Back to resultsThe Healthy Patterns Sleep Study
Primary Purpose
Dementia, Alzheimer Disease, Circadian Rhythm Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Attention-Control Condition
Timed Activity Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Neuropsychiatric Behaviors, Agitation, Alzheimer's Disease, Dementia
Eligibility Criteria
Inclusion criteria for care receiver (CR):
- be over age 60
- English speaking
- be able to tolerate wrist actigraphy (wear a watch on their wrist for a month)
- diagnosed with dementia using standard assessments and diagnostic criteria
- has CG reporting the presence of CRD symptoms
- 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):
- CG is at least 18 years old
- CG lives close to the participant
- CG is planning to live in the area for at least 6 months
- If CG is on a psychotropic medication, CG must be on a stable dose for at least 60 days
Exclusion criteria for CR:
- deemed to be in a crisis/unsafe situation at baseline
- reported planned transition to another residential or care setting in less than 6 months
- at end-stage disease (defined as bed-bound and noncommunicative, or on hospice at baseline)
- currently enrolled in an interventional clinical trial for dementia or associated symptoms
- regular use of medications with substantial known effects on the measurement of HPA activity (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy)
- major surgery in the past 3 months
- history of major psychiatric and/or personality disorder
- history of heavy cigarette smoking (e.g. than 50 pack years)
- loss of a loved one in the past 3 months
- 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)
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Timed Activity Intervention Protocol
Attention-Control Condition
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03682185
Brief Title
The Healthy Patterns Sleep Study
Official Title
The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia: The Healthy Patterns Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Neuropsychiatric Behaviors, Agitation, Alzheimer's Disease, Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Timed Activity Intervention Protocol
Arm Type
Experimental
Arm 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.
Arm Title
Attention-Control Condition
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Attention-Control Condition
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Timed Activity Intervention
Intervention 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.
Primary Outcome Measure Information:
Title
The Quality of Life in Alzheimer's Disease Scale (QOL-AD)
Description
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.
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory (NPI)
Description
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).
Time Frame
4 Months
Other Pre-specified Outcome Measures:
Title
Circadian Rhythm Symptoms from actigraphy
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for care receiver (CR):
be over age 60
English speaking
be able to tolerate wrist actigraphy (wear a watch on their wrist for a month)
diagnosed with dementia using standard assessments and diagnostic criteria
has CG reporting the presence of CRD symptoms
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):
CG is at least 18 years old
CG lives close to the participant
CG is planning to live in the area for at least 6 months
If CG is on a psychotropic medication, CG must be on a stable dose for at least 60 days
Exclusion criteria for CR:
deemed to be in a crisis/unsafe situation at baseline
reported planned transition to another residential or care setting in less than 6 months
at end-stage disease (defined as bed-bound and noncommunicative, or on hospice at baseline)
currently enrolled in an interventional clinical trial for dementia or associated symptoms
regular use of medications with substantial known effects on the measurement of HPA activity (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy)
major surgery in the past 3 months
history of major psychiatric and/or personality disorder
history of heavy cigarette smoking (e.g. than 50 pack years)
loss of a loved one in the past 3 months
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A. Hodgson
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24378361
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.
Results Reference
background
PubMed Identifier
20921879
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.
Results Reference
background
PubMed Identifier
18370580
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.
Results Reference
background
PubMed Identifier
29361067
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.
Results Reference
background
PubMed Identifier
29161539
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.
Results Reference
background
PubMed Identifier
27986794
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.
Results Reference
background
PubMed Identifier
27339865
Citation
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.
Results Reference
background
PubMed Identifier
34344312
Citation
Hodgson NA, Gooneratne N, Perez A, Talwar S, Huang L. A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial. BMC Geriatr. 2021 Aug 3;21(1):451. doi: 10.1186/s12877-021-02397-2.
Results Reference
derived
PubMed Identifier
33853394
Citation
Hwang Y, Connell LM, Rajpara AR, Hodgson NA. Impact of COVID-19 on Dementia Caregivers and Factors Associated With their Anxiety Symptoms. Am J Alzheimers Dis Other Demen. 2021 Jan-Dec;36:15333175211008768. doi: 10.1177/15333175211008768.
Results Reference
derived
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The Healthy Patterns Sleep Study
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