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NCT01892579 · ClinicalTrials.gov registry record · NA
Reducing Agitation in People With Dementia: the Customized Activity Trial
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
NCT01892579: Completed NA study, sponsored by Johns Hopkins University.
NCT01892579 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01892579, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
Study 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 hallmark of the disease and one of the most significant challenges in dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling and frequently occurring. It is associated with increased health care costs, reduced life quality, heightened caregiver burden, disease acceleration and nursing home placement. Treatment typically involves pharmacologic agents; however, these are at best modestly effective, carry serious risks including mortality, and may not reduce family distress. Recently issued position statements from medical organizations suggest nonpharmacologic strategies as first-line treatment. Nevertheless, nonpharmacological strategies for agitation remain understudied. We propose a Phase III efficacy trial to test a novel 8-session patient-centric intervention, the Tailored Activity Program. We will test the program using a randomized two-group parallel design of 250 people with dementia (PwD) and their CGs (dyads) who will be randomly assigned to received a program of tailored activities or a control intervention of equivalent in-home attention and social contact. The trial assesses PwDs' preserved capabilities, deficits, previous roles, habits, interests and home environment from which activities are developed to match PwD profiles. Families are trained to implement activities and modify them for future decline. Our primary study aim evaluates the effect of tailored activities at 3 months on agitation (Hypothesis: PwD in the tailored activity program will have less frequent agitation compared to the control intervention condition. Three secondary aims evaluate: 1) 6-month effects of tailored activities on agitation and quality of life in PwD (Hypothesis: PwD receiving tailored activities will manifest lower severity scores at 6 months an
Primary Outcome
Frequency by severity of agitated and aggressive behaviors measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver. Frequency for severity for both is calculated and then the numbers are added together.
Interventions
- BEHAVIORAL Tailored Activity Program
- OTHER Home Safety and Education Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-11-23 |
| Phase | NA |
What the finished NCT01892579 record still lists
NCT01892579 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Tailored Activity Program is the first listed.
NCT01892579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01892579 about?
NCT01892579 is a clinical study titled "Reducing Agitation in People With Dementia: the Customized Activity Trial". 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 hallmark of the disease and one of the most significant challenges in dementia care is neuropsychiatric sy...
What is the current status of trial NCT01892579?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2013-11. Estimated completion is 2017-11-23.
What interventions are being tested in trial NCT01892579?
The interventions under investigation include: Tailored Activity Program (BEHAVIORAL), Home Safety and Education Program (OTHER).
Who is sponsoring clinical trial NCT01892579?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01892579's enrollment target sits among peer trials
250 410th of 2000 higher than 1,567 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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