Technology-Based Intervention Usability and Pilot Testing

Official title

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

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.

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.

Interventions

• Behavioral SIRENS
  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 outcome measures

• 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]
• Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by a qualitative interview assessment [Time frame: 1-week post intervention]

Secondary outcome measures (5)

• Mean difference in score of caregiver burden, as measured by the Zarit Caregiver Burden Assessment. [Time frame: Baseline and 1 week post-intervention]
• 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]
• Mean difference in score of caregiver preparedness, as measured by the Caregiver Preparedness Scale [Time frame: Baseline and 1 week post-intervention]
• Mean difference in score of caregiving self-efficacy, as measured by the Caregiving Self-Efficacy Scale [Time frame: Baseline and 1 week post-intervention]
• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Weill Cornell Medicine — New York

Identifiers

NCT: NCT07146581 · 24-05027492 · R61AG079012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗