An Intervention to Reduce Discrepancy in Everyday Preferences

NCT03577418 | Not Yet Recruiting

• 1 other identifier: R21.JMW
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dementia; everyday preferences; neuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

• Discrepancy score

  To calculate a discrepancy score for each dyad (i.e., PLWD/CI and care partner), a mean domain score for both assessments PEL-CI and PELI-CP will be calculated as the average of all non-missing data for each assessment. The discrepancy score will then be obtained by subtracting the mean domain score for assessment PELI-CP from the mean domain score for assessment PELI-CI for each dyad.

  8 weeks

Secondary Outcomes (1)

• NPI-Q

  8 weeks

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Community-dwelling persons 55 years or older with a primary diagnosis of MCI or mild to moderate dementia will be eligible (Montreal Cognitive Assessment Score, MoCA, \> 10).24,25 PLWD/CI must have an identified care partner: a family member or close friend who knows the person well with contact at least three times/week. Informed consent will be obtained; if PLWD/CI are not able to provide informed consent, healthcare proxies will be asked to provide informed consent, with assent provided by PLWD/CI. The study clinician (board-certified geriatric psychiatrist) will be available to participants if unstable NPS develop during the study period. Participants must be fluent in written and oral English. PLWD/CI who are not experiencing any NPS at baseline (i.e., NPI-Q score of zero at baseline) will be excluded. PLWD/CI living in long-term care environments (e.g., nursing home, assisted living facility) will be excluded. Persons with comorbid active primary psychiatric illness (e.g., major depressive or bipolar mood disorders, psychotic disorders) will be excluded. We will recruit 20 dyads comprising PLWD/CI and the care partner.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• James Wilkins, MD, DPhil

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Wilkins, MD, DPhil

CONTACT

6178553982; jwilkins1@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Medical Director, Cognitive Neuropsychiatry Program

Study Record Dates

• First Submitted: June 23, 2018
• First Posted: July 5, 2018
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)