Trial Outcomes & Findings for Environmental Design for Behavioral Regulation in People With Dementia (NCT NCT04555616)

NCT ID: NCT04555616

Last Updated: 2023-04-12

Results Overview

Percentage of participants who had 75% adherence to the protocol based on visits and journals.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

6 weeks

Results posted on

2023-04-12

Participant Flow

Individuals diagnosed with Alzheimer's disease (Clinical Dementia Rating Scale \[CDR\] score of 1.0+) living in the community with caregiver-identified behavioral disturbance were recruited from the UK Alzheimer's Disease Research Center (UK ADRC)

Of 96 patient-caregiver dyads, 60 dyads were excluded (52 did not meet inclusion criteria; 4 declined to participate; 10 for other reasons.) Patients and their caregivers were enrolled as dyads. 30 dyads were randomized (10 to control, 10 to Standardized, 10 to Individualized) and 25 dyads completed the study.

Participant milestones

Participant milestones
Measure	Control Group Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications.	Standard Environmental Design Alzheimer's disease patients and caregivers. Standard Environmental Design: Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.	Individualized Environmental Design Protocol Alzheimer's disease patients and caregivers. Individual Environmental Design: Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.
Overall Study STARTED	10	10	10
Overall Study COMPLETED	7	9	9
Overall Study NOT COMPLETED	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications.	Standard Environmental Design Alzheimer's disease patients and caregivers. Standard Environmental Design: Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.	Individualized Environmental Design Protocol Alzheimer's disease patients and caregivers. Individual Environmental Design: Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.
Overall Study Death	1	0	1
Overall Study Withdrawal by Subject	2	1	0

Baseline Characteristics

Numbers of participants analyzed differ to drop of from study prior to study completion.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 weeks

Population: Difference of success rates among participants

Percentage of participants who had 75% adherence to the protocol based on visits and journals.

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications.	Standard Environmental Design n=10 Participants Alzheimer's disease patients and caregivers. Standard Environmental Design: Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.	Individualized Environmental Design Protocol n=10 Participants Alzheimer's disease patients and caregivers. Individual Environmental Design: Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.
Success Rate of Adherence	2 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: 10 weeks (at baseline, 6 weeks and the 4 week follow up)

Population: Discontinued Intervention

Occupational performance will be measured using the Canadian Occupational Performance Measure (COPM) at baseline, post-intervention and the 4-week follow up. Scores range from 0-10; higher scores indicate (increased) occupational performance.

Outcome measures

Outcome measures
Measure	Control Group n=7 Participants Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications.	Standard Environmental Design n=7 Participants Alzheimer's disease patients and caregivers. Standard Environmental Design: Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.	Individualized Environmental Design Protocol n=8 Participants Alzheimer's disease patients and caregivers. Individual Environmental Design: Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.
Change in Occupational Performance Baseline	4.6 score on a scale Standard Error 0.4	3.6 score on a scale Standard Error 0.8	4.4 score on a scale Standard Error 0.8
Change in Occupational Performance Post Intervention	4.6 score on a scale Standard Error 1.6	6.1 score on a scale Standard Error 1.1	6.6 score on a scale Standard Error 0.9
Change in Occupational Performance 4-week follow up	5 score on a scale Standard Error 1.4	5.2 score on a scale Standard Error 2.6	6.4 score on a scale Standard Error 2.6

SECONDARY outcome

Timeframe: 10 weeks (at baseline, 6 weeks and the 4 week follow up)

Behavior will be measured using the Neuropsychiatric Inventory (NPI-Q) at baseline, post-intervention and the 4-week follow up. Scores range from 1-36; higher scores indicate higher behavior severity.

Outcome measures

Outcome measures
Measure	Control Group n=6 Participants Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications.	Standard Environmental Design n=6 Participants Alzheimer's disease patients and caregivers. Standard Environmental Design: Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.	Individualized Environmental Design Protocol n=7 Participants Alzheimer's disease patients and caregivers. Individual Environmental Design: Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.
Change in Behavior 4-week follow up	5.4 score on a scale Standard Error 2.7	5.5 score on a scale Standard Error 3.0	5.8 score on a scale Standard Error 3.7
Change in Behavior Baseline	13.3 score on a scale Standard Error 2.3	9.8 score on a scale Standard Error 2.8	10.3 score on a scale Standard Error 1.7
Change in Behavior Post-Intervention	8.9 score on a scale Standard Error 2.5	10.8 score on a scale Standard Error 1.9	8.4 score on a scale Standard Error 1.7

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard Environmental Design

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Individualized Environmental Design Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Rhodus

University of Kentucky

Phone: 859-257-5567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control Group n=10 Participants Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications.	Standard Environmental Design n=10 Participants Alzheimer's disease patients and caregivers. Standard Environmental Design: Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.	Individualized Environmental Design Protocol n=10 Participants Alzheimer's disease patients and caregivers. Individual Environmental Design: Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.	Total n=30 Participants Total of all reporting groups
Age, Continuous PLWD	77.2 years STANDARD_DEVIATION 7.4 • n=6 Participants • Numbers of participants analyzed differ to drop of from study prior to study completion.	84.3 years STANDARD_DEVIATION 5.4 • n=7 Participants • Numbers of participants analyzed differ to drop of from study prior to study completion.	73.3 years STANDARD_DEVIATION 7.1 • n=9 Participants • Numbers of participants analyzed differ to drop of from study prior to study completion.	77.9 years STANDARD_DEVIATION 7.9 • n=22 Participants • Numbers of participants analyzed differ to drop of from study prior to study completion.
Age, Continuous Caregiver	69.5 years STANDARD_DEVIATION 14.0 • n=6 Participants • Numbers of participants analyzed differ to drop of from study prior to study completion.	67.7 years STANDARD_DEVIATION 11.6 • n=7 Participants • Numbers of participants analyzed differ to drop of from study prior to study completion.	69.7 years STANDARD_DEVIATION 11.7 • n=9 Participants • Numbers of participants analyzed differ to drop of from study prior to study completion.	69.0 years STANDARD_DEVIATION 11.7 • n=22 Participants • Numbers of participants analyzed differ to drop of from study prior to study completion.
Sex: Female, Male PLWD · Female	6 Participants n=10 Participants	7 Participants n=10 Participants	8 Participants n=10 Participants	21 Participants n=30 Participants
Sex: Female, Male PLWD · Male	4 Participants n=10 Participants	3 Participants n=10 Participants	2 Participants n=10 Participants	9 Participants n=30 Participants
Sex: Female, Male Caregiver · Female	9 Participants n=10 Participants	8 Participants n=10 Participants	2 Participants n=10 Participants	19 Participants n=30 Participants
Sex: Female, Male Caregiver · Male	1 Participants n=10 Participants	2 Participants n=10 Participants	8 Participants n=10 Participants	11 Participants n=30 Participants
Race (NIH/OMB) PLWD · American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) PLWD · Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) PLWD · Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) PLWD · Black or African American	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=30 Participants
Race (NIH/OMB) PLWD · White	9 Participants n=10 Participants	10 Participants n=10 Participants	10 Participants n=10 Participants	29 Participants n=30 Participants
Race (NIH/OMB) PLWD · More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) PLWD · Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Caregiver · American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Caregiver · Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Caregiver · Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Caregiver · Black or African American	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=30 Participants
Race (NIH/OMB) Caregiver · White	9 Participants n=10 Participants	10 Participants n=10 Participants	10 Participants n=10 Participants	29 Participants n=30 Participants
Race (NIH/OMB) Caregiver · More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Caregiver · Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Region of Enrollment United States	10 participants n=10 Participants	10 participants n=10 Participants	10 participants n=10 Participants	30 participants n=30 Participants
Education PLWD	14.7 years STANDARD_DEVIATION 3.2 • n=7 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	14.6 years STANDARD_DEVIATION 2.1 • n=7 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	15.6 years STANDARD_DEVIATION 2.0 • n=9 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	15.0 years STANDARD_DEVIATION 2.4 • n=23 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.
Education Caregiver	15.3 years STANDARD_DEVIATION 2.5 • n=7 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	16.3 years STANDARD_DEVIATION 1.6 • n=8 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	17.0 years STANDARD_DEVIATION 2.4 • n=10 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	16.3 years STANDARD_DEVIATION 2.2 • n=25 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.
Length of Caregiving Relationship	3.7 years STANDARD_DEVIATION 3.5 • n=7 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	3.3 years STANDARD_DEVIATION 2.9 • n=5 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	5.6 years STANDARD_DEVIATION 3.9 • n=8 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.	4.4 years STANDARD_DEVIATION 3.5 • n=20 Participants • Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion.