Trial Outcomes & Findings for The Healthy Patterns Sleep Study (NCT NCT03682185)

Last Updated: 2024-07-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

421 participants

Primary outcome timeframe

Baseline and 1 month

Results posted on

2024-07-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	Unrandomized Unrandomized Participants who were consented but didn't move forward in the intervention.
Overall Study STARTED	105	105	105	105	1
Overall Study COMPLETED	94	95	94	95	0
Overall Study NOT COMPLETED	11	10	11	10	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	Unrandomized Unrandomized Participants who were consented but didn't move forward in the intervention.
Overall Study Lost to Follow-up	4	7	4	7	1
Overall Study Withdrawal by Subject	7	3	7	3	0

Baseline Characteristics

Some demographic characteristics missing for two participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	People Living With Dementia: Timed Activity Intervention Protocol n=105 Participants 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.	Persons Living With Dementia: Attention-Control Condition n=105 Participants 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.	Caregivers of Persons Living With Dementia: Timed Activity Intervention Protocol n=105 Participants 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.	Caregivers of Persons Living With Dementia: Attention-Control Condition n=105 Participants 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.	Total n=420 Participants Total of all reporting groups
Age, Continuous	73.5 years STANDARD_DEVIATION 8.4 • n=104 Participants • Some demographic characteristics missing for two participants.	73.9 years STANDARD_DEVIATION 8.9 • n=104 Participants • Some demographic characteristics missing for two participants.	57.5 years STANDARD_DEVIATION 14.2 • n=96 Participants • Some demographic characteristics missing for two participants.	55.6 years STANDARD_DEVIATION 15.3 • n=95 Participants • Some demographic characteristics missing for two participants.	65.13 years STANDARD_DEVIATION 11.7 • n=399 Participants • Some demographic characteristics missing for two participants.
Sex: Female, Male Female	67 Participants n=104 Participants • Some demographic characteristics missing for two participants.	72 Participants n=105 Participants • Some demographic characteristics missing for two participants.	67 Participants n=104 Participants • Some demographic characteristics missing for two participants.	72 Participants n=105 Participants • Some demographic characteristics missing for two participants.	278 Participants n=418 Participants • Some demographic characteristics missing for two participants.
Sex: Female, Male Male	37 Participants n=104 Participants • Some demographic characteristics missing for two participants.	33 Participants n=105 Participants • Some demographic characteristics missing for two participants.	37 Participants n=104 Participants • Some demographic characteristics missing for two participants.	33 Participants n=105 Participants • Some demographic characteristics missing for two participants.	140 Participants n=418 Participants • Some demographic characteristics missing for two participants.
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=104 Participants • Some demographic characteristics missing for two participants.	21 Participants n=105 Participants • Some demographic characteristics missing for two participants.	18 Participants n=104 Participants • Some demographic characteristics missing for two participants.	21 Participants n=105 Participants • Some demographic characteristics missing for two participants.	78 Participants n=418 Participants • Some demographic characteristics missing for two participants.
Ethnicity (NIH/OMB) Not Hispanic or Latino	85 Participants n=104 Participants • Some demographic characteristics missing for two participants.	83 Participants n=105 Participants • Some demographic characteristics missing for two participants.	85 Participants n=104 Participants • Some demographic characteristics missing for two participants.	83 Participants n=105 Participants • Some demographic characteristics missing for two participants.	336 Participants n=418 Participants • Some demographic characteristics missing for two participants.
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=104 Participants • Some demographic characteristics missing for two participants.	1 Participants n=105 Participants • Some demographic characteristics missing for two participants.	1 Participants n=104 Participants • Some demographic characteristics missing for two participants.	1 Participants n=105 Participants • Some demographic characteristics missing for two participants.	4 Participants n=418 Participants • Some demographic characteristics missing for two participants.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=420 Participants
Race (NIH/OMB) Asian	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=420 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=420 Participants
Race (NIH/OMB) Black or African American	65 Participants n=105 Participants	70 Participants n=105 Participants	64 Participants n=105 Participants	70 Participants n=105 Participants	269 Participants n=420 Participants
Race (NIH/OMB) White	39 Participants n=105 Participants	34 Participants n=105 Participants	40 Participants n=105 Participants	34 Participants n=105 Participants	147 Participants n=420 Participants
Race (NIH/OMB) More than one race	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=105 Participants	0 Participants n=420 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=105 Participants	1 Participants n=105 Participants	1 Participants n=105 Participants	1 Participants n=105 Participants	4 Participants n=420 Participants

PRIMARY outcome

Timeframe: Baseline and 1 month

Outcome measures

Outcome measures
Measure	People Living With Dementia: Timed Activity Intervention Protocol n=105 Participants 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.	Persons Living With Dementia: Attention-Control Condition n=105 Participants 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.
Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale	0.56 scores on a scale Standard Deviation 4.06	-0.47 scores on a scale Standard Deviation 5.16

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.