The Healthy Patterns Sleep Study

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.

Conditions

• 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

Interventions

BEHAVIORAL

Attention-Control Condition

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.

BEHAVIORAL

Timed Activity Intervention

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.

Sponsors & Collaborators

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Nancy A. Hodgson · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-01

Primary Completion

2021-05-31

Completion

2021-05-31

Countries

• United States

Study Locations