- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577418
Enhancing Everyday Autonomy for People With Dementia
Enhancing Everyday Autonomy as a Means to Reduce the Neuropsychiatric Symptoms of Dementia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks, 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Wilkins, MD, DPhil, McLean Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03.JMW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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