Please select the eligibility criteria that correspond to the clinical trial below.
Title: Reducing Agitation in People With Dementia: the Customized Activity Trial
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 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 and better quality of life compared to PwD in the control intervention); 2) Immediate effects of tailored activities at 3 and 6 months on CG wellbeing, and time spent providing care (Hypothesis: CGs receiving training in tailoring activities will report enhanced wellbeing and less time caregiving compared to the control intervention (3 and 6 months); and 3) Cost effectiveness of the Tailored Activity Program expressed as an incremental cost outcome achieved in the form of CG burden reductions and willingness to pay for burden reductions (3 and 6 months; Hypothesis: Tailoring activities will be cost effective compared to the control intervention at each test occasion). Exploratory aims will evaluate treatment effects on psychotropic medication use and other troublesome behaviors, if effects differ by cognitive status, if CGs receiving the tailored activity program will use activities at 6 months and with what frequency, how time gained is spent, and if frequency/duration of treatment and activity use affects outcomes. If proven efficacious and cost effective, the Tailored Activity Program has potential to transform clinical practice by offering a proven nonpharmacologic treatment for agitation of PwDs at home. This trial addresses a critical clinical need and public health priority identified by recent legislative activity.


Options:
A: Patient Inclusion Criteria:

* Currently a patient within Wishard Health Services in Central Indiana
* Diagnosed with possible or probable Alzheimer's Disease
* Age 45 or older
* English speaking
* Hear well enough to answer questions in person or by telephone
* Community-dwelling (includes senior communities, but not skilled nursing facilities)
* Caregiver willing to participate in the study
* Willing to receive home visits
* Lives in Indianapolis metro area and planning to continue care at primary care clinic

Caregiver Inclusion Criteria

* Age 18 or older
* English speaking
* Hear well enough to answer questions in person or by telephone
* Community-dwelling
* Willing to receive home visits

Exclusion Criteria:

* Not a current patient within Wishard Health Services
* Does not speak English
* Currently enrolled in another study
* Non-community dwelling, or residing in a skilled nursing facility
B: Inclusion Criteria: 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 Criteria: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.
C: Inclusion Criteria:

1. Lives in the community and speaks English
2. adult aged 50-90 years old
3. lives with someone who can provide consent to be in the study
4. diagnosed with some form of dementia
5. cognitive score on the Mini-Mental Status Examination score \>10 but ≤25
6. able to understand and follow one step commands
7. can move one arm sufficiently for practicing tasks
8. participant or family member can identify three goal areas related to self-care or home management
9. able to participate in 3 hours of daily therapy in their home environment for 2 consecutive weeks

Exclusion Criteria:

1. Creutzfeldt-Jakob Dementia, delirium or a progressive neurological condition such as Parkinson's disease
2. receptive or global aphasia
3. uncorrected vision/hearing
D: Inclusion Criteria:

* Male or female age 60-90 years
* Patients diagnosed with Alzheimer's Disease, according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and NINCDS-ADRDA (National Institute for Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association) criteria
* Score between 18 and 26 on the Mini Mental State Examination
* Have a CDR (Clinical Dementia Rating) of 1.0
* If medicated for AD, then use of cholinesterase inhibitors, for at least 3 months and on stable dose for at least 60 days prior to screening.

Exclusion Criteria:

* Pre-existing structural brain abnormalities,
* Other neurologic or psychiatric diagnoses
* Transcranial direct current stimulation criteria: patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy; any other condition that might limit or interfere in the sensorimotor system

Answer: B