Primary Care Screening and Intervention for Patients With Dementia and Caregivers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorWeill Medical College of Cornell University

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 volunteers

Qualifiers

None

Disqualifiers

Aged ≥ 60 years

Community-dwelling

Patient of WCM/NYP

Has diagnosis of dementia (based on medical records prior to enrollment)

Trial design

Design model

Parallel

Treatments tested in this trial

  • SIRENS application

    Behavioral

    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.

  • SIRENS screening

    Other intervention

    The SIRENS screening tool is a novel, easy-to-use, brief screening tool to identify elder neglect in primary care settings.

Treatment groups

774 Participants
are divided into 3 treatment groups
Group A: Screening and InterventionExperimental treatment 2 interventions
Group B: Screening onlyActive comparator 1 intervention
Group C: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline; 6 months

Secondary outcomes

1

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.

Time frame
Baseline; 6 months
2

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.

Time frame
Baseline; 6 month
3

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.

Time frame
Baseline; 6 month
4

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.

Time frame
Baseline; 6 month

Other outcomes

Sponsors and contacts

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Weill Medical College of Cornell University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

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