Technology-Based Intervention Usability and Pilot Testing

N/ANot Yet RecruitingNCT07146581

Weill Medical College of Cornell University40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1-week post intervention

Secondary Outcomes

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

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.