Trial Outcomes & Findings for Enhanced Medical Rehabilitation in Older Adults (NCT NCT02114879)
NCT ID: NCT02114879
Last Updated: 2020-07-07
Results Overview
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
229 participants
Primary outcome timeframe
Baseline and Discharge, an average of 24 days.
Results posted on
2020-07-07
Participant Flow
Participants were recruited from 2 skilled nursing facilities in the St. Louis, Missouri metropolitan area from July 29, 2014 through March 22, 2018.
Participant milestones
| Measure |
Standard of Care Rehabilitation
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
114
|
|
Overall Study
COMPLETED
|
96
|
90
|
|
Overall Study
NOT COMPLETED
|
19
|
24
|
Reasons for withdrawal
| Measure |
Standard of Care Rehabilitation
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
5
|
|
Overall Study
Death
|
6
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Enhanced Medical Rehabilitation in Older Adults
Baseline characteristics by cohort
| Measure |
Standard of Care Rehabilitation
n=115 Participants
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
n=114 Participants
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Impairment Type
Heart
|
29 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Impairment Type
Respiratory
|
18 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Age, Continuous
|
79.2 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
79.5 years
STANDARD_DEVIATION 8.2 • n=107 Participants
|
79.3 years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Impairment Type
Musculoskeletal/Integument
|
44 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Impairment Type
Renal
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Impairment Type
Neurologic
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Impairment Type
Other/Unknown
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
MADRS Score
|
8.4 units on a scale
STANDARD_DEVIATION 8.0 • n=99 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 7.6 • n=107 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Short Blessed Test Score
|
3.8 units on a scale
STANDARD_DEVIATION 3.2 • n=99 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 3.6 • n=107 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 3.4 • n=206 Participants
|
|
Barthel Index Total Score (Premorbid)
|
95.1 units on a scale
STANDARD_DEVIATION 9.0 • n=99 Participants
|
96.1 units on a scale
STANDARD_DEVIATION 6.9 • n=107 Participants
|
95.6 units on a scale
STANDARD_DEVIATION 8.1 • n=206 Participants
|
|
Barthel Index Total Score (Admission)
|
34.7 units on a scale
STANDARD_DEVIATION 12.8 • n=99 Participants
|
32.3 units on a scale
STANDARD_DEVIATION 13.1 • n=107 Participants
|
33.5 units on a scale
STANDARD_DEVIATION 13.0 • n=206 Participants
|
|
CIRS-G Score
|
17.1 units on a scale
STANDARD_DEVIATION 5.4 • n=99 Participants
|
16.8 units on a scale
STANDARD_DEVIATION 5.0 • n=107 Participants
|
16.9 units on a scale
STANDARD_DEVIATION 5.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Discharge, an average of 24 days.Population: One Standard of Care participant did not have a baseline Barthel completed. Otherwise, all other 228 participants were included in the analysis.
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
Outcome measures
| Measure |
Standard of Care Rehabilitation
n=114 Participants
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
n=114 Participants
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
Change in Barthel Index Score
|
28.48 score on a scale
Standard Error 1.68
|
34.92 score on a scale
Standard Error 1.66
|
SECONDARY outcome
Timeframe: Discharge, an average of 24 days after baseline.Population: All participants with a gait speed at discharge were included in the analysis.
Meters walked per second.
Outcome measures
| Measure |
Standard of Care Rehabilitation
n=94 Participants
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
n=105 Participants
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
Gait Speed (Determined by 4 or 10 Meter Walk Test)
|
0.45 meters per second
Interval 0.13 to 0.63
|
0.35 meters per second
Interval 0.05 to 0.52
|
SECONDARY outcome
Timeframe: Discharge, an average of 24 days after baseline.Population: All participants able to perform a 6-minute walk at discharge were included in the analysis.
Feet walked during 6 minute interval.
Outcome measures
| Measure |
Standard of Care Rehabilitation
n=93 Participants
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
n=104 Participants
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
Distance Ambulated in 6-Minute Walk Test
|
210 feet
Interval 53.0 to 354.5
|
170 feet
Interval 41.75 to 364.5
|
SECONDARY outcome
Timeframe: 30, 60, and 90 Days Post Admission to the SNFPopulation: Any participant with data at either 30 days, 60 days, 90 days, or at discharge were included in the analyses.
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. Conducted as a self-report at timepoints where patient was not in an institutional setting.
Outcome measures
| Measure |
Standard of Care Rehabilitation
n=114 Participants
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
n=114 Participants
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
Self-reported Barthel Index
Day 30
|
78.95 score on a scale
Standard Error 2.08
|
78.79 score on a scale
Standard Error 2.08
|
|
Self-reported Barthel Index
Day 60
|
85.01 score on a scale
Standard Error 1.94
|
84.27 score on a scale
Standard Error 1.99
|
|
Self-reported Barthel Index
Day 90
|
84.67 score on a scale
Standard Error 2.16
|
83.65 score on a scale
Standard Error 2.20
|
SECONDARY outcome
Timeframe: Discharge, an average of 24 days after baseline.Population: Any participant with a discharge disposition of either 'to home' or 'to institution' were included in the analysis.
Number of participants discharged from skilled nursing facility to home
Outcome measures
| Measure |
Standard of Care Rehabilitation
n=110 Participants
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
n=110 Participants
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
Discharge Disposition
|
89 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Days 30, 60, and 90 post admission to a SNF as well as at DischargePopulation: Any participant with at least one re-hospitalization at day 30, day 60, day 90 or at discharge was included in the analysis.
Assesses whether the participant was readmitted to the hospital.
Outcome measures
| Measure |
Standard of Care Rehabilitation
n=110 Participants
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
n=111 Participants
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
Rehospitalizations
|
43 Participants
|
42 Participants
|
Adverse Events
Standard of Care Rehabilitation
Serious events: 6 serious events
Other events: 0 other events
Deaths: 6 deaths
Enhanced Medical Rehabilitation
Serious events: 11 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Standard of Care Rehabilitation
n=115 participants at risk
Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention.
|
Enhanced Medical Rehabilitation
n=114 participants at risk
Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
|
|---|---|---|
|
General disorders
all cause mortality
|
5.2%
6/115 • Number of events 6 • 90 days
All cause mortality was tracked for 90 days.
|
9.6%
11/114 • Number of events 11 • 90 days
All cause mortality was tracked for 90 days.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place