Risk Screening & Primary Prevention of Elder Abuse in People Living With Dementia (WECARE)

The goal of this clinical trial is to test a risk assessment screening and intervention for caregivers of people with dementia. The main questions it aims to answer are:

1. What are the harms and benefits of administering the elder abuse risk assessment screening?
2. What are the harms and benefits of administering the caregiver intervention?

Researchers will compare participants who receive the screening and caregiver intervention to a group who does not receive the caregiver intervention and a group who receives neither the screening or the caregiver intervention to answer these questions.

Participants will:

• Complete two surveys, three months apart
• Complete a 5-item screening tool, if assigned to one of the screening groups
• Complete a 3-session caregiver intervention, if assigned to that group

Study Overview

• Status: Suspended
• Conditions: Elder Abuse; Caregiver Wellbeing; Caregivers of Alzheimer's Disease or Memory Problem Patients
• Intervention / Treatment: Behavioral: Risk Assessment Screening; Behavioral: Coach and Website Intervention

Detailed Description

This study aims to address the issue of elder mistreatment which affects one in ten older adults, and is particularly prevalent among those with dementia, where rates can reach 50%. In this randomized study, caregivers are assigned to different study groups so researchers can evaluate outcomes across varying levels of support. The project examines how structured assessment and caregiver-focused education influence caregiver stress, decision-making, and overall care dynamics, with the broader aim of informing scalable prevention strategies within primary care systems

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90003
      • Keck Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years old or older
• Speak English or Spanish
• Caregiver for a person with Alzheimer's Disease or another type of dementia
• Provide substantial care for this person, defined as assisting with at least one activity of daily living or two instrumental activities of daily living
• See this person at least twice a week
• Have access to the internet

Exclusion Criteria:

• Under 18 years old
• Speak language besides English or Spanish
• Caregiver for person who does not have dementia
• Do not provide substantial care for this person
• Primary relationship between caregiver and person with dementia is that of a professional paid caregiver
• Enrolled in another caregiver study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will receive no intervention, only the two study surveys.
Experimental: Risk Assessment Screening Only; Participants will complete the risk assessment screening along with the two study surveys.	Behavioral: Risk Assessment Screening; A five question tool that can be delivered verbally or through written self-administration.
Experimental: Risk Assessment Screening and Coach Intervention; Participants will complete the risk assessment screening, three coach sessions, intervention website, and the two study surveys.	Behavioral: Risk Assessment Screening; A five question tool that can be delivered verbally or through written self-administration.; Behavioral: Coach and Website Intervention; A three-session community health worker intervention, including a caregiver information website.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Depression Symptoms	Measured through Patient Health Questionnaire-8 score (0-24) .	Enrollment to three months
Caregiver Anxiety Symptoms	Measured by Generalized Anxiety Disorder-7 screening tool score (0-21) .	Enrollment to three months
Caregiver Burden	Measured by Zarit Burden Interview-6 scores (6-24)	Enrollment to three months
Caregiver Stress About Care Receiver Behavioral Symptoms	Measured by Neuropsychiatric Inventory Questionnaire scores (0-60)	Enrollment to three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elder Mistreatment	Measured using combined and modified Geriatric Mistreatment Scale and Older Adult Conflict Scale (0-19)	Enrollment to three months
Healthcare Use of Person Living with Demenita	Count of each emergency department, hospitalization, and outpatient medical visits.	Enrollment to three months
Dementia Knowledge	Measured using Dementia Attitudes Scale scores (0-36)	Enrollment to three months
Caregiver Self Efficacy	Measured using Self-Efficacy for Caregiving scores (8-40)	Enrollment to three months
Resilience	Measured using modified Brief Resilience Scale scores (6-24)	Enrollment to three months
Elder Abuse Knowledge	Measured using survey questions from previous UK study, with summary scores ranging from 15 to 75 (higher numbers indicating higher understanding of elder abuse).	Enrollment to three months
Stress	Measured using the Perceived Stress Scale scores (0-40)	Enrollment to three months
Emotional Regulation	Measured using modified Difficulties in Emotion Regulation Scale (4-16)	Enrollment to three months
Anger	Measured using the Dimensions of Anger Reactions scale (5-25)	Enrollment to three months
Hopelessness	Measured using modified Beck Hopelessness Inventory scores (7-28)	Enrollment to three months
Social Support	Measured using Duke/UNC Functional Social Support Questionnaire scores (8-40)	Enrollment to three months
Coping	Measured using count of adaptive (0-18) and maladaptive (0-4) coping methods on novel measure	Enrollment to three months
Positive Aspects of Caregiving	Measured using Positive Aspects of Caregiving Scale scores (6-24)	Enrollment to three months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Bonnie Olsen, PhD, University of Southern California; Principal Investigator: Laura Mosqueda, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dementia care; elder mistreatment; caregiver wellness
• Other Study ID Numbers: R33AG078475 (U.S. NIH Grant/Contract); 4R33AG078475-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No