Primary Care Screening and Intervention for Caregiving Assessment and Support for Patients With Dementia: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 774
- 试验地点
- 1
- 主要终点
- Percent change in number of participants with the presence of neglect determined by the Vulnerable Elder Protection Team (VEPT) from baseline at 6 months
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact of screening for elder neglect in older adults with dementia in primary care settings and the impact of an intervention for caregivers of older adults with dementia.
The hypothesis of the study are:
- Neglect screening in primary care will have a positive impact on outcomes including a decrease in presence of neglect at 6 months and other patient and caregiver outcomes
- Neglect screening paired with a caregiving intervention will have a greater impact on these outcomes than screening alone
Researchers will compare 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.
Participants will be asked to:
- attend primary care clinic visits
- complete questionnaires
- participate in the intervention
- participate in a semi-structured interview
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Primary care provider Inclusion Criteria • Active PCP who may be a physician or nurse practitioner seeing adult primary care patients with dementia at: Weill Cornell Medicine
- •Primary care provider
排除标准
- •Not a PCP of older adults with dementia who may be at risk of being neglected.
- •Older Adult Inclusion Criteria:
- •Aged ≥ 60 years
- •Community-dwelling
- •Patient of WCM/NYP
- •Has diagnosis of dementia (based on medical records prior to enrollment)
- •Requires assistance with at least 1 ADL
- •Able to travel to a WCM/NYP clinic for study activities
- •Has informal (either unpaid or CDPAP) caregiver who provides ≥8 hours weekly
- •Not already known to be experiencing neglect from caregiver
- •Older Adult Exclusion Criteria:
- •In hospice
- •Decision has already been made to re-locate to an institution (including long-term care skilled nursing facilities)
- •Caregiver Inclusion Criteria:
- •Age ≥ 21 years
- •Living with or near the older adult
- •Self-identifies as a caregiver for the older adult
- •Provides ≥ 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)
- •Able to travel to a WCM/NYP clinic for study activities or participate in study activities virtually through Zoom on their personal device
- •Not a professional caregiver, does not receive direct payment in return for care (unless through CDPAP)
- •Can read and speak English at a 6th grade level
- •No active plan to disengage from providing care to older adult within the next year
- •Caregiver Exclusion Criteria:
- •Unable to read and speak English at a 6th grade level
- •Hired/paid professional caregiver
- •Is blind or deaf
- •Active plan to disengage from providing care to older adult within the next year
研究组 & 干预措施
Screening and Intervention
干预措施: SIRENS application (Behavioral)
Screening and Intervention
干预措施: SIRENS screening (Other)
Screening only
干预措施: SIRENS screening (Other)
Usual care
结局指标
主要结局
Percent change in number of participants with the presence of neglect determined by the Vulnerable Elder Protection Team (VEPT) from baseline at 6 months
时间窗: Baseline; 6 months
Caregiver abuse screen is a yes/no 8-question survey that asks about high stress and tendencies that could lead to future abuse. More "yes" answers indicate higher likelihood of current abuse and neglect, and future risk. The PCP Neglect Screening Questionnaire asks primary care providers for concern for caregiver neglect and level of concern using a 5-point scale. Higher scores indicate increased concern. Provider Observations survey asks for the primary care provider's subjective observations on the older adult's physical health. Electronic Health Record Data Elements survey extracts information from medical charts for hemoglobin, creatinine, and blood urea nitrogen lab results. Information from these surveys are used by the VEPT Expert Panel to determine presence of neglect.
次要结局
- Change in severity of neglect determined by the Vulnerable Elder Protection Team (VEPT) using the Health-Related Severity in Elder Neglect Scale from baseline at 6 months(Baseline; 6 months)
- Mean change in score for caregiver burden from baseline at 6 months.(Baseline; 6 month)
- Mean change in score of caregiver quality of life from baseline at 6 months(Baseline; 6 month)
- Mean change in score of older adult quality of life from baseline at 6 months(Baseline; 6 month)
- Mean change in score of caregiver preparedness from baseline at 6 months(Baseline; 6 month)
- Mean change in score of caregiving self-efficacy from baseline at 6 months(Baseline; 6 month)
- Mean change in score of caregiver depression from baseline at 6 months(Baseline; 6 month)
- Number of heath outcomes determined by medical chart review(6 month)
- Count of the primary care provider's impression of the presence of neglect and severity of neglect measured by the Health-Related Severity in Elder Neglect Scale(Baseline; 6 month)
- Number of individual actions taken after positive neglect screen determined by medical chart review(Baseline; 6 month)
- Change in technology acceptance score from post-intervention at 6 months(Post-intervention (5 week); 6 month)