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| ID | Type | Description | Link |
|---|---|---|---|
| 4R33AG078475-03 | U.S. NIH Grant/Contract | View source |
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Study paused per IRB request.
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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:
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Risk Assessment Screening and Coach Intervention | Experimental | Participants will complete the risk assessment screening, three coach sessions, intervention website, and the two study surveys. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk Assessment Screening | Behavioral | A five question tool that can be delivered verbally or through written self-administration. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Olsen, PhD | University of Southern California | Principal Investigator |
| Laura Mosqueda, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medicine | Los Angeles | California | 90003 | United States |
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| Coach and Website Intervention | Behavioral | A three-session community health worker intervention, including a caregiver information website. |
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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 |