- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04589988
Aging With Long Term Physical Disabilities
August 25, 2025 updated by: Washington University School of Medicine
Building Capacity to Improve Community Participation for People Aging With Long-Term Disability Through Evidence-Based Strategies
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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St Louis, Missouri, United States, 63108
- Washington University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: REBIL- Intervention arm
Participants in this arm will receive the Removing Environmental Barriers to Independent Living (REBIL) intervention.
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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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Other: Waitlist Attentional control
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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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In-Home Occupational Performance Evaluation (I-HOPE) Activity Score
Time Frame: Baseline and 6-month follow up
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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.
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Baseline and 6-month follow up
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In-Home Occupational Performance Evaluation (I-HOPE) Performance Score
Time Frame: Baseline and 6-month follow up
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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).
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Baseline and 6-month follow up
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In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score
Time Frame: Baseline and 6-month follow up
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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).
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Baseline and 6-month follow up
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In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score
Time Frame: Baseline and 6-month follow up
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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.
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Baseline and 6-month follow up
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Reintegration to Normal Living Index (RNLI)
Time Frame: Baseline and 6-month follow-up
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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.
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Baseline and 6-month follow-up
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Westmead Home Safety Assessment (WeHSA) Short Form
Time Frame: Baseline and 6-month follow up
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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.
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Baseline and 6-month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fall Prevention Strategy Survey (FPSS)
Time Frame: Baseline and 6-month follow-up
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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.
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Baseline and 6-month follow-up
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Participation Scale
Time Frame: Baseline and 6-month follow-up
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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).
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Baseline and 6-month follow-up
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Fall Rate
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan Stark, PhD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2020
Primary Completion (Actual)
June 21, 2023
Study Completion (Actual)
June 21, 2023
Study Registration Dates
First Submitted
September 8, 2020
First Submitted That Met QC Criteria
October 9, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Estimated)
August 27, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 201710186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The data (feasibility, primary and secondary outcomes) will be shared via a data repository.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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