Status:
COMPLETED
Reducing Agitation in People With Dementia: the Customized Activity Trial
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Dementia
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). A hallma...
Detailed Description
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). A hallma...
Eligibility Criteria
Inclusion
- Inclusion criteria pertain to both the person with dementia (PwD) and the caregiver (CG) such that if either is eligible but the other is not, the dyad is not enrolled.
- PwD and caregiver are English speaking
- Diagnosed with probable dementia
- PwD is able to participate in at least 2 activities of daily living (bathing, dressing, grooming, toileting, transferring from bed to chair)
- Person with dementia exhibits agitated or aggressive behaviors
- If PwD is on a psychotropic medication he/she must be on a stable dose for at least 60 days
- CG is at least 21 years old
- CG lives with or within 5 miles of the person with dementia
- CG is accessible by telephone to schedule interviews and sessions
- CG is planning to live in the area for at least 6 months
- If the CG is on a psychotropic medication he/she must be on a stable dose for at least 60 days
Exclusion
- Exclusion criteria pertain to both the person with dementia and the caregiver such that if either is eligible but the other is not, the dyad is not enrolled.
- PwD has a history of schizophrenia or bipolar disorder
- Dementia is secondary to probable head trauma
- PwD is not responsive to environment (e.g., unable to understand short commands or recognize a person coming in/out of the room).
- the CG is currently involved in another clinical trial of psychosocial or educational interventions
- the CG is planning to place PwD in a nursing home within 6 months.
- dyads will be excluded if either CG or PwD: 1) has a terminal illness with life expectancy \< 6 months, 2) is in active treatment for cancer, or 3) has had \> 3 acute medical hospitalizations in past year.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2017
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01892579
Start Date
November 1 2013
End Date
November 23 2017
Last Update
September 23 2019
Active Locations (1)
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1
Johns Hopkins University School of Nursing, Center for Innovative Care in Aging
Baltimore, Maryland, United States, 21205