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Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living

Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03383289
Enrollment
930
Registered
2017-12-26
Start date
2018-06-22
Completion date
2023-06-05
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assisted Living, Resident to Resident Elder Mistreatment

Brief summary

Resident-to-resident elder mistreatment (R-REM) is a significant problem in long-term services and support settings (LTSS), and likely to cause physical and or psychological distress. The proposed project tests an intervention developed for use by LTSS staff. As such, it represents an important step in the process of developing approaches for ameliorating and preventing R-REM in assisted living residences which house residents with dementia and related behavioral disorders, and is thus likely to have significant public health impact.

Interventions

OTHERR-REM training

three training modules for front-line long-term care staff to aid in recognition, management and reporting of R-REM

Sponsors

Cornell University
CollaboratorOTHER
Weill Medical College of Cornell University
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Hebrew Home at Riverdale
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Research Assistants

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* all long term residents residing at each facility at baseline, for those unable to consent, proxy consent will be sought

Exclusion criteria

* residents receiving hospice care, * facilities will have the option to exclude individuals for selected reasons, (e.g., severe psychosis)

Design outcomes

Primary

MeasureTime frameDescription
Falls, Accidents, and InjuriesSix months before baseline through twelve month follow-upImpact on falls, accidents, and injuries as measured by incident reports

Secondary

MeasureTime frameDescription
AffectBaseline, 6- and 12- month follow-upImpact 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).

Other

MeasureTime frameDescription
Staff Knowledge Module 1Pre and post training evaluation: Immediately before and immediately after trainingModule 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)
Staff Recognition, Reporting and Care Planning of Resident-to-resident Elder Mistreatment Eventsbaseline through 1-year follow-upStatistical 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)
Staff Knowledge Module 2Administered immediately before and immediately after training was providedModule 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)

Countries

United States

Participant flow

Participants by arm

ArmCount
R-REM Training Intervention 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
495
Usual Care
Usual care arm. Assisted Living facilities assigned to Usual Care.
435
Total930

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath8378
Overall Studydischarge from facility8484
Overall StudyWithdrawal by Subject41

Baseline characteristics

CharacteristicR-REM Training Intervention to Improve Recognition and ReportingTotalUsual Care
Age, Continuous87.68 years
STANDARD_DEVIATION 6.92
88.00 years
STANDARD_DEVIATION 7.21
88.36 years
STANDARD_DEVIATION 7.52
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants9 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
363 Participants683 Participants320 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
130 Participants238 Participants108 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants12 Participants7 Participants
Race (NIH/OMB)
Black or African American
3 Participants11 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants13 Participants2 Participants
Race (NIH/OMB)
White
476 Participants894 Participants418 Participants
Region of Enrollment
United States
495 Participant930 Participant435 Participant
Sex: Female, Male
Female
392 Participants738 Participants346 Participants
Sex: Female, Male
Male
103 Participants192 Participants89 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
83 / 49578 / 435
other
Total, other adverse events
0 / 4950 / 435
serious
Total, serious adverse events
0 / 4950 / 435

Outcome results

Primary

Falls, Accidents, and Injuries

Impact on falls, accidents, and injuries as measured by incident reports

Time frame: Six months before baseline through twelve month follow-up

Population: Analyses were intent to treat. All those randomized were included.

ArmMeasureValue (NUMBER)
R-REM Training to Improve Recognition and ReportingFalls, Accidents, and Injuries141 participants
Usual CareFalls, Accidents, and Injuries115 participants
p-value: 0.417Mixed Models Analysis
Secondary

Affect

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).

Time frame: Baseline, 6- and 12- month follow-up

Population: The FTQ was collected only on the subset of participants who were capable of response

ArmMeasureGroupValue (MEAN)Dispersion
R-REM Training to Improve Recognition and ReportingAffectBaseline6.29 score on a scaleStandard Deviation 5.16
R-REM Training to Improve Recognition and ReportingAffect6-month follow up6.37 score on a scaleStandard Deviation 5.92
R-REM Training to Improve Recognition and ReportingAffect12-month follow-up5.30 score on a scaleStandard Deviation 4.1
Usual CareAffectBaseline6.65 score on a scaleStandard Deviation 4.79
Usual CareAffect6-month follow up6.44 score on a scaleStandard Deviation 4.95
Usual CareAffect12-month follow-up6.11 score on a scaleStandard Deviation 4.47
Other Pre-specified

Staff Knowledge Module 1

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)

Time frame: Pre and post training evaluation: Immediately before and immediately after training

Population: 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).

ArmMeasureValue (MEAN)Dispersion
R-REM Training to Improve Recognition and ReportingStaff Knowledge Module 16.17 score on a scaleStandard Deviation 1.97
Usual CareStaff Knowledge Module 17.53 score on a scaleStandard Deviation 1.95
Comparison: Analysis of adjusted mean differences using a paired t test procedurep-value: <0.00195% CI: [-1.708, -0.998]paired t test
Other Pre-specified

Staff Knowledge Module 2

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)

Time frame: Administered immediately before and immediately after training was provided

Population: 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).

ArmMeasureValue (MEAN)Dispersion
R-REM Training to Improve Recognition and ReportingStaff Knowledge Module 27.59 score on a scaleStandard Deviation 2
Usual CareStaff Knowledge Module 28.04 score on a scaleStandard Deviation 1.52
p-value: 0.00595% CI: [-0.774, -0.138]paired t test
Other Pre-specified

Staff Recognition, Reporting and Care Planning of Resident-to-resident Elder Mistreatment Events

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)

Time frame: baseline through 1-year follow-up

Population: Nursing home staff informants.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
R-REM Training to Improve Recognition and ReportingStaff Recognition, Reporting and Care Planning of Resident-to-resident Elder Mistreatment Events478 Participants
Usual CareStaff Recognition, Reporting and Care Planning of Resident-to-resident Elder Mistreatment Events415 Participants
p-value: 0.006495% CI: [0.1797, 1.0931]Poisson regression
p-value: 0.00195% CI: [-5.5827, -2.4509]Poisson regression

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026