The Healthy Patterns Sleep Study
Condition: Dementia; Alzheimer Disease; Circadian Rhythm Disorders; Circadian Rhythm Sleep Disorder; Insomnia; Hypersomnia; Cognitive Impairment; Cognitive Decline; Mild Cognitive Impairment; Frontotemporal Dementia; Neurocognitive Disorders; Vascular Dementia; Sleep Disorder; Memory Impairment
MeSH terms: Alzheimer Disease; Dementia; Sleep Wake Disorders; Parasomnias; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular; Disorders of Excessive Somnolence; Chronobiology Disorders; Sleep Disorders, Circadian Rhythm; Cognitive Dysfunction; Neurocognitive Disorders
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and
      fatal neurodegenerative condition, affecting close to 15 million family caregivers (CG).
      Circadian rhythm disorders (CRDs) occur in the majority of persons with dementia and include
      late afternoon/evening agitation (e.g. sundowning) and irregular sleep-wake rhythms such as
      daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. CRDs can cause a
      specific cluster of neuropsychiatric symptoms that occur in over 60 percent of patients with
      dementia and are associated with increased morbidity and mortality and decreased quality of
      life. Regulating the circadian system via different types of activity have been shown to
      alter core clock processes that drive CRD symptoms and suggests that a combination of
      cognitive, physical, and sensory-based activities, delivered at strategic times, may be an
      effective mechanism to reduce neuropsychiatric symptoms, decrease sleep disruptions, and
      enhance quality of life for both the care receiver and the caregiver.

      Specific components of this brief, one-month, eight sessions, home-based intervention
      include: 1) assessing PWD health/functional status and preferences/interests; 2) educating
      caregivers on environmental cues to promote activity and sleep; and 3) training of caregivers
      in using timed morning, afternoon, and evening activities based on circadian needs across the
      day.
    

Intervention name(s): Attention-Control Condition; Timed Activity Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This condition will contain no active elements beyond its nonspecific components, and no theoretical basis to support an effect on CRDs. The attention-control group will also involve 4 in-home visits and 4 brief telephone education sessions. The attention control group will receive printed educational and training materials from the Alzheimer's Association and the NIH on home modification, health promotion, talking to your doctor, and advanced care planning that coincide with session content.; The timed activity group will involve 4 in-home visits and 4 brief telephone education sessions provided over 4 weeks. The timed activity intervention provides activities delivered at specific times in the daily cycle. The in-home sessions are spaced weekly so that the participants can have the opportunity to practice the activity with the interventionist and then on their own. During each session, the interventionist will reinforce activity use, review problem-solving approaches, and provide education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Neuropsychiatric Behaviors; Agitation; Alzheimer's Disease; Dementia