Alzheimer Disease
Conditions
Keywords
environment, Occupational therapy
Brief summary
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.
Interventions
BEHAVIORALStandard 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.
BEHAVIORALIndividual 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.
BEHAVIORALPlacebo
Participants' caregivers will receive a set script of placebo modifications.
Sponsors
National Institute on Aging (NIA)
Elizabeth K Rhodus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or women aged 21-90, inclusive. * Living at home in the community with one primary caregiver. * Diagnosis of Alzheimer's disease as primary dementia type of moderate to severe stages * Stable medical condition for one month prior to screening visit * Stable medications for 4 weeks prior to screening visit * Caregiver report of challenges related to behaviors within 4 weeks of study enrollment * Caregiver willing to participant throughout duration of study
Exclusion criteria
* Unstable medical conditions for 3 months prior to screening * Wheelchair or bed bound. * Residence in skilled nursing facility or facility-based care. * Skin lesions or skin abnormalities throughout upper extremities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Adherence | 6 weeks | Percentage of participants who had 75% adherence to the protocol based on visits and journals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Occupational Performance | 10 weeks (at baseline, 6 weeks and the 4 week follow up) | 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. |
| Change in Behavior | 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. |
Countries
United States
Participant flow
Recruitment details
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)
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Alzheimer's disease patients and caregivers.
Placebo: Participants' caregivers will receive a set script of placebo modifications. | 10 |
| 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. | 10 |
| 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. | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Environmental Design | Total | Individualized Environmental Design Protocol | Control Group |
|---|---|---|---|---|
| Age, Continuous Caregiver | 67.7 years STANDARD_DEVIATION 11.6 | 69.0 years STANDARD_DEVIATION 11.7 | 69.7 years STANDARD_DEVIATION 11.7 | 69.5 years STANDARD_DEVIATION 14 |
| Age, Continuous PLWD | 84.3 years STANDARD_DEVIATION 5.4 | 77.9 years STANDARD_DEVIATION 7.9 | 73.3 years STANDARD_DEVIATION 7.1 | 77.2 years STANDARD_DEVIATION 7.4 |
| Education Caregiver | 16.3 years STANDARD_DEVIATION 1.6 | 16.3 years STANDARD_DEVIATION 2.2 | 17.0 years STANDARD_DEVIATION 2.4 | 15.3 years STANDARD_DEVIATION 2.5 |
| Education PLWD | 14.6 years STANDARD_DEVIATION 2.1 | 15.0 years STANDARD_DEVIATION 2.4 | 15.6 years STANDARD_DEVIATION 2 | 14.7 years STANDARD_DEVIATION 3.2 |
| Length of Caregiving Relationship | 3.3 years STANDARD_DEVIATION 2.9 | 4.4 years STANDARD_DEVIATION 3.5 | 5.6 years STANDARD_DEVIATION 3.9 | 3.7 years STANDARD_DEVIATION 3.5 |
| Race (NIH/OMB) Caregiver American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Caregiver More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver White | 10 Participants | 29 Participants | 10 Participants | 9 Participants |
| Race (NIH/OMB) PLWD American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PLWD Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PLWD Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) PLWD More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PLWD Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PLWD Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PLWD White | 10 Participants | 29 Participants | 10 Participants | 9 Participants |
| Region of Enrollment United States | 10 participants | 30 participants | 10 participants | 10 participants |
| Sex: Female, Male Caregiver Female | 8 Participants | 19 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Caregiver Male | 2 Participants | 11 Participants | 8 Participants | 1 Participants |
| Sex: Female, Male PLWD Female | 7 Participants | 21 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male PLWD Male | 3 Participants | 9 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 0 / 10 | 1 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Success Rate of Adherence
Percentage of participants who had 75% adherence to the protocol based on visits and journals.
Time frame: 6 weeks
Population: Difference of success rates among participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Success Rate of Adherence | 2 Participants |
| Standard Environmental Design | Success Rate of Adherence | 6 Participants |
| Individualized Environmental Design Protocol | Success Rate of Adherence | 7 Participants |
Comparison: Primary outcome analyzed via success rates among groups.p-value: 0.12Fisher Exact
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.
Time frame: 10 weeks (at baseline, 6 weeks and the 4 week follow up)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Behavior | Post-Intervention | 8.9 score on a scale | Standard Error 2.5 |
| Control Group | Change in Behavior | Baseline | 13.3 score on a scale | Standard Error 2.3 |
| Control Group | Change in Behavior | 4-week follow up | 5.4 score on a scale | Standard Error 2.7 |
| Standard Environmental Design | Change in Behavior | Post-Intervention | 10.8 score on a scale | Standard Error 1.9 |
| Standard Environmental Design | Change in Behavior | Baseline | 9.8 score on a scale | Standard Error 2.8 |
| Standard Environmental Design | Change in Behavior | 4-week follow up | 5.5 score on a scale | Standard Error 3 |
| Individualized Environmental Design Protocol | Change in Behavior | Baseline | 10.3 score on a scale | Standard Error 1.7 |
| Individualized Environmental Design Protocol | Change in Behavior | 4-week follow up | 5.8 score on a scale | Standard Error 3.7 |
| Individualized Environmental Design Protocol | Change in Behavior | Post-Intervention | 8.4 score on a scale | Standard Error 1.7 |
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.
Time frame: 10 weeks (at baseline, 6 weeks and the 4 week follow up)
Population: Discontinued Intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Occupational Performance | Post Intervention | 4.6 score on a scale | Standard Error 1.6 |
| Control Group | Change in Occupational Performance | Baseline | 4.6 score on a scale | Standard Error 0.4 |
| Control Group | Change in Occupational Performance | 4-week follow up | 5 score on a scale | Standard Error 1.4 |
| Standard Environmental Design | Change in Occupational Performance | Post Intervention | 6.1 score on a scale | Standard Error 1.1 |
| Standard Environmental Design | Change in Occupational Performance | Baseline | 3.6 score on a scale | Standard Error 0.8 |
| Standard Environmental Design | Change in Occupational Performance | 4-week follow up | 5.2 score on a scale | Standard Error 2.6 |
| Individualized Environmental Design Protocol | Change in Occupational Performance | Baseline | 4.4 score on a scale | Standard Error 0.8 |
| Individualized Environmental Design Protocol | Change in Occupational Performance | 4-week follow up | 6.4 score on a scale | Standard Error 2.6 |
| Individualized Environmental Design Protocol | Change in Occupational Performance | Post Intervention | 6.6 score on a scale | Standard Error 0.9 |