DementiaSIRENSNCT07758738
Primary Care Screening and Intervention for Patients With Dementia and Caregivers
A study testing SIRENS application and SIRENS screening in people with Dementia and Elder Abuse, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Elder Abuse, Elder Mistreatment
- What is being tested?
- SIRENS application and SIRENS screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chelsie Burchett, PhD contact
United States1 site
Weill Cornell Medicine
New York, New York, 10065
Sophie Park, sep4008@med.cornell.edu
About this study
Official title: Primary Care Screening and Intervention for Caregiving Assessment and Support for Patients With Dementia: Randomized Controlled Trial
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:
Read more
- 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
- Being tested
- SIRENS application, SIRENS screening
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRENS applicationBehavioural
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 screeningOther
The SIRENS screening tool is a novel, easy-to-use, brief screening tool to identify elder neglect in primary care settings.
| Study group | Role | What they receive |
|---|---|---|
| Screening and Intervention | Experimental | Not described Receives: Behavioral: SIRENS application; Other: SIRENS screening |
| Screening only | Active comparator | Not described Receives: Other: SIRENS screening |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline; 6 months
Mean change in score for caregiver burden from baseline at 6 months.
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.
Measured: Baseline; 6 month
Mean change in score of caregiver quality of life from baseline at 6 months
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.
Measured: Baseline; 6 month
Mean change in score of older adult quality of life from baseline at 6 months
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.
Measured: Baseline; 6 month
Mean change in score of caregiver preparedness from baseline at 6 months
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.
Measured: Baseline; 6 month
Mean change in score of caregiving self-efficacy from baseline at 6 months
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.
Measured: Baseline; 6 month
Mean change in score of caregiver depression from baseline at 6 months
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.
Measured: Baseline; 6 month
Number of heath outcomes determined by medical chart review
Number of each health outcome such as deaths, hospitalizations and use of medical services. Additional health-related outcomes will be included as identified.
Measured: 6 month
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
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.
Measured: Baseline; 6 month
Number of individual actions taken after positive neglect screen determined by medical chart review
Number of each individual action taken after positive neglect screen. Actions will be included as identified.
Measured: Baseline; 6 month
Change in technology acceptance score from post-intervention at 6 months
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.
Measured: Post-intervention (5 week); 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 774 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Tony Rosen, MD, Principal investigator, Weill Cornell Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758738
- Sponsor's protocol ID
- 24-09027919
- Other IDs
- 4R33AG079012
- Acronym
- SIRENS
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich SIRENS database by the larger research community as this will further the impact of SIRENS and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Screening and Intervention for Caregiving Assessment and Support for Patients With Dementia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07758738
- Acronym / sponsor ID
- SIRENS / 24-09027919
- Conditions
- Dementia, Elder Abuse, Elder Mistreatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 774 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Aug 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 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening and Intervention | Experimental | Behavioral: SIRENS application, Other: SIRENS screening |
| Screening only | Active comparator | Other: SIRENS screening |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SIRENS applicationThe 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. | Behavioural | Screening and Intervention |
| SIRENS screeningThe SIRENS screening tool is a novel, easy-to-use, brief screening tool to identify elder neglect in primary care settings. | Other | Screening and Intervention, Screening only |
Primary outcome
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.
11 secondary outcomes
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
Mean change in score for caregiver burden from baseline at 6 months.
Time frame: Baseline; 6 month
Mean change in score of caregiver quality of life from baseline at 6 months
Time frame: Baseline; 6 month
Mean change in score of older adult quality of life from baseline at 6 months
Time frame: Baseline; 6 month
Mean change in score of caregiver preparedness from baseline at 6 months
Time frame: Baseline; 6 month
Mean change in score of caregiving self-efficacy from baseline at 6 months
Time frame: Baseline; 6 month
Mean change in score of caregiver depression from baseline at 6 months
Time frame: Baseline; 6 month
Number of heath outcomes determined by medical chart review
Time frame: 6 month
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
Number of individual actions taken after positive neglect screen determined by medical chart review
Time frame: Baseline; 6 month
Change in technology acceptance score from post-intervention at 6 months
Time frame: Post-intervention (5 week); 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich SIRENS database by the larger research community as this will further the impact of SIRENS and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
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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.
Chelsie Burchett, PhD contact
Tony Rosen, MD principal investigator
Weill Cornell Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIRENS application and SIRENS screening in people with Dementia and Elder Abuse, run by Weill Medical College of Cornell University 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?
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: opening soon, as of the sponsor's last update on 11 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Park (6469627141, sep4008@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 11 Aug 2026.