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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04589988
Other study ID # 201710186
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 4, 2020
Est. completion date March 2024

Study information

Verified date July 2023
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen, S. W., Somerville, E., Devine, M., & Stark, S. (2022). 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. British Journal of Occupational Therapy, 03080226221126901.

Outcome

Type Measure Description Time frame Safety issue
Primary In-Home Occupational Performance Evaluation (I-HOPE) The In-Home Occupational Performance Evaluation will be used to measure current activity patterns of participants, identify activities that are difficult but important to them, and identify the environmental barriers that influence those activities (person-environment fit). Activity score: minimum value .5, maximum value 1, where a higher score indicates fewer problematic activities. Barrier scores: minimum value 0, maximum value 5, with higher scores indicating greater influence of barriers on activity. Change from baseline to 6-month follow up
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. Change from baseline and 6-month follow-up
Primary Westmead Home Safety Assessment (WeHSA) Short Form Environmental fall hazards Change from baseline to 6-month follow up
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. Change from baseline and 6-month follow-up
Secondary Nine Participation Domain Measures Descriptive information on activity participation and types of help needed; activities in four areas of participation (routines, recreation, responsibilities, and relationships) Change from baseline and 6-month follow-up
Secondary Falls Participants will report monthly on the number of falls they had. 6 months
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