Technology-Based Intervention Usability and Pilot Testing

NCT07146581 | Not Yet Recruiting

• 2 other identifiers: 24-05027492R61AG079012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia; Elder Abuse; Elder Neglect

Keywords

Older Adults; Technology

Outcome Measures

Primary Outcomes (2)

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

  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.

  1 week post-intervention

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

  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.

  1-week post intervention

Secondary Outcomes (5)

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

  Baseline and 1 week post-intervention

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

  Baseline and 1 week post-intervention

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

  Baseline and 1 week post-intervention

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

  Baseline and 1 week post-intervention

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

  Baseline and 1 week post-intervention

Study Arms (1)

Experimental: SIRENS Intervention

EXPERIMENTAL

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.

Behavioral: SIRENS

Interventions

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.

Experimental: SIRENS Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

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

• Anthony Rosen, MD

  Weill Cornell Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Sara J Czaja, PhD

  Weill Cornell Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsie Burchett, PhD

CONTACT

6469627141; cob2014@med.cornell.edu

Study Design

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

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: October 18, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

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)