An Intervention to Reduce Discrepancy in Everyday Preferences

Summary

Dementia is a disabling, progressive major neurocognitive disorder. Although cognitive symptoms drive the diagnosis of dementia, neuropsychiatric symptoms (NPS), such as depression, agitation/aggression, and psychosis, are common and associated with a number of significant adverse outcomes. There are currently extremely limited FDA (Food and Drug Administration)-approved treatments for NPS of dementia; there remains a critical need for safe and effective interventions for NPS that can be easily administered and monitored in typical clinical settings. As cognitive impairment progresses, persons living with dementia or cognitive impairment (PLWD/CI) increasingly rely on surrogate decision-makers, such that the quality of life for PLWD/CI is directly impacted by the decisions made by a surrogate. Discrepancy between preferences of PLWD/CI and proxy assessments by surrogate decision-makers is common. Our previous work has shown that such discrepancies in everyday preferences are associated with a higher burden of NPS for PLWD/CI. We hypothesize that discrepancy in everyday preferences assessment between PLWD/CI and care partners creates a set of "unmet needs" that increase the likelihood or severity of NPS; our preliminary data support this model of unmet needs as drivers of NPS. Specifically, as the neurodegenerative process disrupts the ability of PLWD/CI not only to provide for their own needs but also to communicate needs and preferences effectively to others, NPS may emerge in response. Thus, our hypothesis fits within a larger conceptual framework for understanding etiology of NPS: i.e., the mismatch between personality habits, physical/mental states, and environmental factors drive NPS as a means to resolve or communicate unmet needs. Building from this conceptual framework and our own preliminary data, the proposed pilot project addresses major gaps in the availability of safe, effective, and accessible strategies to reduce NPS by developing and testing the feasibility, acceptability, fidelity, and mechanistic target engagement of a templated, clinician-facilitated intervention to align everyday living preferences assessment between PLWD/CI and their care partners (n=20 dyads) to reduce NPS. The study is unique in developing a bioethics-driven intervention for NPS that is effective, portable, and easily transferrable to diverse settings. The crux of this intervention is meeting the needs of PLWD/CI by aligning everyday decision-making with priorities that matter most.

Conditions

• Dementia
• Mild Cognitive Impairment

Interventions

BEHAVIORAL

Templated, clinician-facilitated intervention to align everyday living preferences assessment

In step 1, persons living with dementia or cognitive impairment (PLWD/CI) will complete the PELI (hereafter, "assessment PELI-CI" for Cognitive Impairment) to articulate their preferences. In step 2, care partners will consider the preferences of PLWD/CI; care partners will complete concurrent but separate proxy PELI assessments from the perspective of the PLWD/CI (i.e., as if acting as surrogate decision-makers; hereafter "assessment PELI-CP" for Care Partner). In the Intervention (step 3), the study clinician will ask the PLWD/CI to identify up to 3 "social engagement" preferences that matter most to them. Second, in discussion with the PLWD/CI and care partner, the study clinician will review areas where there is a difference in ratings between the PELI-CI and PELI-CP. The study clinician will then ask the PLWD/CI to identify up to 3 items of disagreement that are most important for the care partner to know about. A 1-page Preferences Priorities document will then be created.

Sponsors & Collaborators

• Mclean Hospital

  lead OTHER

Principal Investigators

• James Wilkins, MD, DPhil · Mclean Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2028-03-31

Completion

2028-03-31

Countries

• United States

Study Locations