Caregivers of Alzheimer's Disease or Memory Problem PatientsWECARENCT07429591
Risk Screening & Primary Prevention of Elder Abuse in People Living With Dementia
A study testing Risk Assessment Screening and Coach and Website Intervention in people with Caregivers of Alzheimer's Disease or Memory Problem Patients and Caregiver Wellbeing, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers of Alzheimer's Disease or Memory Problem Patients, Caregiver Wellbeing, Elder Abuse
- What is being tested?
- Risk Assessment Screening and Coach and Website Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- What are the harms and benefits of administering the elder abuse risk assessment screening?
- What are the harms and benefits of administering the caregiver intervention?
Read more
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
Read the 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
- Conditions
- Caregivers of Alzheimer's Disease or Memory Problem Patients, Caregiver Wellbeing, Elder Abuse
- Being tested
- Risk Assessment Screening, Coach and Website Intervention
- Keywords
- elder mistreatment, caregiver wellness, Dementia care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Assessment ScreeningBehavioural
A five question tool that can be delivered verbally or through written self-administration.
Coach and Website InterventionBehavioural
A three-session community health worker intervention, including a caregiver information website.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will receive no intervention, only the two study surveys. |
| Risk Assessment Screening Only | Experimental | Participants will complete the risk assessment screening along with the two study surveys. Receives: Behavioral: Risk Assessment Screening |
| Risk Assessment Screening and Coach Intervention | Experimental | Participants will complete the risk assessment screening, three coach sessions, intervention website, and the two study surveys. Receives: Behavioral: Risk Assessment Screening; Behavioral: Coach and Website Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Depression Symptoms
Measured through Patient Health Questionnaire-8 score (0-24) .
Measured: Enrollment to three months
Caregiver Anxiety Symptoms
Measured by Generalized Anxiety Disorder-7 screening tool score (0-21) .
Measured: Enrollment to three months
Caregiver Burden
Measured by Zarit Burden Interview-6 scores (6-24)
Measured: Enrollment to three months
Caregiver Stress About Care Receiver Behavioral Symptoms
Measured by Neuropsychiatric Inventory Questionnaire scores (0-60)
Measured: Enrollment to three months
Secondary outcomes (13)
Elder Mistreatment
Measured using combined and modified Geriatric Mistreatment Scale and Older Adult Conflict Scale (0-19)
Measured: Enrollment to three months
Healthcare Use of Person Living with Demenita
Count of each emergency department, hospitalization, and outpatient medical visits.
Measured: Enrollment to three months
Dementia Knowledge
Measured using Dementia Attitudes Scale scores (0-36)
Measured: Enrollment to three months
Caregiver Self Efficacy
Measured using Self-Efficacy for Caregiving scores (8-40)
Measured: Enrollment to three months
Resilience
Measured using modified Brief Resilience Scale scores (6-24)
Measured: 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).
Measured: Enrollment to three months
Stress
Measured using the Perceived Stress Scale scores (0-40)
Measured: Enrollment to three months
Emotional Regulation
Measured using modified Difficulties in Emotion Regulation Scale (4-16)
Measured: Enrollment to three months
Anger
Measured using the Dimensions of Anger Reactions scale (5-25)
Measured: Enrollment to three months
Hopelessness
Measured using modified Beck Hopelessness Inventory scores (7-28)
Measured: Enrollment to three months
Social Support
Measured using Duke/UNC Functional Social Support Questionnaire scores (8-40)
Measured: Enrollment to three months
Coping
Measured using count of adaptive (0-18) and maladaptive (0-4) coping methods on novel measure
Measured: Enrollment to three months
Positive Aspects of Caregiving
Measured using Positive Aspects of Caregiving Scale scores (6-24)
Measured: Enrollment to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Why it stopped: Study paused per IRB request.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregivers of Alzheimer's Disease or Memory Problem PatientsStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Bonnie Olsen, PhD, Principal investigator, University of Southern CaliforniaLaura Mosqueda, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429591
- Sponsor's protocol ID
- R33AG078475
- Other IDs
- 4R33AG078475-03
- Acronym
- WECARE
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Screening & Primary Prevention of Elder Abuse in People Living With Dementia
- ClinicalTrials.gov ID
- NCT07429591
- Acronym / sponsor ID
- WECARE / R33AG078475
- Conditions
- Caregivers of Alzheimer's Disease or Memory Problem Patients, Caregiver Wellbeing, Elder Abuse
- Keywords
- elder mistreatment, caregiver wellness, Dementia care
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study paused per IRB request.
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the harms and benefits of administering the elder abuse risk assessment screening?
- 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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will receive no intervention, only the two study surveys. |
| Risk Assessment Screening Only | Experimental | Behavioral: Risk Assessment ScreeningParticipants will complete the risk assessment screening along with the two study surveys. |
| Risk Assessment Screening and Coach Intervention | Experimental | Behavioral: Risk Assessment Screening, Behavioral: Coach and Website InterventionParticipants will complete the risk assessment screening, three coach sessions, intervention website, and the two study surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Assessment ScreeningA five question tool that can be delivered verbally or through written self-administration. | Behavioural | Risk Assessment Screening Only, Risk Assessment Screening and Coach Intervention |
| Coach and Website InterventionA three-session community health worker intervention, including a caregiver information website. | Behavioural | Risk Assessment Screening and Coach Intervention |
Primary outcome
Caregiver Depression Symptoms
Time frame: Enrollment to three months
Measured through Patient Health Questionnaire-8 score (0-24) .
Caregiver Anxiety Symptoms
Time frame: Enrollment to three months
Measured by Generalized Anxiety Disorder-7 screening tool score (0-21) .
Caregiver Burden
Time frame: Enrollment to three months
Measured by Zarit Burden Interview-6 scores (6-24)
Caregiver Stress About Care Receiver Behavioral Symptoms
Time frame: Enrollment to three months
Measured by Neuropsychiatric Inventory Questionnaire scores (0-60)
13 secondary outcomes
Elder Mistreatment
Time frame: Enrollment to three months
Healthcare Use of Person Living with Demenita
Time frame: Enrollment to three months
Dementia Knowledge
Time frame: Enrollment to three months
Caregiver Self Efficacy
Time frame: Enrollment to three months
Resilience
Time frame: Enrollment to three months
Elder Abuse Knowledge
Time frame: Enrollment to three months
Stress
Time frame: Enrollment to three months
Emotional Regulation
Time frame: Enrollment to three months
Anger
Time frame: Enrollment to three months
Hopelessness
Time frame: Enrollment to three months
Social Support
Time frame: Enrollment to three months
Coping
Time frame: Enrollment to three months
Positive Aspects of Caregiving
Time frame: Enrollment to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Caregivers of Alzheimer's Disease or Memory Problem Patients
Not yet recruiting
Psychological Counseling Program for Alzheimer's Patients' Caregivers
Alzheimer Disease, Caregivers of Alzheimer's Disease or Memory Problem Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Olsen, PhD principal investigator
University of Southern California
Laura Mosqueda, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Assessment Screening and Coach and Website Intervention in people with Caregivers of Alzheimer's Disease or Memory Problem Patients and Caregiver Wellbeing, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Depression Symptoms (time frame: Enrollment to three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.