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: Inclusion Criteria:

* aged 65 years or older
* mild to moderate dementia (MMSE 10-24)
* living in the community at maximum of 50 kilometers from the Memory Clinic
* having an informal primary caregiver who was involved in the care for the patient at least once a week

Exclusion Criteria:

* depression: score \> 12 on the Geriatric Depression Scale
* severe behavioral or psychological symptoms in dementia (BPSD) judged by a geriatrician
* severe illnesses, judged by a geriatrician
* no OT goals, determined by the researcher or research assistant
* caregivers having severe illnesses
B: Inclusion Criteria:

* Care Recipient
* English Speaking
* NINCDS-ADRDA diagnosis\[physician generated of dementia or mini-mental state examination score of less than or equal to 23;3\] Able to feel self; and participates in at least 2 other activities of daily living\[ADLs-Bathing, Dressing, Grooming, Toileting, Transferring from bed to chair\] As reported by caregiver.
* Caregiver
* English Speaking
* Family member 21 years of age or older \[male or female\]
* Lives with Care Recipient
* Has telephone in the home
* Plans to live in area for 8 months
* Indicated willingness to learn new approaches by which to engage care recipient in meaningful activities
* Provides 4 or more hours a day directly caring or providing for care recipient

Exclusion Criteria:

* Care Recipient
* Has Schizophrenia or Bi-Polar Disorder
* Their Dementia is secondary to probable head trauma
* Their MMSE score is equal to zero and they are bed bound, defined as confinement to bed or chair for at least 22 hours a day for at least 4 of 7 days
* They are not responsive to their environment
* Caregiver
* Are currently involved in another clinical trial of psycho-social or educational interventions for caregivers
* Are planning to place their family member in a nursing home within the next 8 months. Also, the care recipient/caregiver dyad will be excluded if either caregiver or care recipient: 1) has a terminal illness with life expectancy less than 8 months 2)is in active treatment for cancer or 3) has had greater than 3 acute medical hospitalizations within the past year.
C: 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.
D: Inclusion Criteria:

* Active client in publicly-funded home care program; Diagnosis of Alzheimer's disease or other dementia OR \>=4 errors on the Mental Status Questionnaire; speaks or understands English

Exclusion Criteria:

* Diagnosed schizophrenia or bipolar disorder; bedbound; participation in experimental drug study to treat agitation; home environment deemed unsafe or unsanitary.

Answer: C