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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG057389 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Cornell University | OTHER |
| Weill Medical College of Cornell University | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-REM training | Experimental | 3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment |
|
| Usual Care | No Intervention | Usual care arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-REM training | Other | three training modules for front-line long-term care staff to aid in recognition, management and reporting of R-REM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Falls, Accidents, and Injuries | Impact on falls, accidents, and injuries as measured by incident reports | Six months before baseline through twelve month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 6- and 12- month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Pre and post training evaluation: Immediately before and immediately after training |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne A Teresi, PhD, EdD | Research Division, Hebrew Home at Riverdale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebrew Home at Riverdale | The Bronx | New York | 10471 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41511825 | Derived | Teresi JA, Silver S, Boratgis GD, Schultz L, Meador R, Kong J, Eimicke JP, Lachs MS, Pillemer KA. A Staff Intervention Targeting Resident-to-Resident Aggression in Assisted Living: A Cluster-Randomized Trial. J Am Geriatr Soc. 2026 Mar;74(3):695-704. doi: 10.1111/jgs.70268. Epub 2026 Jan 9. | |
| 32787944 | Derived | Teresi JA, Silver S, Ramirez M, Kong J, Eimicke JP, Boratgis GD, Meador R, Schultz L, Lachs MS, Pillemer KA. Resident-to-resident elder mistreatment (R-REM) intervention for direct care staff in assisted living residences: study protocol for a cluster randomized controlled trial. Trials. 2020 Aug 12;21(1):710. doi: 10.1186/s13063-020-04580-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Usual Care | Usual care arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 990 is not the correct total number of participants. It is 930. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Falls, Accidents, and Injuries | Impact on falls, accidents, and injuries as measured by incident reports | Analyses were intent to treat. All those randomized were included. | Posted | Number | participants | Six months before baseline through twelve month follow-up |
|
1 year
Using the definitions from clinicaltrials.gov, the DSMB reviewed all events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R-REM Training | 3 module training for frontline staff in assisted living facilities related to recognizing and management of resident-to-resident elder mistreatment |
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The pandemic may have affected the observed affect and behavior results which may have been impacted by missing data. During the pandemic there was more social isolation, impacting quality-of-life outcomes. There were several limitations to this study, most notably the large amount of missing data observed at the final wave in part because of COVID, affected testing the third study aim. To mitigate this loss, several statistical methods were used to examine missing data due to COVID.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeanne Teresi, EdD, PhD | Columbia University in the City of New York | 212-305-9379 | jat61@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2020 | Feb 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 23, 2021 | Feb 4, 2025 | ICF_001.pdf |
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Research Assistants
| 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) |
| baseline through 1-year follow-up |
| 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) | Administered immediately before and immediately after training was provided |
| Withdrawal by Subject |
|
| Usual Care |
Usual care arm. Assisted Living facilities assigned to Usual Care. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 990 is not the correct total number of participants. The total number of participants is 930. | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | 990 is not the correct total number of participants. The correct total number of participants is 930. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | 990 is not the correct total number of participants. The total number of participants is 930. | Number | Participant |
|
|
|
|
| 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). | The FTQ was collected only on the subset of participants who were capable of response | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6- and 12- month follow-up |
|
|
|
| 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) | 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). | Posted | Mean | Standard Deviation | score on a scale | Pre and post training evaluation: Immediately before and immediately after training |
|
|
|
|
| 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) | Nursing home staff informants. | Posted | Count of Participants | Participants | baseline through 1-year follow-up |
|
|
|
|
| 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) | 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). | Posted | Mean | Standard Deviation | score on a scale | Administered immediately before and immediately after training was provided |
|
|
|
|
| 83 |
| 495 |
| 0 |
| 495 |
| 0 |
| 495 |
| EG001 | Usual Care | Usual care arm | 78 | 435 | 0 | 435 | 0 | 435 |
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| 12-month follow-up |
|
| Estimated log mean |
| -4.0168 |
| 2-Sided |
| 95 |
| -5.5827 |
| -2.4509 |
| Superiority |