A Phase 3 interventional study of Attention-Control Condition and Timed Activity Intervention in Dementia, Alzheimer Disease and Circadian Rhythm Disorders, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by University of Pennsylvania · Phase 3, Interventional, and Supportive care
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.
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.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's enrollment of 421 is above the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for care receiver (CR):
Inclusion criteria for caregiver (CG):
Exclusion criteria for CR:
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
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.
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.
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
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
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
| Milestone | Caregivers of Persons Living With Dementia: Timed Activity Intervention Protocol | Caregivers of Persons Living With Dementia: Attention-Control Condition | People Living With Dementia: Timed Activity Intervention Protocol | Persons Living With Dementia: Attention-Control Condition | Unrandomized |
|---|---|---|---|---|---|
| Started | 105 | 105 | 105 | 105 | 1 |
| Completed | 94 | 95 | 94 | 95 | 0 |
| Not completed | 11 | 10 | 11 | 10 | 1 |
| Withdrew: Lost to follow-up | 4 | 7 | 4 | 7 | 1 |
| Withdrew: Withdrawal by subject | 7 | 3 | 7 | 3 | 0 |
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.
| scores on a scale | People Living With Dementia: Timed Activity Intervention Protocol | Persons Living With Dementia: Attention-Control Condition |
|---|---|---|
| Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale | 0.56 ± 4.06 | -0.47 ± 5.16 |
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).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Adverse event data were collected during time of participant enrollment (one month of active participation, three-month follow-up after completion of study).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unrandomized | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| People Living With Dementia: Timed Activity Intervention Protocol | 0/105 (0%) | 0/105 (0%) | 6/105 (5.7%) |
| Persons Living With Dementia: Attention-Control Condition | 0/105 (0%) | 0/105 (0%) | 5/105 (4.8%) |
| Caregivers of Persons Living With Dementia: Timed Activity Intervention Protocol | 0/105 (0%) | 0/105 (0%) | 0/105 (0%) |
| Caregivers of Persons Living With Dementia: Attention-Control Condition | 0/105 (0%) | 0/105 (0%) | 0/105 (0%) |
| Event | Unrandomized | 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 |
|---|---|---|---|---|---|
| InfestationInfections and infestations | 1/1 | 0/105 | 0/105 | 0/105 | 0/105 |
| HospitalizationInjury, poisoning and procedural complications | 0/1 | 2/105 | 4/105 | 0/105 | 0/105 |
| FallInjury, poisoning and procedural complications | 0/1 | 1/105 | 1/105 | 0/105 | 0/105 |
| Caregiver agitationSocial circumstances | 0/1 | 1/105 | 0/105 | 0/105 | 0/105 |
| WanderingSocial circumstances | 0/1 | 1/105 | 0/105 | 0/105 | 0/105 |
| Lack of caregiver supportSocial circumstances | 0/1 | 1/105 | 0/105 | 0/105 | 0/105 |
| Age, Continuous(years) | 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 |
|---|---|---|---|---|---|
| Mean | 73.5 ± 8.4 | 73.9 ± 8.9 | 57.5 ± 14.2 | 55.6 ± 15.3 | 65.13 ± 11.7 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|
| Female | 67 | 72 | 67 | 72 | 278 |
| Male | 37 | 33 | 37 | 33 | 140 |
| Ethnicity (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|
| Hispanic or Latino | 18 | 21 | 18 | 21 | 78 |
| Not Hispanic or Latino | 85 | 83 | 85 | 83 | 336 |
| Unknown or Not Reported | 1 | 1 | 1 | 1 | 4 |
| Race (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 65 | 70 | 64 | 70 | 269 |
| White | 39 | 34 | 40 | 34 | 147 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 1 | 1 | 4 |
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