Primary Care Screening and Intervention for Patients With Dementia and Caregivers

NCT07758738 | Not Yet Recruiting DMC

• 2 other identifiers: 24-090279194R33AG079012
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the impact of screening for elder neglect in older adults with dementia in primary care settings and the impact of an intervention for caregivers of older adults with dementia. The hypothesis of the study are:

• Neglect screening in primary care will have a positive impact on outcomes including a decrease in presence of neglect at 6 months and other patient and caregiver outcomes
• Neglect screening paired with a caregiving intervention will have a greater impact on these outcomes than screening alone Researchers will compare three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program, compared to standard care. Participants will be asked to:
• attend primary care clinic visits
• complete questionnaires
• participate in the intervention
• participate in a semi-structured interview

Conditions

Dementia; Elder Abuse; Elder Mistreatment

Outcome Measures

Primary Outcomes (1)

• Percent change in number of participants with the presence of neglect determined by the Vulnerable Elder Protection Team (VEPT) from baseline at 6 months

  Caregiver abuse screen is a yes/no 8-question survey that asks about high stress and tendencies that could lead to future abuse. More "yes" answers indicate higher likelihood of current abuse and neglect, and future risk. The PCP Neglect Screening Questionnaire asks primary care providers for concern for caregiver neglect and level of concern using a 5-point scale. Higher scores indicate increased concern. Provider Observations survey asks for the primary care provider's subjective observations on the older adult's physical health. Electronic Health Record Data Elements survey extracts information from medical charts for hemoglobin, creatinine, and blood urea nitrogen lab results. Information from these surveys are used by the VEPT Expert Panel to determine presence of neglect.

  Baseline; 6 months

Secondary Outcomes (11)

• Change in severity of neglect determined by the Vulnerable Elder Protection Team (VEPT) using the Health-Related Severity in Elder Neglect Scale from baseline at 6 months

  Baseline; 6 months

• Mean change in score for caregiver burden from baseline at 6 months.

  Baseline; 6 month

• Mean change in score of caregiver quality of life from baseline at 6 months

  Baseline; 6 month

• Mean change in score of older adult quality of life from baseline at 6 months

  Baseline; 6 month

• Mean change in score of caregiver preparedness from baseline at 6 months

  Baseline; 6 month

Study Arms (3)

Screening and Intervention

EXPERIMENTAL

Behavioral: SIRENS application; Other: SIRENS screening

Screening only

ACTIVE COMPARATOR

Other: SIRENS screening

Usual care

NO INTERVENTION

Interventions

SIRENS application BEHAVIORAL

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.

Screening and Intervention

SIRENS screening OTHER

The SIRENS screening tool is a novel, easy-to-use, brief screening tool to identify elder neglect in primary care settings.

Screening and Intervention; Screening only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Not a PCP of older adults with dementia who may be at risk of being neglected.
• Aged ≥ 60 years
• Community-dwelling
• Patient of WCM/NYP
• Has diagnosis of dementia (based on medical records prior to enrollment)
• Requires assistance with at least 1 ADL
• Able to travel to a WCM/NYP clinic for study activities
• Has informal (either unpaid or CDPAP) caregiver who provides ≥8 hours weekly
• Not already known to be experiencing neglect from caregiver
• In hospice
• Decision has already been made to re-locate to an institution (including long-term care skilled nursing facilities)
• Age ≥ 21 years
• Living with or near the older adult
• Self-identifies as a caregiver for the older adult
• Provides ≥ 8 hours per week of direct care (may include logistics, oversight, observation, as well as hands-on care, but must include at least some in-person assistance)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tony Rosen, MD

  Weill Cornell Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Park

CONTACT

6469627141; sep4008@med.cornell.edu

Chelsie Burchett, PhD

CONTACT

cob2014@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data from research projects will be made available no later than acceptance of publication of the main findings from the final data set. There is no end date to access the data from the research projects.
• Access Criteria: The investigators agree to share the data with researchers working under an institution with Federal Wide Assurance who agree to a data sharing agreement that stipulates protection of participant privacy and data confidentiality, acknowledgement of SIRENS, that the data will be used for research purposes only, and that the data will not be transferred to other users. The computerized data will include raw data, derived variables, all necessary documentation as described in the National Archive of Computerized Data on Aging depositor agreement. All data will be de-identified. The investigators will follow the guides published by the US Department of Health and Human Services in this respect. Each data set will include data documentation to ensure that others can use the data set and to minimize confusion. Information about where and how to locate and access the data will be available in any publications and presentations authored by SIRENS investigators.

Locations

US (1)