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The Healthy Patterns Study

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ClinicalTrials.gov Identifier: NCT03682185
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Attention-Control Condition Behavioral: Timed Activity Intervention Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia: The Healthy Patterns Study
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021


Arm Intervention/treatment
Experimental: Timed Activity Intervention Protocol
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.
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.

Active Comparator: 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: 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.




Primary Outcome Measures :
  1. CRS Symptoms from actigraphy [ Time Frame: 4 Months ]

    Measured using a Motionlogger actigraphy bracelet worn by CR for consecutive 24-hour periods for one whole month. The actigraph will measure:

    i Number of minutes of wake after sleep onset (WASO) ii.Total sleep time (TST) iii.Day/night sleep ratio iv.Number of night awakenings


  2. QOL-AD [ Time Frame: 4 Months ]
    Person with dementia quality of life.


Secondary Outcome Measures :
  1. Neuropsychiatric Inventory (NPI) [ Time Frame: 4 Months ]
    Neuropsychiatric Behaviors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682185


Contacts
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Contact: Laurel Caffeé 267-702-6447 HealthyPatternsSleepStudy@gmail.com

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Laurel Caffeé    267-702-6447    HealthyPatternsSleepStudy@gmail.com   
Contact: Sonia Talwar    267-702-6447    HealthyPatternsSleepStudy@gmail.com   
Sponsors and Collaborators
University of Pennsylvania

Publications:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03682185     History of Changes
Other Study ID Numbers: 825000
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Pennsylvania:
Neuropsychiatric Behaviors
Agitation
Alzheimer's Disease
Dementia

Additional relevant MeSH terms:
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Disease
Alzheimer Disease
Dementia
Cognitive Dysfunction
Sleep Wake Disorders
Parasomnias
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Dementia, Vascular
Neurocognitive Disorders
Disorders of Excessive Somnolence
Chronobiology Disorders
Sleep Disorders, Circadian Rhythm
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Cognition Disorders
Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders