About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Aged ≥ 60 years
Community-dwelling
Patient of WCM/NYP
Has diagnosis of dementia (based on medical records prior to enrollment)
Trial design
Parallel
Treatments tested in this trial
SIRENS application
BehavioralThe 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.
SIRENS screening
Other interventionThe SIRENS screening tool is a novel, easy-to-use, brief screening tool to identify elder neglect in primary care settings.
Treatment groups
Trial outcomes
Primary outcomes
Percent change in number of participants with the presence of neglect determined by the Vulnerable Elder Protection Team (VEPT) from baseline at 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.
Secondary outcomes
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
The VEPT Expert Panel's impression of the change in severity of neglect will be measured by the Health-Related Severity in Elder Neglect Scale. This scale asks providers two yes/no questions whether there is concern for caregiver neglect based on the screening tools and clinical assessment. If yes, their level of concern is asked based on the scale: Not Present; Not Present, Potential Risk; Present, Mild; Present, Moderate; and Present, Severe. There is no numerical or total score.
Mean change in score for caregiver burden from baseline at 6 months.
Caregiver burden will be assessed in care partner participants using the reliable and valid Caregiver Burden Scale. 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.
Mean change in score of caregiver quality of life from baseline at 6 months
Caregiver quality of life will be assessed in care partner participants using the reliable and valid Quality of Life Inventory survey. Questions include those asking about importance (on a 3-point rating scale, higher value indicating more importance) and satisfaction (on a 6-point rating scale, higher value indicating more satisfaction) of life domains. Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine the overall score. Overall scores range from -96 to 96, with higher scores indicating higher quality of life.
Mean change in score of older adult quality of life from baseline at 6 months
Older adult quality of life will be assessed in patients using the reliable and valid Quality of Life Dementia survey. Questions include those asking about subjective wellbeing using a 5-point rating scale across five domains: self-esteem, positive affect, negative affect, feelings of belonging, sense of aesthetics. Mean scores are computed for each domain, with high scores indicating more satisfaction (negative affect is reverse scored). Domain scores range from 1 to 5, with higher scores indicating higher quality of life. There is no total overall score.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: