Please select the eligibility criteria that correspond to the clinical trial below.
Title: Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
Brief Summary: The Tailored Activity Program - Veterans Administration is a Phase III efficacy trial designed to reduce behavioral symptoms in Veterans with dementia living with their caregivers in the community. The study uses a randomized two group parallel design with 160 diverse Veterans and caregivers. The experimental group receives a transformative patient-centric intervention designed to reduce the burden of behavioral symptoms in Veterans with dementia. An occupational therapist conducts an assessment to identify a Veteran's preserved capabilities, deficit areas, previous roles, habits, and interests to develop activities tailored to the Veteran. Family caregivers are then trained to incorporate activities into daily care. The attention-control group receives bi-monthly telephone contact where education on topics relevant to dementia is provided to caregivers. Key outcomes include reduced frequency and severity of behavioral symptoms using the 12-item Neuropsychiatric Inventory (primary endpoint), reduced caregiver burden, enhanced skill acquisition, efficacy using activities, and time spent providing care at 4 months; and long-term effects (8 months) on the Veteran's quality of life and frequency and severity of behavioral symptoms, and caregiver use of activities. The programs' impact of Veterans Administration cost is also examined. Study precision will be increased through face-to-face research team trainings with procedural manuals and review of audio-taped interviews and intervention sessions.


Options:
A: Inclusion Criteria:

Inclusion Criteria for Veterans with dementia include:

* English speaking
* diagnosed with dementia as above
* able to participate in at least two activities of daily living

  * ADLs - bathing
  * dressing
  * grooming
  * toileting
  * transferring from bed to chair
* not currently participating in any other dementia-related intervention.
* If the Veteran with dementia is on any of four classes of psychotropic medications:

  * antidepressant
  * benzodiazepines
  * antipsychotic
  * anti-convulsant
  * an anti-dementia medication (memantine or a cholinesterase inhibitor)
* We will require that he/she have been on a stable dose for 60 days prior to enrollment to minimize possible confounding effects of concomitant medications (the typical time frame used in clinical trials).
* Caregivers of Veterans must be:

  * English speaking
  * self-identify as the primary member of the family caring (hands-on or supervision) for the Veteran and 21 years of age or older (male or female)
  * living with the Veteran
  * accessible by telephone to schedule interview, intervention sessions and follow-up interviews
  * planning to live in area for 8 months (to reduce loss to follow-up)
  * indicate willingness to learn activity use
  * report one or more NPS in the Veteran in the past month
  * not currently participating in any other caregiver-related intervention.
* Finally, we will require that caregivers taking a psychotropic medication (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) at time of telephone screen be on a stable dose of the medication for 60 days prior to enrollment.

Exclusion Criteria:

* Non English speaking
* Non-Veteran
* No caregiver
* No diagnosis of dementia
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:

* Age of 65 years or more and living at home
* Patients in the day care centre group must have attended the centre for at least four weeks and have been there no longer than nine months
* Dementia of either Alzheimer's type, vascular dementia, dementia with Lewy bodies/Parkinson's disease or a mixture of these types of dementias
* Capacity to give informed consent as judged by the professional caregivers
* A Mini Mental Status Examination (MMSE) score of ≥15
* Having a family carer willing to participate, who see the patients personally at least once a week
* Attending the day care centre program at least twice a week

Exclusion Criteria:

* Having applied for nursing home placement
* Suffering from a serious co-morbid physical disorder with life expectancy less than six months
D: 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.

Answer: A