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Not Yet RecruitingNCT07146581

Technology-Based Intervention Usability and Pilot Testing

Primary Care Screening and Intervention for Caregiving Assessment and Support for Patients With Dementia: Technology-Based Intervention Usability and Pilot Testing

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Weill Medical College of Cornell University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSIRENSThe 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.

Timeline

Start date
2025-10-18
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2025-08-28
Last updated
2025-09-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07146581. Inclusion in this directory is not an endorsement.