Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia: The Healthy Patterns Study
Brief Summary: The Healthy Patterns Study intervention is a home-based activity intervention designed to improve symptoms of circadian rhythm disorders (CRD) and quality of life (QOL) in home-dwelling persons with dementia. We will use a randomized two-group parallel design of 200 people with dementia and their caregivers assigned to intervention or attention control groups.


Options:
A: Inclusion Criteria:

* Patients residing in long term nursing home units for at least 4 weeks prior to study
* Diagnosed with probable or possible dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), FAST score \> 4
* Diagnosed with depression ≥ 4 week duration as measured by CSDD ≥ 8
* Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant

Exclusion Criteria:

* The patient is contra-indicated to study drugs of pain treatment, in another trial, or had no carer.
* Participants are ineligible if they are clinical critical (e.g. suicide risk)
* Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering
* Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation
* Psychosis or other severe mental disorder prior to dementia diagnosis
* Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom
* Schizophrenia, schizoaffective disorder and bipolar disorder
* Uncontrolled epilepsy
* Severe liver impairment
* Renal failure
* Severe injury or anaemia (Hb \< 8.5 mmol/l), comatose state, current enrolment in another experimental protocol
* Known allergy or adverse reaction to paracetamol or buprenorphine transdermal patch
* Advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder.
* Patients with diseases that make it impossible to follow the research schedule are excluded
B: Inclusion Criteria:

* Sleep complaints
* Community-dwelling (not in a long term care facility)
* Read, write, and speak English
* Able to walk independently
* In sufficient health to participate in regular physical activity

Exclusion Criteria:

* Diagnosis of obstructive sleep apnea
* Receiving continuous positive air pressure (CPAP) treatment
* Diagnosed with dementia of any type
* At high risk for cardiac complications during physical activity or unable to self-regulate activity or understand recommended activity level
* Have a clinically important peripheral neuropathy or sever musculoskeletal or joint disease that impairs mobility
C: Inclusion criteria for care receiver (CR):

1. be over age 60
2. English speaking
3. be able to tolerate wrist actigraphy (wear a watch on their wrist for a month)
4. diagnosed with dementia using standard assessments and diagnostic criteria
5. has CG reporting the presence of CRD symptoms
6. If the CR is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that the CR have been on a stable dose for 90 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications

Inclusion criteria for caregiver (CG):

1. CG is at least 18 years old
2. CG lives close to the participant
3. CG is planning to live in the area for at least 6 months
4. If CG is on a psychotropic medication, CG must be on a stable dose for at least 60 days

Exclusion criteria for CR:

1. deemed to be in a crisis/unsafe situation at baseline
2. reported planned transition to another residential or care setting in less than 6 months
3. at end-stage disease (defined as bed-bound and noncommunicative, or on hospice at baseline)
4. currently enrolled in an interventional clinical trial for dementia or associated symptoms
5. regular use of medications with substantial known effects on the measurement of HPA activity (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy)
6. major surgery in the past 3 months
7. history of major psychiatric and/or personality disorder
8. history of heavy cigarette smoking (e.g. than 50 pack years)
9. loss of a loved one in the past 3 months
10. conditions known to affect measurement of circadian rhythm such as use of sedatives/ hypnotics, Huntington's disease, Cushing's disease, Addison's disease, normal pressure hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3-4), morbid obesity (BMI 35)
D: Inclusion Criteria:

Fifty-five years of age or older; Diagnosis of probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association criteria; Hachinski Ischemia Scale score less than 5 Mini-Mental State Examination score of O to 26 Actigraph evidence of a mean time immobile of less than 7 hours per night based on at least 7 nights of complete actigraph data collected over a single week; For-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI) Nighttime Behavior scale; Sleep disturbance observed was not present before the diagnosis of AD; Other co-morbidities, especially delirium, depression, chronic pain and medication use may be present, but do not cooperate in the primary symptoms; Computed tomography or magnetic resonance imaging since the onset of memory problems showing no more than 1 lacunar infarct in a nonstrategic area and no clinical events suggestive of stroke or other intracranial disease or normal; Stable medications for 4 weeks prior to the screening visit; Having a mobile upper extremity to which to attach an actigraph; Residing with a responsible spouse, family member, or professional caregiver who is present during the night and would agree to assume the role of the principal caregiver for the 3-week protocol; Ability to ingest oral medication and participate in all scheduled evaluations

Exclusion Criteria:

Sleep disturbance associated with an acute illness, delirium or psychiatric disease; Clinically significant movement disorder, such as akinesia, that would affect actigraphic differentiation of sleep and wakefulness Severe agitation; Unstable medical condition; Discontinuation of psychotropic or sleep medications within 2 weeks of the screening visit; Patient unwilling to maintain caffeine abstinence after 2:00 PM for the duration of the protocol; Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00 PM for the duration of the protocol; Prior use of mirtazapine for the treatment of sleep disturbances; Caregiver deemed too unreliable to supervise the wearing of the actigraph, to administer trazodone the proper time, to maintain tbe sleep diary, or to bring the patient to the scheduled visits;

Answer: C