Hodgson 2021.

Study name	A timed activity protocol to address sleep‐wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial.
Methods	Randomised controlled trial 2‐group parallel design of 200 people living with dementia and their carers (dyads)
Participants	Inclusion criteria: aged > 60 years English speaking able to tolerate wrist actigraphy and saliva collection procedures has carer reporting the presence of sleep wake disorder symptoms diagnosed with probable dementia using standard assessments person living with dementia is receiving psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anticonvulsant) or an antidementia medication (memantine or a cholinesterase inhibitor): requires that they will have been on a stable dose for 90 days prior to enrolment to minimise possible confounding effects of concomitant medications and in line with typical time frames in dementia clinical trial Exclusion criteria: deemed to be in an unsafe situation at baseline planned transition to another residential care setting in ≤ 6 months at end‐stage disease (defined as bed‐bound and non‐communicative or in hospice at baseline) currently enrolled in another interventional clinical trial for dementia diagnosed with conditions known to affect measurement of circadian rhythm such as Huntington's disease, Cushing's disease, Addison's disease, normal pressure hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3–4), or morbid obesity (body mass index > 35) current use of medications with substantial known effects on the measurement of hypothalamic‐pituitary‐adrenal activity (e.g. corticosteroids, interferons, beta‐antagonists, cytotoxic chemotherapy) presence of conditions with potential effects on hypothalamic‐pituitary‐adrenal activity measurement, e.g. major surgery in past 3 months, major psychiatric disorder, history of heavy cigarette smoking (e.g. than 50 pack years), loss of a close friend or family member in past 3 months
Interventions	Intervention: 1‐month home‐based activity intervention designed to improve sleep–wake disorders and quality of life. Involves 4 in‐home visits and 1. assessing individuals' functional status and interests; 2. educating carers on environmental cues to promote activity and sleep; and 3. training carers in using timed morning, afternoon, and evening activities based on circadian needs across the day. Control: attention control group
Outcomes	Quality of life; sleep assessed by objective and subjective indicators including actigraphy, subjective sleep quality; and presence of neuropsychiatric symptoms.
Starting date	September 2018
Contact information	hodgsonn@nursing.upenn.edu
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