The Healthy Patterns Sleep Study

University of Pennsylvania

Status and phase: Completed; Phase 3

Conditions: Cognitive Impairment; Circadian Rhythm Sleep Disorder; Cognitive Decline; Insomnia; Memory Impairment; Neurocognitive Disorders; Hypersomnia; Alzheimer Disease; Frontotemporal Dementia; Mild Cognitive Impairment; Sleep Disorder; Vascular Dementia; Circadian Rhythm Disorders; Dementia

Treatments: Behavioral: Timed Activity Intervention; Behavioral: Attention-Control Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT03682185

1R01NR015226-01A1 (U.S. NIH Grant/Contract)

825000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 421 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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421 participants in 2 patient groups

Timed Activity Intervention Protocol

Experimental group

Description:

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.

Treatment:

Behavioral: Timed Activity Intervention

Attention-Control Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Attention-Control Condition