SIRENS for Elder Abuse and Dementia

(SIRENS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-fluent English, Hired caregiver, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a new tool and support program to help doctors identify signs of neglect in older adults with dementia. It will test a technology-based intervention called SIRENS, designed for caregivers, offering expert-reviewed information and resources to support their caregiving. The trial will compare the effectiveness of the screening tool alone and with the support program against standard care. Primary caregivers who provide at least 8 hours of care per week to older adults with dementia are good candidates for this trial.

As an unphased trial, participants can contribute to groundbreaking research that may improve caregiving for dementia patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this screening tool and support program are safe for older adults with dementia?

Research shows that the SIRENS program, which supports caregivers of people with dementia, provides helpful information and resources. No specific data indicates any safety issues or negative effects from this program. As a technology-based tool, it is unlikely to cause physical harm.

Programs like SIRENS often help caregivers better manage their loved ones' needs, reducing stress and leading to better outcomes. In other studies of similar support programs, caregivers reported feeling more capable and less stressed. This suggests that the SIRENS program could also be safe and helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SIRENS intervention is unique because it offers caregivers of those with dementia a technology-based tool that combines expert-reviewed information with practical resources. Unlike traditional support groups or educational sessions, SIRENS provides take-home messages that summarize key points and a goal-setting feature that encourages caregivers to establish small, actionable goals. Researchers are excited because this approach empowers caregivers with tailored support and the flexibility to access help at their convenience, potentially improving both caregiver well-being and patient care outcomes.

What evidence suggests that the SIRENS intervention is effective for elder abuse and dementia?

Research has shown that older adults with dementia are more likely to experience elder abuse, which often goes unnoticed or unreported. In this trial, the SIRENS program aims to tackle this issue by providing caregivers with easy access to expert-reviewed information and resources through a mobile app. Although one study found no significant change in abuse scores with similar programs, SIRENS focuses on improving support and education for caregivers. This approach might lead to better outcomes by helping caregivers set small, practical goals, potentially reducing neglect. Overall, the goal is to empower caregivers and enhance their ability to care for people with dementia effectively. ^{6 7 8 9 10}

Who Is on the Research Team?

Sara J Czaja, PhD

Principal Investigator

Weill Cornell Medical College of Cornell University

Anthony Rosen, MD

Principal Investigator

Weill Cornell Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for older adults showing signs of neglect with dementia. Participants must be able to visit the doctor for screening and use an Android phone if they're in the group that gets the support program.

Inclusion Criteria

Can read and speak English at a 6th grade level or above

I am the main caregiver for an elderly person.

Not blind or deaf

Exclusion Criteria

Hired caregiver

Provides care for a patient in hospice care

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the SIRENS technology-based intervention designed for caregivers of those with dementia

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for system feasibility, acceptability, and usability, as well as caregiving self-efficacy, depression, burden, quality of life, and preparedness

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• SIRENS

Trial Overview The study is testing a new tool called SIRENS designed to help doctors detect elder neglect in patients with dementia, along with a support program accessible via mobile app compared to usual care.

How Is the Trial Designed?

Group I: Experimental: SIRENS Intervention Experimental Treatment 1 Intervention

The SIRENS intervention is a technology intervention designed specifically for caregivers of those with dementia, providing them with easy access to expert-reviewed information and helpful resources. The content includes take-home messages summarizing the main points discussed and a goal-setting feature that encourages the care givers to establish small, actionable goals.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07146581

Technology-Based Intervention Usability and Pilot Testing Elder abuse is common and has serious health consequences but is under-recognized and under-reported. Older adults with dementia are at much higher risk of ...

2. withpower.com withpower.com/trial/phase-elder-neglect-7-2025-9b9df

SIRENS for Elder Abuse and Dementia · Info for Participants SIRENS for Elder Abuse and Dementia ... The SIRENS intervention is a technology intervention designed specifically for caregivers of those with dementia ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11491043/

Effectiveness of interventions to prevent abuse in people ... A study (Afshari et al., 2023), which assessed family carer abuse of people living with dementia, found no statistically significant difference in abuse scores ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0883941724000633

Effectiveness of a health education program for people with ... This study assesses the effectiveness of a health education program on caregiving outcomes for people with dementia and their families.

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.679541/full

The Effectiveness of Psychosocial Interventions for Elder ... This study aims to identify the pooled effect size of prevention and interventions targeted ultimate and intermediate outcomes for elder abuse that occurred in ...

6. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.19087

Beyond flashing lights and sirens: Community paramedicine ... Furthermore, among patients evaluated by the community paramedicine program, those with dementia were more likely to be referred to hospice.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11368620/

Community Paramedicine as Health Safety Nets for Older ... Furthermore, among patients evaluated by the community paramedicine program, those with dementia were more likely to be referred to hospice.

8. hsrd.research.va.gov hsrd.research.va.gov/research/citations/pubbriefs/articles.cfm?RecordID=598

Home Safety Intervention Improves Caregiver Competence for ... Older adults are at increased risk of accidents and injuries in the home compared to the general population, and persons with dementia are at even greater risk ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7533912/

Elder Abuse Assessment Tools and Interventions for use in ... For example, a lower level of depression by family caregivers of people with dementia, stopping the abuse, or progress in knowledge of nurses ...

10. eldermistreatment.usc.edu eldermistreatment.usc.edu/wp-content/uploads/2023/07/NCEA_RB_Dementia_2023.pdf

NCEA Research Brief: Mistreatment of People with Dementia Vulnerabilities associated with dementia expose individuals to an increased risk of abuse and neglect. For PWD with chronic medical conditions and co- ...