Trial Outcomes & Findings for Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living (NCT NCT03383289)
NCT ID: NCT03383289
Last Updated: 2025-03-30
Results Overview
Impact on falls, accidents, and injuries as measured by incident reports
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
930 participants
Primary outcome timeframe
Six months before baseline through twelve month follow-up
Results posted on
2025-03-30
Participant Flow
Unit of analysis: Assisted Living Facilities
Participant milestones
| Measure |
R-REM Training to Improve Recognition and Reporting
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment, including the Support, Evaluate, Act, Report, Care plan, and Help to avoid (SEARCH) approach
|
Usual Care
Usual care arm
|
|---|---|---|
|
Overall Study
STARTED
|
495 7
|
435 7
|
|
Overall Study
Study Completion
|
495 7
|
435 7
|
|
Overall Study
COMPLETED
|
324 7
|
272 7
|
|
Overall Study
NOT COMPLETED
|
171 0
|
163 0
|
Reasons for withdrawal
| Measure |
R-REM Training to Improve Recognition and Reporting
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment, including the Support, Evaluate, Act, Report, Care plan, and Help to avoid (SEARCH) approach
|
Usual Care
Usual care arm
|
|---|---|---|
|
Overall Study
Death
|
83
|
78
|
|
Overall Study
discharge from facility
|
84
|
84
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
990 is not the correct total number of participants. It is 930.
Baseline characteristics by cohort
| Measure |
R-REM Training Intervention to Improve Recognition and Reporting
n=495 Participants
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment, including the Support, Evaluate, Act, Report, Care plan, and Help to avoid (SEARCH) approach
|
Usual Care
n=435 Participants
Usual care arm. Assisted Living facilities assigned to Usual Care.
|
Total
n=930 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
87.68 years
STANDARD_DEVIATION 6.92 • n=93 Participants • 990 is not the correct total number of participants. It is 930.
|
88.36 years
STANDARD_DEVIATION 7.52 • n=4 Participants • 990 is not the correct total number of participants. It is 930.
|
88.00 years
STANDARD_DEVIATION 7.21 • n=27 Participants • 990 is not the correct total number of participants. It is 930.
|
|
Sex: Female, Male
Female
|
392 Participants
n=93 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
346 Participants
n=4 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
738 Participants
n=27 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
|
Sex: Female, Male
Male
|
103 Participants
n=93 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
89 Participants
n=4 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
192 Participants
n=27 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
7 Participants
n=4 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
9 Participants
n=27 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
363 Participants
n=93 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
320 Participants
n=4 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
683 Participants
n=27 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
130 Participants
n=93 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
108 Participants
n=4 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
238 Participants
n=27 Participants • 990 is not the correct total number of participants. The correct total number of participants is 930.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
476 Participants
n=93 Participants
|
418 Participants
n=4 Participants
|
894 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
495 Participant
n=93 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
435 Participant
n=4 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
930 Participant
n=27 Participants • 990 is not the correct total number of participants. The total number of participants is 930.
|
PRIMARY outcome
Timeframe: Six months before baseline through twelve month follow-upPopulation: Analyses were intent to treat. All those randomized were included.
Impact on falls, accidents, and injuries as measured by incident reports
Outcome measures
| Measure |
R-REM Training to Improve Recognition and Reporting
n=495 Participants
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment, including the Support, Evaluate, Act, Report, Care plan, and Help to avoid (SEARCH) approach
|
Usual Care
n=435 Participants
Usual care arm
|
|---|---|---|
|
Falls, Accidents, and Injuries
|
141 participants
|
115 participants
|
SECONDARY outcome
Timeframe: Baseline, 6- and 12- month follow-upPopulation: The FTQ was collected only on the subset of participants who were capable of response
Impact on participant affect as measured by the Feeling Tone Questionnaire (FTQ). A 16-item scale with a theoretical range of 0-32. Higher score indicates lower affect (depressed direction).
Outcome measures
| Measure |
R-REM Training to Improve Recognition and Reporting
n=279 Participants
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment, including the Support, Evaluate, Act, Report, Care plan, and Help to avoid (SEARCH) approach
|
Usual Care
n=259 Participants
Usual care arm
|
|---|---|---|
|
Affect
Baseline
|
6.29 score on a scale
Standard Deviation 5.16
|
6.65 score on a scale
Standard Deviation 4.79
|
|
Affect
6-month follow up
|
6.37 score on a scale
Standard Deviation 5.92
|
6.44 score on a scale
Standard Deviation 4.95
|
|
Affect
12-month follow-up
|
5.30 score on a scale
Standard Deviation 4.10
|
6.11 score on a scale
Standard Deviation 4.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre and post training evaluation: Immediately before and immediately after trainingPopulation: Front-line staff in Intervention group nursing homes. Please note that this n differs from the participant n (assisted living residents) described in the flow diagram because this outcome is based on a different sample (staff).
Module 1: Recognizing R-REM 10-item knowledge test related to recognizing resident-to-resident elder mistreatment The potential (theoretical) total score range is 0-10 with a higher score indicating more knowledge (better outcome)
Outcome measures
| Measure |
R-REM Training to Improve Recognition and Reporting
n=211 Participants
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment, including the Support, Evaluate, Act, Report, Care plan, and Help to avoid (SEARCH) approach
|
Usual Care
n=211 Participants
Usual care arm
|
|---|---|---|
|
Staff Knowledge Module 1
|
6.17 score on a scale
Standard Deviation 1.97
|
7.53 score on a scale
Standard Deviation 1.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline through 1-year follow-upPopulation: Nursing home staff informants.
Statistical Analysis 1: Count of participants with events reported by the staff through the informant interview measure Statistical Analysis 2: Count of events reported through the Behavior Recognition Documentation Sheets (BRDS)
Outcome measures
| Measure |
R-REM Training to Improve Recognition and Reporting
n=478 Participants
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment, including the Support, Evaluate, Act, Report, Care plan, and Help to avoid (SEARCH) approach
|
Usual Care
n=415 Participants
Usual care arm
|
|---|---|---|
|
Staff Recognition, Reporting and Care Planning of Resident-to-resident Elder Mistreatment Events
|
478 Participants
|
415 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered immediately before and immediately after training was providedPopulation: Front-line staff in Intervention group nursing homes. Please note that this n differs from the participant n (assisted living residents) described in the flow diagram because this outcome is based on a different sample (staff).
Module 2: Management of R-REM 10-item knowledge tests The potential (theoretical) range is 0-10 with a higher score indicating more knowledge (better outcome)
Outcome measures
| Measure |
R-REM Training to Improve Recognition and Reporting
n=228 Participants
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment, including the Support, Evaluate, Act, Report, Care plan, and Help to avoid (SEARCH) approach
|
Usual Care
n=228 Participants
Usual care arm
|
|---|---|---|
|
Staff Knowledge Module 2
|
7.59 score on a scale
Standard Deviation 2.00
|
8.04 score on a scale
Standard Deviation 1.52
|
Adverse Events
R-REM Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 83 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 78 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeanne Teresi, EdD, PhD
Columbia University in the City of New York
Phone: 212-305-9379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place