Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03577418
Status:
WITHDRAWN
Last Update Posted:
2023-10-19
First Post:
2018-06-23
Brief Title:
Enhancing Everyday Autonomy for People With Dementia
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
Enhancing Everyday Autonomy as a Means to Reduce the Neuropsychiatric Symptoms of Dementia
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study never started was not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 morbiditymortality 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 hisher 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 PWDs 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
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 hisher 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 PWDs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None