NCT04589988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 18, 2024

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

September 8, 2020

Results QC Date

May 14, 2024

Last Update Submit

August 25, 2025

Conditions

Keywords

community participationenvironmental modificationshome modificationsfall prevention

Outcome Measures

Primary Outcomes (6)

  • 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)

    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

Secondary Outcomes (3)

  • Fall Prevention Strategy Survey (FPSS)

    Baseline and 6-month follow-up

  • Participation Scale

    Baseline and 6-month follow-up

  • Fall Rate

    6 months

Study Arms (2)

REBIL- Intervention arm

EXPERIMENTAL

Participants in this arm will receive the Removing Environmental Barriers to Independent Living (REBIL) intervention.

Behavioral: Removing Environmental Barriers to Independent Living (REBIL)

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.

Behavioral: Waitlist Attentional Control

Interventions

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.

REBIL- Intervention arm

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.

Waitlist Attentional control

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently institutionalized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • 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.

    PMID: 38529197BACKGROUND

Results Point of Contact

Title
Dr. Susy Stark
Organization
Washington University in St. Louis

Study Officials

  • Susan Stark, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel-group, randomized control, participants in the waitlist control group will receive the intervention after 6-month follow up is completed
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2020

First Posted

October 19, 2020

Study Start

November 4, 2020

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

August 27, 2025

Results First Posted

November 18, 2024

Record last verified: 2025-08

Locations