a 6-month assessment session by a blinded rater. After the 6-month follow-up is completed this group will receive the REBIL intervention.
Sponsors
National Institute on Disability, Independent Living, and Rehabilitation Research
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be masked.
Intervention model description
Parallel-group, randomized control, participants in the waitlist control group will receive the intervention after 6-month follow up is completed
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 45-65 years * Self-report of difficulty with at least 2 daily activities using the Older Adult Retirement Survey Activities of Daily Living (OARS ADL) scale * onset of a physical disability 5 years prior to participation (e.g., spinal cord injury (SCI), cerebral palsy, post-polio syndrome, stroke, amputation). * live within 60 miles of the research lab
Exclusion criteria
* Currently institutionalized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Westmead Home Safety Assessment (WeHSA) Short Form | Baseline and 6-month follow up | The Westmead Home Safety Assessment (WeHSA) short form is a performance-based assessment of fall hazards in different spaces of the home (e.g., kitchen, bathroom, hallway, bedroom etc.). WeSHA scores indicate the total number of environmental fall hazards in the home. |
| In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score | Baseline and 6-month follow up | The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating across up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with the performance of the activity) to 5 (very satisfied with their performance of the activity). |
| In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score | Baseline and 6-month follow up | 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 scores indicate greater barrier severity. There is no maximum score. |
| Reintegration to Normal Living Index (RNLI) | Baseline and 6-month follow-up | The Reintegration to Normal Living Index is a disability-related quality-of life-instrument that will be 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 visual analog 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. |
| In-Home Occupational Performance Evaluation (I-HOPE) Activity Score | Baseline and 6-month follow up | 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 6-month follow up | The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating across up to 10 participant-prioritized activities on a scale of 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participation Scale | Baseline and 6-month follow-up | This scale comprises 25 diverse activities across four participation domains: routines, recreation, responsibilities, and relationships. Ratings were on a five-point Likert-type scale regarding the frequency of participation, the importance of the activity, and their self-efficacy in completing it. We calculated the ratio of number of important/very important activities they could perform very much/as much as they wanted (numerator) to the number of important/very important activities (denominator). |
| Fall Rate | 6 months | Participants reported monthly on the number of falls they experienced in the past month. A fall was defined as an unexpected event in which a person comes to rest on the ground, floor, or a lower level. Fall rates were calculated as the number of falls per 1000 observed participant days. |
| Fall Prevention Strategy Survey (FPSS) | Baseline and 6-month follow-up | The Fall Prevention Strategy Survey is a self-report instrument addressing protective behaviors related to fall risk among adults. It is an 11-item survey, scores range from 0 to 22 with higher scores indicating use of more fall prevention strategies. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| REBIL- Intervention Arm Participants in this arm received the Removing Environmental Barriers to Independent Living (REBIL) intervention.
Removing Environmental Barriers to Independent Living (REBIL): REBIL is a complex intervention with two essential components: (1) removing environmental barriers and home hazards in the home tailored to the participant's unique abilities and limitations and (2) strategy training with the participant to help participant to be able to identify barriers in the home and community and identify potential resources and strategies to remove the barriers. Treatment includes one assessment session and four 75-minute visits in the home with an occupational therapist over 8 weeks, followed by a 6 -month assessment session by a blinded rater. | 23 |
| Waitlist Attentional Control Participants in this arm were received life interview visits provided by a trained occupational therapist (OT) or OT student remotely for an equivalent amount of time to the treatment group. The waitlist control group will be offered the REBIL intervention after the 6-month follow-up is completed.
Waitlist Attentional Control: The waitlist attentional control group will receive an initial assessment session then four 75 minute interview visits from an occupational therapy graduate assistant, followed by a 6-month assessment session by a blinded rater. After the 6-month follow-up is completed this group will receive the REBIL intervention. | 24 |
| Total | 47 |
Baseline characteristics
| Characteristic | REBIL- Intervention Arm | Waitlist Attentional Control | Total |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 4.4 | 58.4 years STANDARD_DEVIATION 5.3 | 57.8 years STANDARD_DEVIATION 4.9 |
| Living situation Lives alone | 10 Participants | 10 Participants | 20 Participants |
| Living situation Lives with someone | 13 Participants | 14 Participants | 27 Participants |
| PROMIS Depression | 53.5 T-score STANDARD_DEVIATION 9.6 | 54.6 T-score STANDARD_DEVIATION 9 | 54.1 T-score STANDARD_DEVIATION 9.2 |
| Race/Ethnicity, Customized Race and ethnicity Black/African American | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Race and ethnicity Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race and ethnicity White | 13 Participants | 16 Participants | 29 Participants |
| Receives assistance with daily activities No | 9 Participants | 10 Participants | 19 Participants |
| Receives assistance with daily activities Yes | 14 Participants | 14 Participants | 28 Participants |
| Region of Enrollment United States | 23 participants | 24 participants | 47 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
| Use of mobility device None | 3 Participants | 2 Participants | 5 Participants |
| Use of mobility device Other device (e.g., cane, walker) | 14 Participants | 13 Participants | 27 Participants |
| Use of mobility device Wheelchair | 6 Participants | 9 Participants | 15 Participants |
| Work status Disability leave | 12 Participants | 15 Participants | 27 Participants |
| Work status Retired/other | 5 Participants | 2 Participants | 7 Participants |
| Work status Working full-time/part-time | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 0 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
Primary
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 6-month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| REBIL- Intervention Arm | In-Home Occupational Performance Evaluation (I-HOPE) Activity Score | Baseline | 0.73 score on a scale | Standard Error 0.03 |
| REBIL- Intervention Arm | In-Home Occupational Performance Evaluation (I-HOPE) Activity Score | 6-month follow up | 0.76 score on a scale | Standard Error 0.03 |
| Waitlist Attentional Control | In-Home Occupational Performance Evaluation (I-HOPE) Activity Score | Baseline | 0.72 score on a scale | Standard Error 0.03 |
| Waitlist Attentional Control | In-Home Occupational Performance Evaluation (I-HOPE) Activity Score | 6-month follow up | 0.69 score on a scale | Standard Error 0.03 |
Comparison: A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) 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 age, sex, race, and depression score at baseline.p-value: 0.068Mixed Models Analysis
Primary
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 scores indicate greater barrier severity. There is no maximum score.
Time frame: Baseline and 6-month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| REBIL- Intervention Arm | In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score | Baseline | 50.28 score on a scale | Standard Error 4.78 |
| REBIL- Intervention Arm | In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score | 6-month follow up27.79 | 21.93 score on a scale | Standard Error 4.78 |
| Waitlist Attentional Control | In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score | Baseline | 51.83 score on a scale | Standard Error 4.82 |
| Waitlist Attentional Control | In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score | 6-month follow up27.79 | 27.79 score on a scale | Standard Error 4.82 |
Comparison: A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) 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 age, sex, race, and depression score at baseline.p-value: 0.447Mixed Models Analysis
Primary
In-Home Occupational Performance Evaluation (I-HOPE) Performance Score
The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating across up to 10 participant-prioritized activities on a scale of 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty).
Time frame: Baseline and 6-month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| REBIL- Intervention Arm | In-Home Occupational Performance Evaluation (I-HOPE) Performance Score | Baseline | 2.49 score on a scale | Standard Error 0.15 |
| REBIL- Intervention Arm | In-Home Occupational Performance Evaluation (I-HOPE) Performance Score | 6-month follow up | 3.23 score on a scale | Standard Error 0.15 |
| Waitlist Attentional Control | In-Home Occupational Performance Evaluation (I-HOPE) Performance Score | Baseline | 2.52 score on a scale | Standard Error 0.15 |
| Waitlist Attentional Control | In-Home Occupational Performance Evaluation (I-HOPE) Performance Score | 6-month follow up | 2.87 score on a scale | Standard Error 0.15 |
Comparison: A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) 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 age, sex, race, and depression score at baseline.p-value: 0.063Mixed Models Analysis
Primary
In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score
The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating across up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with the performance of the activity) to 5 (very satisfied with their performance of the activity).
Time frame: Baseline and 6-month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| REBIL- Intervention Arm | In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score | Baseline | 2.12 score on a scale | Standard Error 0.17 |
| REBIL- Intervention Arm | In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score | 6-month follow-up | 2.86 score on a scale | Standard Error 0.17 |
| Waitlist Attentional Control | In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score | Baseline | 2.09 score on a scale | Standard Error 0.18 |
| Waitlist Attentional Control | In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score | 6-month follow-up | 2.74 score on a scale | Standard Error 0.18 |
Comparison: A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) 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 age, sex, race, and depression score at baseline.p-value: 0.724Mixed Models Analysis
Primary
Reintegration to Normal Living Index (RNLI)
The Reintegration to Normal Living Index is a disability-related quality-of life-instrument that will be 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 visual analog 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 6-month follow-up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| REBIL- Intervention Arm | Reintegration to Normal Living Index (RNLI) | Baseline | 65.59 score on a scale | Standard Error 3.56 |
| REBIL- Intervention Arm | Reintegration to Normal Living Index (RNLI) | 6-month follow up | 70.08 score on a scale | Standard Error 3.52 |
| Waitlist Attentional Control | Reintegration to Normal Living Index (RNLI) | Baseline | 66.10 score on a scale | Standard Error 3.72 |
| Waitlist Attentional Control | Reintegration to Normal Living Index (RNLI) | 6-month follow up | 68.90 score on a scale | Standard Error 3.72 |
Comparison: A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) 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 age, sex, race, work status, and depression score at baseline.p-value: 0.696Mixed Models Analysis
Primary
Westmead Home Safety Assessment (WeHSA) Short Form
The Westmead Home Safety Assessment (WeHSA) short form is a performance-based assessment of fall hazards in different spaces of the home (e.g., kitchen, bathroom, hallway, bedroom etc.). WeSHA scores indicate the total number of environmental fall hazards in the home.
Time frame: Baseline and 6-month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| REBIL- Intervention Arm | Westmead Home Safety Assessment (WeHSA) Short Form | Baseline | 10.52 number of fall hazards | Standard Error 1.05 |
| REBIL- Intervention Arm | Westmead Home Safety Assessment (WeHSA) Short Form | 6-month follow up | 7.04 number of fall hazards | Standard Error 1.05 |
| Waitlist Attentional Control | Westmead Home Safety Assessment (WeHSA) Short Form | Baseline | 9.94 number of fall hazards | Standard Error 1.05 |
| Waitlist Attentional Control | Westmead Home Safety Assessment (WeHSA) Short Form | 6-month follow up | 6.94 number of fall hazards | Standard Error 1.05 |
Comparison: A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) 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 age, sex, race, and depression score at baseline.p-value: 0.798Mixed Models Analysis
Secondary
Fall Prevention Strategy Survey (FPSS)
The Fall Prevention Strategy Survey is a self-report instrument addressing protective behaviors related to fall risk among adults. It is an 11-item survey, scores range from 0 to 22 with higher scores indicating use of more fall prevention strategies.
Time frame: Baseline and 6-month follow-up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| REBIL- Intervention Arm | Fall Prevention Strategy Survey (FPSS) | Baseline | 13.2 score on a scale | Standard Error 0.9 |
| REBIL- Intervention Arm | Fall Prevention Strategy Survey (FPSS) | 6-month follow up | 16.5 score on a scale | Standard Error 0.9 |
| Waitlist Attentional Control | Fall Prevention Strategy Survey (FPSS) | Baseline | 13.9 score on a scale | Standard Error 0.9 |
| Waitlist Attentional Control | Fall Prevention Strategy Survey (FPSS) | 6-month follow up | 15.2 score on a scale | Standard Error 0.9 |
Comparison: A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) 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 age, sex, race, and depression score at baseline.p-value: 0.135Mixed Models Analysis
Secondary
Fall Rate
Participants reported monthly on the number of falls they experienced in the past month. A fall was defined as an unexpected event in which a person comes to rest on the ground, floor, or a lower level. Fall rates were calculated as the number of falls per 1000 observed participant days.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REBIL- Intervention Arm | Fall Rate | 15 Rate of falls per 1000 participant days |
| Waitlist Attentional Control | Fall Rate | 17.6 Rate of falls per 1000 participant days |
Comparison: Fall rates were compared between REBIL and control groups using negative binomial regression. The model adjusted for age, sex, ace, and depression score at baseline. The null hypothesis was that fall rates do not differ between groups.p-value: 0.63195% CI: [0.4, 1.76]Negative binomial regression
Secondary
Participation Scale
This scale comprises 25 diverse activities across four participation domains: routines, recreation, responsibilities, and relationships. Ratings were on a five-point Likert-type scale regarding the frequency of participation, the importance of the activity, and their self-efficacy in completing it. We calculated the ratio of number of important/very important activities they could perform very much/as much as they wanted (numerator) to the number of important/very important activities (denominator).
Time frame: Baseline and 6-month follow-up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| REBIL- Intervention Arm | Participation Scale | Baseline | 0.54 ratio | Standard Error 0.05 |
| REBIL- Intervention Arm | Participation Scale | 6-month follow-up | 0.65 ratio | Standard Error 0.05 |
| Waitlist Attentional Control | Participation Scale | Baseline | 0.58 ratio | Standard Error 0.05 |
| Waitlist Attentional Control | Participation Scale | 6-month follow-up | 0.63 ratio | Standard Error 0.05 |
Comparison: A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) 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 age, sex, race, work status, and depression score at baseline.p-value: 0.291Mixed Models Analysis