Alzheimer's Disease Education and Referral Center

Reducing Agitation in People with Dementia

Reducing Agitation in People with Dementia

Overall Status: 
Active, not recruiting
Brief Description: 

One of the most significant challenges of dementia care is neuropsychiatric symptoms, including agitation, a common behavior that is associated with increased health care costs, reduced quality of life, heightened caregiver burden, disease acceleration, and nursing home placement. In this clinical trial, a nonpharmacologic, person-centered intervention, the Tailored Activity Program (TAP), will be tested. If proven cost-effective, TAP has potential to transform clinical practice by offering a proven nonpharmacologic treatment for agitation of people with dementia at home.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
21 Years
Inclusion Criteria: 

    Inclusion criteria pertain to both the person with dementia and the caregiver. If either is eligible but the other is not, they will not be enrolled.

    People with Dementia

    • English speaking
    • Diagnosed with probable dementia
    • Able to participate in at least two activities of daily living (including bathing, dressing, grooming, toileting, transferring from bed to chair)
    • Exhibits agitated or aggressive behaviors
    • If on a psychotropic medication, must be on a stable dose for at least 60 days


    • English speaking
    • At least 21 years old
    • Lives with or within 5 miles of the person with dementia
    • Accessible by telephone to schedule interviews and sessions
    • Planning to live in the area for at least 6 months
    • If on a psychotropic medication, must be on a stable dose for at least 60 days
Exclusion Criteria: 

    People with Dementia

    • History of schizophrenia or bipolar disorder
    • Dementia secondary to probable head trauma
    • Unresponsive to environment (for example, unable to understand short commands or recognize a person coming in/out of the room).


    • Currently involved in another clinical trial of psychosocial or educational interventions
    • Planning to place the person with dementia in a nursing home within 6 months

    Both Groups

    • Terminal illness with life expectancy of fewer than 6 months
    • Receiving active treatment for cancer
    • Has had more than three acute medical hospitalizations in the past year
Detailed Description: 

In this Phase III trial, investigators will test a nonpharmacologic intervention, TAP, to reduce agitation in people with Alzheimer's dementia. Participants and their caregivers will be randomly assigned to TAP or a home safety and education program that does not include TAP components. TAP is designed to tap into a person with dementia's abilities and provide an environment that supports these abilities. Activities are selected that build on preserved capabilities, long-term interests, and procedural memory, but that do not tax areas of cognition that are most impaired, such as memory and new learning. High-functioning individuals are introduced to more goal-directed, multi-step activities, whereas lower-functioning individuals are introduced to activities involving repetitive motion (for example, washing windows, folding towels) and multisensory stimulation (for example, soft music). 

TAP has three phases that occur during eight in-home sessions. Phase I (sessions 1-2) involves assessing the person with dementia's capacity and interests, caregiver interactions, the physical environment, and caregiver education. Phase II (sessions 3-6) involves identifying and implementing three "activity prescriptions" tailored to the person. The prescription summarizes the person's capabilities in plain language, identifies the activity and its goal, and provides specific instructions for introducing the activity. Caregivers are trained to integrate activities in daily care. Also taught is deep breathing  to reduce caregiver stress. Phase III (sessions 7-8) involves instructing caregivers to simplify activities for the future.

The control (non-TAP) group will receive an eight-session home safety and education program that includes six in-home visits and two telephone sessions. Sessions include information on home safety, fall risk assessment, talking to your doctor, advanced planning, identifying resources, and caring for the caregiver. It is delivered by a trained research team member who uses active listening, open questioning, reflecting back, and summation with caregivers.

Investigators predict that TAP will reduce agitation and improve quality of life in people with dementia, compared with controls, as rated by caregivers after 3 months and 6 months. TAP is also expected to improve caregivers' well-being and time spent caregiving. Researchers will also explore TAP's impact on use of psychotropic medication and cost of care.

Map Marker CityStateZip CodePrimary Contact

Geolocation is 39.3042055, -76.557493

Johns Hopkins University School of Nursing, Center for Innovative Care in Aging
Katherine A Marx, PhD, MPH
Lead Sponsor: 
Johns Hopkins University
Collaborator Sponsor: 
National Institute on Aging
Facility Investigators: 
Laura N. Gitlin, PhD
Principal Investigator
Johns Hopkins University
Study Contact: 
Katherine Marx
Locations ID 
NCT01892579 (follow link to view full record on in new window)
Official Title: 
Reducing Agitation in People With Dementia: the Customized Activity Trial
Study Start Date: 
November 2013
Study End Date: 
August 2017