- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383289
Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living
March 28, 2025 updated by: Hebrew Home at Riverdale
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
930
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Bronx, New York, United States, 10471
- Hebrew Home at Riverdale
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: R-REM training
3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment
|
three training modules for front-line long-term care staff to aid in recognition, management and reporting of R-REM
|
|
No Intervention: Usual Care
Usual care arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls, Accidents, and Injuries
Time Frame: Six months before baseline through twelve month follow-up
|
Impact on falls, accidents, and injuries as measured by incident reports
|
Six months before baseline through twelve month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affect
Time Frame: Baseline, 6- and 12- month follow-up
|
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).
|
Baseline, 6- and 12- month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Staff Knowledge Module 1
Time Frame: Pre and post training evaluation: Immediately before and immediately after training
|
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)
|
Pre and post training evaluation: Immediately before and immediately after training
|
|
Staff Recognition, Reporting and Care Planning of Resident-to-resident Elder Mistreatment Events
Time Frame: baseline through 1-year follow-up
|
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)
|
baseline through 1-year follow-up
|
|
Staff Knowledge Module 2
Time Frame: Administered immediately before and immediately after training was provided
|
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)
|
Administered immediately before and immediately after training was provided
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeanne A Teresi, PhD, EdD, Research Division, Hebrew Home at Riverdale
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2018
Primary Completion (Actual)
June 5, 2023
Study Completion (Actual)
June 5, 2023
Study Registration Dates
First Submitted
December 8, 2017
First Submitted That Met QC Criteria
December 22, 2017
First Posted (Actual)
December 26, 2017
Study Record Updates
Last Update Posted (Actual)
March 30, 2025
Last Update Submitted That Met QC Criteria
March 28, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 952
- 5R01AG057389 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
To be determined
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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