The Healthy Patterns Sleep Study

Alzheimer Disease Clinical Trial

Official title:

The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia: The Healthy Patterns Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682185
• Other study ID #: 825000
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Chronobiology Disorders
• Circadian Rhythm Disorders
• Circadian Rhythm Sleep Disorder
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Dementia, Vascular
• Disease
• Disorders of Excessive Somnolence
• Frontotemporal Dementia
• Hypersomnia
• Insomnia
• Memory Impairment
• Mild Cognitive Impairment
• Neurocognitive Disorders
• Parasomnias
• Pick Disease of the Brain
• Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders
• Vascular Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (7)

Gitlin LN, Piersol CV, Hodgson N, Marx K, Roth DL, Johnston D, Samus Q, Pizzi L, Jutkowitz E, Lyketsos CG. Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial. Contemp Clin Trials. 2016 Jul;49:92-102. doi: 10.1016/j.cct.2016.06.006. Epub 2016 Jun 21. — View Citation

Hirschman KB, Hodgson NA. Evidence-Based Interventions for Transitions in Care for Individuals Living With Dementia. Gerontologist. 2018 Jan 18;58(suppl_1):S129-S140. doi: 10.1093/geront/gnx152. Review. — View Citation

Hodgson NA, Andersen S. The clinical efficacy of reflexology in nursing home residents with dementia. J Altern Complement Med. 2008 Apr;14(3):269-75. doi: 10.1089/acm.2007.0577. — View Citation

Hodgson NA, Gitlin LN, Winter L, Czekanski K. Undiagnosed illness and neuropsychiatric behaviors in community residing older adults with dementia. Alzheimer Dis Assoc Disord. 2011 Apr-Jun;25(2):109-15. doi: 10.1097/WAD.0b013e3181f8520a. — View Citation

Hodgson NA, Granger DA. Collecting saliva and measuring salivary cortisol and alpha-amylase in frail community residing older adults via family caregivers. J Vis Exp. 2013 Dec 18;(82):e50815. doi: 10.3791/50815. — View Citation

Regier NG, Hodgson NA, Gitlin LN. Characteristics of Activities for Persons With Dementia at the Mild, Moderate, and Severe Stages. Gerontologist. 2017 Oct 1;57(5):987-997. doi: 10.1093/geront/gnw133. — View Citation

Samus QM, Black BS, Bovenkamp D, Buckley M, Callahan C, Davis K, Gitlin LN, Hodgson N, Johnston D, Kales HC, Karel M, Kenney JJ, Ling SM, Panchal M, Reuland M, Willink A, Lyketsos CG. Home is where the future is: The BrightFocus Foundation consensus panel on dementia care. Alzheimers Dement. 2018 Jan;14(1):104-114. doi: 10.1016/j.jalz.2017.10.006. Epub 2017 Nov 21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Circadian Rhythm Symptoms from actigraphy	Measured using a Motionlogger actigraphy bracelet worn by CR for consecutive 24-hour periods for one whole month.; Actigraphic measures of physical activity do not rely on participant self-report and may be of particular importance for efforts to examine the health benefits of physical activity across the full spectrum of older individuals especially those with dementia, a group in which loss of motor function is particularly salient.	30 days
Primary	The Quality of Life in Alzheimer's Disease Scale (QOL-AD)	Person with dementia quality of life. The QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks.	Baseline and 4 months
Secondary	Neuropsychiatric Inventory (NPI)	Neuropsychiatric Behaviors The Neuropsychiatric Inventory Questionnaire (NPI) is an informant-based instrument that measures the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as informant distress.; Neuropsychiatric symptoms are rated by the caregiver within a domain in terms of both frequency (1=rarely, less than once per week; 2=sometimes, about once per week; 3=often, several times per week; and 4=very often, once or more per day) and severity (1=mild; 2=moderate; 3=severe), thus yielding a composite symptom domain score (frequency × severity) ranging from 0 (absence of behavioral symptoms) to 144 points (maximum severity of behavioral symptoms).	4 Months