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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REBIL- Intervention arm | Experimental | Participants in this arm will receive the Removing Environmental Barriers to Independent Living (REBIL) intervention. |
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| Waitlist Attentional control | Other | Participants in this arm will receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removing Environmental Barriers to Independent Living (REBIL) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6-month follow up |
| 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). | Baseline and 6-month follow up |
| 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). | Baseline and 6-month follow up |
| 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. | Baseline and 6-month follow up |
| Reintegration to Normal Living Index (RNLI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Stark, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38529197 | Background | Chen SW, Somerville E, Devine M, Stark S. A protocol for Removing Environmental Barriers to Independent Living (REBIL): An adapted evidence-based occupational therapy intervention to increase community participation for individuals aging with long-term physical disabilities. Br J Occup Ther. 2022;86(5):349-58. doi: 10.1177/03080226221126901. |
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The data (feasibility, primary and secondary outcomes) will be shared via a data repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6-month follow up |
|
6 months from baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susy Stark | Washington University in St. Louis | 3142734114 | sstark@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2023 | Apr 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 2, 2024 | Apr 4, 2024 | ICF_001.pdf |
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Parallel-group, randomized control, participants in the waitlist control group will receive the intervention after 6-month follow up is completed
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The outcomes assessor will be masked.
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| Waitlist Attentional Control | Behavioral | 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. |
|
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.
| Baseline and 6-month follow-up |
| 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. | Baseline and 6-month follow up |
| 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). |
| Baseline and 6-month follow-up |
| 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. | 6 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Living situation | Count of Participants | Participants |
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| Receives assistance with daily activities | Count of Participants | Participants |
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| Work status | Count of Participants | Participants |
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| Use of mobility device | Count of Participants | Participants |
|
| PROMIS Depression | Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale-Short Form 8-item. Uncorrected t-scores were calculated by the PROMIS scoring system, with higher scores indicating higher level of depressive symptoms. A score of 50 is the average of the US general population, with a standard deviation of 10. | Mean | Standard Deviation | T-score |
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| OG001 | 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. |
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| 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). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6-month follow up |
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| 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). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6-month follow up |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6-month follow up |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6-month follow-up |
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| 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. | Posted | Least Squares Mean | Standard Error | number of fall hazards | Baseline and 6-month follow up |
|
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6-month follow-up |
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| 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). | Posted | Least Squares Mean | Standard Error | ratio | Baseline and 6-month follow-up |
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| 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. | Posted | Number | Rate of falls per 1000 participant days | 6 months |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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