Alzheimer Disease, Circadian Rhythm Disorders, Circadian Rhythm Sleep Disorder, Cognitive Decline, Cognitive Impairment, Dementia, Frontotemporal Dementia, Hypersomnia, Insomnia, Memory Impairment, Mild Cognitive Impairment, Neurocognitive Disorders, Sleep Disorder, Vascular Dementia
Conditions
Keywords
Neuropsychiatric Behaviors, Agitation, Alzheimer's Disease, Dementia
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.
Interventions
BEHAVIORALAttention-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.
BEHAVIORALTimed 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
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale | Baseline and 1 month | Person living 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. Total scores are calculated by summing all domain scores. The total score range is 13 to 52, with higher scores indicating higher quality of life. Total scores were analyzed to see if there was a change from baseline to one month. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. Change scores are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Inventory (NPI) | 4 Months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Circadian Rhythm Symptoms From Actigraphy | 30 days | 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. |
Countries
United States
Participant flow
Pre-assignment details
Persons living with dementia (PLWDs) and their caregivers (also referred to as dyads) are randomly assigned to either the timed activity intervention or the attention control group. All dyads are screened for eligibility prior to enrollment and randomization. The study enrolled one dyad that is not counted in the enrollment number - they were unable to be randomized after enrollment due to home safety concerns.
Participants by arm
| Arm | Count |
|---|---|
| People Living With Dementia: Timed Activity Intervention Protocol The timed activity group will be delivered to caregivers and persons living with dementia, and 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.
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. | 105 |
| Persons Living With Dementia: Attention-Control Condition The attention control group sessions will be delivered to caregivers and persons living with dementia.
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.
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. | 105 |
| Caregivers of Persons Living With Dementia: Timed Activity Intervention Protocol The timed activity group will be delivered to caregivers and persons living with dementia, and 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.
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. | 105 |
| Caregivers of Persons Living With Dementia: Attention-Control Condition The attention control group sessions will be delivered to caregivers and persons living with dementia.
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.
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. | 105 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 7 | 4 | 7 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 3 | 7 | 3 | 0 |
Baseline characteristics
| Characteristic | People Living With Dementia: Timed Activity Intervention Protocol | Persons Living With Dementia: Attention-Control Condition | Caregivers of Persons Living With Dementia: Timed Activity Intervention Protocol | Caregivers of Persons Living With Dementia: Attention-Control Condition | Total |
|---|---|---|---|---|---|
| Age, Continuous | 73.5 years STANDARD_DEVIATION 8.4 | 73.9 years STANDARD_DEVIATION 8.9 | 57.5 years STANDARD_DEVIATION 14.2 | 55.6 years STANDARD_DEVIATION 15.3 | 65.13 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 21 Participants | 18 Participants | 21 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 83 Participants | 85 Participants | 83 Participants | 336 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 65 Participants | 70 Participants | 64 Participants | 70 Participants | 269 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 39 Participants | 34 Participants | 40 Participants | 34 Participants | 147 Participants |
| Sex: Female, Male Female | 67 Participants | 72 Participants | 67 Participants | 72 Participants | 278 Participants |
| Sex: Female, Male Male | 37 Participants | 33 Participants | 37 Participants | 33 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 105 | 0 / 105 | 0 / 105 | 0 / 105 |
| other Total, other adverse events | 1 / 1 | 6 / 105 | 5 / 105 | 0 / 105 | 0 / 105 |
| serious Total, serious adverse events | 0 / 1 | 0 / 105 | 0 / 105 | 0 / 105 | 0 / 105 |
Outcome results
Primary
Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale
Person living 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. Total scores are calculated by summing all domain scores. The total score range is 13 to 52, with higher scores indicating higher quality of life. Total scores were analyzed to see if there was a change from baseline to one month. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. Change scores are reported.
Time frame: Baseline and 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People Living With Dementia: Timed Activity Intervention Protocol | Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale | 0.56 scores on a scale | Standard Deviation 4.06 |
| Persons Living With Dementia: Attention-Control Condition | Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale | -0.47 scores on a scale | Standard Deviation 5.16 |
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).
Time frame: 4 Months
Other Pre-specified
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.
Time frame: 30 days