Trial Outcomes & Findings for Aging With Long Term Physical Disabilities (NCT NCT04589988)
NCT ID: NCT04589988
Last Updated: 2025-08-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline and 6-month follow up
Results posted on
2025-08-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aging With Long Term Physical Disabilities
Baseline characteristics by cohort
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 4.4 • n=99 Participants
|
58.4 years
STANDARD_DEVIATION 5.3 • n=107 Participants
|
57.8 years
STANDARD_DEVIATION 4.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Black/African American
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · White
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
24 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Living situation
Lives with someone
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Living situation
Lives alone
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Receives assistance with daily activities
Yes
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Receives assistance with daily activities
No
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Work status
Working full-time/part-time
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Work status
Disability leave
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Work status
Retired/other
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Use of mobility device
None
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Use of mobility device
Wheelchair
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Use of mobility device
Other device (e.g., cane, walker)
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
PROMIS Depression
|
53.5 T-score
STANDARD_DEVIATION 9.6 • n=99 Participants
|
54.6 T-score
STANDARD_DEVIATION 9.0 • n=107 Participants
|
54.1 T-score
STANDARD_DEVIATION 9.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6-month follow upThe 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.
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
In-Home Occupational Performance Evaluation (I-HOPE) Activity Score
Baseline
|
0.73 score on a scale
Standard Error 0.03
|
0.72 score on a scale
Standard Error 0.03
|
|
In-Home Occupational Performance Evaluation (I-HOPE) Activity Score
6-month follow up
|
0.76 score on a scale
Standard Error 0.03
|
0.69 score on a scale
Standard Error 0.03
|
PRIMARY outcome
Timeframe: Baseline and 6-month follow upThe 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).
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
In-Home Occupational Performance Evaluation (I-HOPE) Performance Score
Baseline
|
2.49 score on a scale
Standard Error 0.15
|
2.52 score on a scale
Standard Error 0.15
|
|
In-Home Occupational Performance Evaluation (I-HOPE) Performance Score
6-month follow up
|
3.23 score on a scale
Standard Error 0.15
|
2.87 score on a scale
Standard Error 0.15
|
PRIMARY outcome
Timeframe: Baseline and 6-month follow upThe 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).
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score
Baseline
|
2.12 score on a scale
Standard Error 0.17
|
2.09 score on a scale
Standard Error 0.18
|
|
In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score
6-month follow-up
|
2.86 score on a scale
Standard Error 0.17
|
2.74 score on a scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Baseline and 6-month follow upThe 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.
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score
Baseline
|
50.28 score on a scale
Standard Error 4.78
|
51.83 score on a scale
Standard Error 4.82
|
|
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
|
27.79 score on a scale
Standard Error 4.82
|
PRIMARY outcome
Timeframe: Baseline and 6-month follow-upThe 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.
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
Reintegration to Normal Living Index (RNLI)
Baseline
|
65.59 score on a scale
Standard Error 3.56
|
66.10 score on a scale
Standard Error 3.72
|
|
Reintegration to Normal Living Index (RNLI)
6-month follow up
|
70.08 score on a scale
Standard Error 3.52
|
68.90 score on a scale
Standard Error 3.72
|
PRIMARY outcome
Timeframe: Baseline and 6-month follow upThe 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.
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
Westmead Home Safety Assessment (WeHSA) Short Form
Baseline
|
10.52 number of fall hazards
Standard Error 1.05
|
9.94 number of fall hazards
Standard Error 1.05
|
|
Westmead Home Safety Assessment (WeHSA) Short Form
6-month follow up
|
7.04 number of fall hazards
Standard Error 1.05
|
6.94 number of fall hazards
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline and 6-month follow-upThe 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.
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
Fall Prevention Strategy Survey (FPSS)
Baseline
|
13.2 score on a scale
Standard Error 0.9
|
13.9 score on a scale
Standard Error 0.9
|
|
Fall Prevention Strategy Survey (FPSS)
6-month follow up
|
16.5 score on a scale
Standard Error 0.9
|
15.2 score on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline and 6-month follow-upThis 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).
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
Participation Scale
Baseline
|
0.54 ratio
Standard Error 0.05
|
0.58 ratio
Standard Error 0.05
|
|
Participation Scale
6-month follow-up
|
0.65 ratio
Standard Error 0.05
|
0.63 ratio
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 6 monthsParticipants 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.
Outcome measures
| Measure |
REBIL- Intervention Arm
n=23 Participants
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.
|
Waitlist Attentional Control
n=24 Participants
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.
|
|---|---|---|
|
Fall Rate
|
15 Rate of falls per 1000 participant days
|
17.6 Rate of falls per 1000 participant days
|
Adverse Events
REBIL- Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Attentional Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place