Weill Cornell Medicine
New York, 10065, United States
NCT Number: NCT07758738
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
Trial opening soon.
Get Notified21 year and older
All sexes
Interventional
Not applicable
New York, 10065, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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 Exclusion Criteria
Older Adult Inclusion Criteria:
Older Adult Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
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.
The SIRENS screening tool is a novel, easy-to-use, brief screening tool to identify elder neglect in primary care settings.
Time frame: 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.
Time frame: Baseline; 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.
Time frame: Baseline; 6 month
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.
Time frame: Baseline; 6 month
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.
Time frame: Baseline; 6 month
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.
Time frame: Baseline; 6 month
Caregiver preparedness will be assessed in care partner participants using the Caregiver Preparedness Scale. Response options range from 0= Not at all prepared to 4= Very well prepared. Overall scores range from 0 to 24 with higher scores indicating more feelings of preparedness.
Time frame: Baseline; 6 month
Caregiving self-efficacy will be measured in care partner participants by a modified Caregiving Self-Efficacy Scale. Response options range from 0= Can not do at all to 100= Certainly can do. Overall scores range from 0 to 900 with higher scores indicating more confidence.
Time frame: Baseline; 6 month
Caregiver depression will be assessed in care partner participants using the reliable and valid Center for Epidemiologic Studies Depression Scale. Response options range from 0= Rarely or none of the time to 3= Most or almost none of the time. Overall scores range from 0 to 60 with higher scores indicating greater depressive symptoms.
Time frame: 6 month
Number of each health outcome such as deaths, hospitalizations and use of medical services. Additional health-related outcomes will be included as identified.
Time frame: Baseline; 6 month
The primary care provider's impression of the presence of neglect and 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.
Time frame: Baseline; 6 month
Number of each individual action taken after positive neglect screen. Actions will be included as identified.
Time frame: Post-intervention (5 week); 6 month
Use of the intervention will be determined by the Technology Acceptance Scale which assesses system acceptance in two dimensions: a Usefulness scale and an affective Satisfying scale. Response options range from -2 to 2. Items 3, 6, and 8 are mirrored and should be scored -2..+2. The Usefulness scale is the sum of item 1 + 3 + 5 + 7 + 9 divided by 5, the Satisfying scale is the sum of items 2, 4, 6, and 8, divided by 4. Each scale has a total score that ranges from -2 to +2, with higher scores indicating more usefulness or satisfaction. The scales are not combined for a total score.
Contact information is provided by the study sponsor or research team.
Weill Medical College of Cornell University
Other
Primary Care Screening and Intervention for Caregiving Assessment and Support for Patients With Dementia: Randomized Controlled Trial
Acronym: SIRENS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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