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NCT Number: NCT07758738

Primary Care Screening and Intervention for Patients With Dementia and Caregivers

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

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location contact

Sophie Park

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Primary care provider Inclusion Criteria • Active PCP who may be a physician or nurse practitioner seeing adult primary care patients with dementia at: Weill Cornell Medicine

Primary care provider Exclusion Criteria

  • Not a PCP of older adults with dementia who may be at risk of being neglected.

Older Adult Inclusion Criteria:

  • 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

Older Adult Exclusion Criteria:

  • In hospice
  • Decision has already been made to re-locate to an institution (including long-term care skilled nursing facilities)

Caregiver Inclusion Criteria:

  • 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)
  • Able to travel to a WCM/NYP clinic for study activities or participate in study activities virtually through Zoom on their personal device
  • Not a professional caregiver, does not receive direct payment in return for care (unless through CDPAP)
  • Can read and speak English at a 6th grade level
  • No active plan to disengage from providing care to older adult within the next year

Caregiver Exclusion Criteria:

  • Unable to read and speak English at a 6th grade level
  • Hired/paid professional caregiver
  • Is blind or deaf
  • Active plan to disengage from providing care to older adult within the next year

Treatment and study plan

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.

SIRENS screening

Other

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

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

    Time frame: Baseline; 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.

Secondary outcomes

  1. 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

    Time frame: Baseline; 6 months

    The VEPT Expert Panel's impression of the change in severity of neglect will be measured by the Health-Related Severity in Elder Neglect Scale. This scale asks providers two yes/no questions whether there is concern for caregiver neglect based on the screening tools and clinical assessment. If yes, their level of concern is asked based on the scale: Not Present; Not Present, Potential Risk; Present, Mild; Present, Moderate; and Present, Severe. There is no numerical or total score.

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

    Time frame: Baseline; 6 month

    Caregiver burden will be assessed in care partner participants using the reliable and valid Caregiver Burden Scale. Response options range from 0= Never to 4= Nearly always. Questions include those asking about relationship with the care recipient and stress. Overall scores range from 0 to 48, with higher scores indicating more caregiver burden.

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

    Time frame: Baseline; 6 month

    Caregiver quality of life will be assessed in care partner participants using the reliable and valid Quality of Life Inventory survey. Questions include those asking about importance (on a 3-point rating scale, higher value indicating more importance) and satisfaction (on a 6-point rating scale, higher value indicating more satisfaction) of life domains. Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine the overall score. Overall scores range from -96 to 96, with higher scores indicating higher quality of life.

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

    Time frame: Baseline; 6 month

    Older adult quality of life will be assessed in patients using the reliable and valid Quality of Life Dementia survey. Questions include those asking about subjective wellbeing using a 5-point rating scale across five domains: self-esteem, positive affect, negative affect, feelings of belonging, sense of aesthetics. Mean scores are computed for each domain, with high scores indicating more satisfaction (negative affect is reverse scored). Domain scores range from 1 to 5, with higher scores indicating higher quality of life. There is no total overall score.

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

    Time frame: Baseline; 6 month

    Caregiver preparedness will be assessed in care partner participants using the Caregiver Preparedness Scale. Response options range from 0= Not at all prepared to 4= Very well prepared. Overall scores range from 0 to 24 with higher scores indicating more feelings of preparedness.

  6. Mean change in score of caregiving self-efficacy from baseline at 6 months

    Time frame: Baseline; 6 month

    Caregiving self-efficacy will be measured in care partner participants by a modified Caregiving Self-Efficacy Scale. Response options range from 0= Can not do at all to 100= Certainly can do. Overall scores range from 0 to 900 with higher scores indicating more confidence.

  7. Mean change in score of caregiver depression from baseline at 6 months

    Time frame: Baseline; 6 month

    Caregiver depression will be assessed in care partner participants using the reliable and valid Center for Epidemiologic Studies Depression Scale. Response options range from 0= Rarely or none of the time to 3= Most or almost none of the time. Overall scores range from 0 to 60 with higher scores indicating greater depressive symptoms.

  8. Number of heath outcomes determined by medical chart review

    Time frame: 6 month

    Number of each health outcome such as deaths, hospitalizations and use of medical services. Additional health-related outcomes will be included as identified.

  9. Count of the primary care provider's impression of the presence of neglect and severity of neglect measured by the Health-Related Severity in Elder Neglect Scale

    Time frame: Baseline; 6 month

    The primary care provider's impression of the presence of neglect and severity of neglect will be measured by the Health-Related Severity in Elder Neglect Scale. This scale asks providers two yes/no questions whether there is concern for caregiver neglect based on the screening tools and clinical assessment. If yes, their level of concern is asked based on the scale: Not Present; Not Present, Potential Risk; Present, Mild; Present, Moderate; and Present, Severe. There is no numerical or total score.

  10. Number of individual actions taken after positive neglect screen determined by medical chart review

    Time frame: Baseline; 6 month

    Number of each individual action taken after positive neglect screen. Actions will be included as identified.

  11. Change in technology acceptance score from post-intervention at 6 months

    Time frame: Post-intervention (5 week); 6 month

    Use of the intervention will be determined by the Technology Acceptance Scale which assesses system acceptance in two dimensions: a Usefulness scale and an affective Satisfying scale. Response options range from -2 to 2. Items 3, 6, and 8 are mirrored and should be scored -2..+2. The Usefulness scale is the sum of item 1 + 3 + 5 + 7 + 9 divided by 5, the Satisfying scale is the sum of items 2, 4, 6, and 8, divided by 4. Each scale has a total score that ranges from -2 to +2, with higher scores indicating more usefulness or satisfaction. The scales are not combined for a total score.

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsie Burchett, PhD

CONTACT

[email protected]

Sophie Park

CONTACT

[email protected]

6469627141

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Primary Care Screening and Intervention for Caregiving Assessment and Support for Patients With Dementia: Randomized Controlled Trial

Acronym: SIRENS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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