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NCT Number: NCT07146581

Technology-Based Intervention Usability and Pilot Testing

This research project has three main goals:

(1) To create a new screening tool that helps primary care doctors spot signs of neglect in older adults with dementia. (2) To design a support program that can be delivered both in person and through a mobile app on Android phones. (3) To run a clinical trial with 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.

This current phase of the project focuses on parts of goals 1 and 2, as described below.

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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

Anthony Rosen, MD

PRINCIPAL_INVESTIGATOR

Chelsie Burchett, PhD

CONTACT

[email protected]

646-962-7141

Sara J Czaja, PhD

PRINCIPAL_INVESTIGATOR

About this study

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 mistreatment than other older adults, and the risk of mistreatment has been shown to be greater with increasing severity of dementia. This mistreatment is usually perpetrated by caregivers.

Screening for elder mistreatment and initiation of intervention in primary care clinics may be helpful, but few evidence-based tools or strategies exist. As few tools exist that may be effectively used in a busy clinical setting, evidence of the impact of screening and potential subsequent intervention on patient-important outcomes is lacking. Further, existing tools were developed for and studied in cognitively intact older adults and may not be appropriate for older adults with AD/ADRD.

In addition, elder mistreatment includes physical abuse, sexual abuse, verbal/emotional/psychological abuse, financial exploitation, and caregiver neglect. These different types of elder mistreatment represent very different phenomena, occur in various groups of older adults, and respond to very different intervention strategies. These discrepancies have made connecting positive identifications of mistreatment in the primary care setting to the next steps, including interventions, very challenging. Focusing on an intervention for caregiver neglect in older adults with dementia has the potential to address these challenges. Given that the severity of dementia represents a significant risk factor in the caregiving relationship, our goal is to provide support for dementia caregivers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 21 years old or older
  • Provides care for a patient at the Center on Aging who meets the following criteria:
  • Patient is at least 65 years old
  • Patient has diagnosed dementia
  • Patient requires assistance with at least 1 ADL
  • Self-identifies as primary informal caregiver for an older adult
  • Provides at least 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)
  • Can read and speak English at a 6th grade level or above
  • Not blind or deaf
  • No active plan to disengage from providing care to the older adult within the next year
  • Ability to travel to the COA or CABR for study activities and/or attend study session(s) virtually through Zoom on their personal device

Exclusion criteria

  • Non-fluent English speaker
  • Hired caregiver
  • Provides care for a patient in hospice care
  • Too ill or weak to complete the interviews (per the interviewer)

Treatment and study plan

SIRENS

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.

Primary outcomes

  1. Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by the Mean Difference in Score of the Program Evaluation Questionnaire.

    Time frame: 1 week post-intervention

    System feasibility, acceptability and usability will be assessed in the Program Evaluation Questionnaire. This is based on the Davis Perceived Usefulness, Perceived Ease of Use, and User Acceptance Scale. Response options range from 1= Strongly Disagree to 7= Strongly agree. Questions include those asking about the technology and components of the intervention. Total scores range from 23 to 161. Higher scores indicate greater user acceptance of the technology.

  2. Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by a qualitative interview assessment

    Time frame: 1-week post intervention

    System feasibility, acceptability and usability will be assessed in care partner participants using a semi-structured interview. Thematic analyses will be used to assess qualitative interviews.

Secondary outcomes

  1. Mean difference in score of caregiver burden, as measured by the Zarit Caregiver Burden Assessment.

    Time frame: Baseline and 1 week post-intervention

    Caregiver burden will be assessed in care partner participants using the reliable and valid Zarit Caregiver Burden Assessment. 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.

  2. Mean difference in score of caregiver quality of life, as measured by the Quality of Life Inventory

    Time frame: Baseline and 1 week post-intervention

    Caregiver quality of life will be assessed in care partner participants using the reliable and valid Quality of Life Inventory. 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.

  3. Mean difference in score of caregiver preparedness, as measured by the Caregiver Preparedness Scale

    Time frame: Baseline and 1 week post-intervention

    Caregiver preparedness will be assessed in care partner participants using the 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.

  4. Mean difference in score of caregiving self-efficacy, as measured by the Caregiving Self-Efficacy Scale

    Time frame: Baseline and 1 week post-intervention

    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.

  5. Mean difference in score of caregiver depression, as measured by the Center for Epidemiologic Studies Depression Scale

    Time frame: Baseline and 1 week post-intervention

    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.

Study contacts

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

Chelsie Burchett, PhD

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: Technology-Based Intervention Usability and Pilot Testing

Acronym: SIRENS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2025
Registry last updated
Sep 25, 2025

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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