Enhancing Everyday Autonomy for People With Dementia

• ClinicalTrials.gov Identifier: NCT03577418
• Recruitment Status: Not yet recruiting
• First Posted: July 5, 2018
• Last Update Posted: September 2, 2020
• Sponsor: Mclean Hospital
• Information provided by (Responsible Party): James Wilkins, Mclean Hospital

Study Description

Brief Summary:

Dementia is a highly disabling major neurocognitive disorder. Although cognitive symptoms drive the diagnosis of dementia, neuropsychiatric symptoms (NPS), such as agitation, aggression, and psychosis, are common and associated with increased morbidity/mortality, increased care partner distress, and earlier institutionalization. Although these symptoms are debilitating and experienced by more than 90% of people with dementia, there are currently no FDA-approved treatments. There remains a critical need for safe and effective interventions for NPS that can be easily administered and monitored in typical clinical settings.

One hypothesis for the etiology of NPS is that, as cognitive impairment progresses, there is a decline in the sense of autonomy and an increase in unmet needs that a person with dementia (PWD) is unable to meet on his/her own and that care partners lack the knowledge or ability to meet. As care partners become increasingly involved as surrogate decision-makers for a PWD, the quality of life for a PWD is directly impacted by the decisions made by a surrogate. Several studies have explored agreement between PWDs and surrogate decision-makers regarding various preferences. Results have indicated that discrepancy between a PWD's preferences and those identified by a surrogate decision-maker is common.

According to our conceptual model, such discrepancy may give rise to NPS. Thus, the proposed pilot project directly addresses major gaps in the availability of safe, effective, and accessible strategies to reduce NPS and NPS-related care partner distress by developing and testing a novel educational intervention that directly targets discrepancies regarding everyday preferences. We will randomize 30 dyads comprising people with clinically significant cognitive impairment (mild cognitive impairment or dementia) and their care partners. The dyads will be randomized to either 1) the intervention arm in which there is a clinician-facilitated discussion between the dyad pair about NPS, the unmet needs hypothesis, and areas of discrepancy in everyday preferences and 2) the enhanced usual care arm in which a standardized document describing NPS and the unmet needs hypothesis will be given to the dyad to review. Primary efficacy will be measured by the Neuropsychiatric Inventory brief questionnaire form (NPI-Q), which allows for assessment of both NPS burden as well as burden of caregiver stress. Assessments will be made at baseline, week 4, and week 8.

Condition or disease	Intervention/treatment	Phase
Dementia	Behavioral: Clinician-facilitated educational intervention; Behavioral: Enhanced usual care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Enhancing Everyday Autonomy as a Means to Reduce the Neuropsychiatric Symptoms of Dementia
• Estimated Study Start Date: July 2022
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: May 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Clinician-facilitated educational intervention	Behavioral: Clinician-facilitated educational intervention; People with dementia (PWD) will complete the Preferences for Everyday Living (PELI). Care partners will complete the PELI from the perspective of the PWD (i.e., as if acting as surrogate decision-makers). Research staff will then review these assessments, highlighting areas of discrepancy in the importance of various preferences. A 30-minute preferences-based discussion will then be facilitated by the research clinician. This discussion will include review of the discrepancies identified in the assessments. The PWD and the care partners will then be encouraged to identify one area of discrepancy and to come together with a concrete action plan to resolve that area of discrepancy. A standardized document describing neuropsychiatric symptoms and reviewing the unmet needs hypothesis will be discussed with PWD and the care partners.
Active Comparator: Enhanced usual care	Behavioral: Enhanced usual care; In addition to the usual clinical care, the standardized document describing NPS and reviewing the unmet needs hypothesis will be given to the PWD and the care partner to review.

Outcome Measures

Primary Outcome Measures :

1. NPI-Q [ Time Frame: 4 weeks, 8 weeks ]
   Change in Neuropsychiatric Inventory brief questionnaire form (NPI-Q). The NPI-Q measures the burden of 12 neuropsychiatric symptoms of dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating. Symptom severity is rated on a 3-point scale with higher scores indicating worse symptoms. Minimum score would be 0 and maximum score would be 36.

Secondary Outcome Measures :

1. NPI-Q, caregiver distress [ Time Frame: 4 weeks, 8 weeks ]
   Change in Neuropsychiatric Inventory brief questionnaire form (NPI-Q) caregiver distress. The NPI-Q measures the caregiver distress of 12 neuropsychiatric symptoms of dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating. Symptom severity is rated on a 5-point scale with higher scores indicating worse symptoms. Minimum score would be 0 and maximum score would be 60.

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Individuals who are 55 years or older with a diagnosis of MCI (mild cognitive impairment) or mild to moderate dementia will be eligible (Montreal Cognitive Assessment Score, MoCA, > 10).
• Evidence of neuropsychiatric symptoms of dementia (NPI-Q score > 1).
• People with cognitive impairment must have an identified care partner: a family member, close friend, or caregiver who knows the person well with contact at least three times/week.

Exclusion Criteria:

• None.

Contacts and Locations

Contacts

Contact: James Wilkins, MD, DPhil; 6178553982; jwilkins1@partners.org

Sponsors and Collaborators

Mclean Hospital

Investigators

• Principal Investigator: James Wilkins, MD, DPhil; Mclean Hospital

More Information

• Responsible Party: James Wilkins, Assistant Medical Director, Cognitive Neuropsychiatry Program, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT03577418
• Other Study ID Numbers: R03.JMW
• First Posted: July 5, 2018
• Last Update Posted: September 2, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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