跳至主要内容
临床试验/NCT07146581
NCT07146581尚未招募不适用

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

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
2
主要终点
Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by the Mean Difference in Score of the Program Evaluation Questionnaire.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Caregiver Inclusion Criteria
  • 21 years old or older
  • Provides care for a patient of Weill Cornell Medicine/NewYork-Presbyterian who meets the following criteria: (pilot only)
  • 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 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

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: SIRENS (Behavioral)

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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