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| ID | Type | Description | Link |
|---|---|---|---|
| T32AG057461 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Individuals with dementia present with changes in behaviors throughout the continuum of cognitive decline. Environmental features may be influential in behavioral regulation. The purpose of this study is to assess the feasibility of environmental design protocols in older adults with dementia and their caregivers. Thirty subjects with moderate to severe Alzheimer's disease as primary dementia type, and their caregivers, will be randomly assigned to one of three arms: standard care; standard environmental design protocol; or personalized environmental design protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Alzheimer's disease patients and caregivers. |
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| Standard Environmental Design | Experimental | Alzheimer's disease patients and caregivers. |
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| Individualized Environmental Design Protocol | Experimental | Alzheimer's disease patients and caregivers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Environmental Design | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Adherence | Percentage of participants who had 75% adherence to the protocol based on visits and journals. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Occupational Performance | 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. | 10 weeks (at baseline, 6 weeks and the 4 week follow up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Jicha, MD-PhD | University of Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentcuky | Lexington | Kentucky | 40536 | United States |
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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.
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)
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications. |
| BG001 | Standard Environmental Design |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Numbers of participants analyzed differ to drop of from study prior to study completion. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate of Adherence | Percentage of participants who had 75% adherence to the protocol based on visits and journals. | Difference of success rates among participants | Posted | Count of Participants | Participants | 6 weeks |
|
10 weeks
Mortality and Adverse Events were not monitored/collected for caregivers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Alzheimer's disease patients and caregivers. Placebo: Participants' caregivers will receive a set script of placebo modifications. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Rhodus | University of Kentucky | 859-257-5567 | elizabeth.rhodus@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 10, 2022 | Nov 22, 2022 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Individual Environmental Design | Behavioral | 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. |
|
| Placebo | Behavioral | Participants' caregivers will receive a set script of placebo modifications. |
|
| Change in Behavior |
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. |
| 10 weeks (at baseline, 6 weeks and the 4 week follow up) |
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion. | Mean | Standard Deviation | years |
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| Length of Caregiving Relationship | Measure Analysis Population Description: Numbers of participants analyzed differ to drop of from study prior to study completion. | Mean | Standard Deviation | years |
|
| OG002 | 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. |
|
|
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| Secondary | Change in Occupational Performance | 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. | Discontinued Intervention | Posted | Mean | Standard Error | score on a scale | 10 weeks (at baseline, 6 weeks and the 4 week follow up) |
|
|
|
| Secondary | Change in Behavior | 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. | Posted | Mean | Standard Error | score on a scale | 10 weeks (at baseline, 6 weeks and the 4 week follow up) |
|
|
|
| 1 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | 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. | 1 | 10 | 0 | 10 | 0 | 10 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Male |
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| Title | Measurements |
|---|---|
| Female |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|
| Post Intervention |
|
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| 4-week follow up |
|
|
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| 4-week follow up |
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